This page shows what was measured, who it was measured in, and what that does not settle.
What Dupilumab does in the body
Eczema, asthma and other diseases driven by the same allergic pathway
Two allergic signalling molecules, IL-4 and IL-13, both have to plug into the same socket to do their work. Dupilumab caps that one socket. Both messengers are shut out at once, and the allergic programme they drive in skin, airway and gullet winds down. It does not suppress the immune system generally, which is why there is no boxed infection warning.
What happened in people
IGA 0 or 1 with 2-point reduction at 16 weeks in 37-38% versus 10% on placebo, replicated across two identical trials
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
That every type 2 inflammatory condition will respond; the COPD approval is restricted to raised eosinophils and CUPID Study B failed in omalizumab-refractory urticaria
Where it acts
Skin, airway and oesophageal epithelium and the immune cells within them
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · 420K487FSG · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 95 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Sleep
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Sleep
wake after sleep onset
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
— Not recorded
Harms were not a registered measure for this goal.
… Waiting for a reviewer
Who was studied is listed further down the page.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Results from the one trial this record names
In NCT02277743, Percentage of participants with an Investigator Global Assessment score of 0 or 1 and a reduction from baseline of at least 2 points at Week 16: primary endpoint, dupilumab 300 mg every 2 weeks compared with placebo was Dupilumab every-2-week arm, 224 participants: 37.9% against Placebo arm, 224 participants: 10.3% in the comparison group at Week 16.
ClinicalTrials.gov record · NCT02277743 · read 2026-08-28
In NCT02277743, Posted between-group analysis of the same primary endpoint: difference in the percentage of participants reaching an Investigator Global Assessment score of 0 or 1 with a reduction of at least 2 points was Dupilumab 300 mg q2w versus placebo: difference in percentages 27.7 at Week 16. The recorded difference is 27.7 percentage points (95% two-sided confidence interval 20.18 to 35.17; p < 0.0001 by Cochran-Mantel-Haenszel test, with the threshold for significance at the 0.025 level).
ClinicalTrials.gov record · NCT02277743 · read 2026-08-28
IGA score 0 or 1 with at least a 2-point reduction at week 16
✓ The study showed what it set out to show
Who was studied
SOLO 1 (NCT02277743)
How many people
671
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
p < 0.001 for both dupilumab regimens versus placebo
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Subcutaneous prefilled syringe or autoinjector pen
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
ClinicalTrials.gov, SOLO 1 (NCT02277743) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 3 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
□Living longer, or avoiding a major eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Where a source records it acting
Immune and lymphatic system: Blocks the IL-4 receptor alpha subunit on the multiple cell types that express it, including mast cells, basophils, eosinophils, macrophages and lymphocytes, inhibiting IL-4 and IL-13 cytokine-induced inflammatory responses
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-28
Nose and upper airway: Recorded as an add-on maintenance treatment for inadequately controlled chronic rhinosinusitis with nasal polyps
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-28
Lungs and airways: Recorded as an add-on maintenance treatment for moderate-to-severe asthma of an eosinophilic phenotype or oral corticosteroid dependent asthma, with the label noting it is not for the relief of acute bronchospasm
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-28
Start
Dupilumab
What a person takes: Subcutaneous prefilled syringe or autoinjector pen.
The measurement behind this step
Loading dose followed by 200 mg or 300 mg every two weeks, or every four weeks in some paediatric and COPD regimens, self-administered at home after training.
Getting in
Subcutaneous self-injection every two weeks
A prefilled pen delivers the antibody under the skin of the thigh or abdomen, usually after a double loading dose.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Typically 600 mg loading then 300 mg every other week in adult atopic dermatitis, with weight-banded paediatric regimens. Absorption is lymphatic with bioavailability around 60% and time to peak of about one week.
It travels in the blood to the tissues where the allergic programme is running: the skin, the lining of the airways, the sinuses and the gullet.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Non-linear, target-mediated disposition at low concentration reflects binding to IL-4Ralpha on tissue-resident cells; clearance becomes approximately linear once the receptor pool is saturated.
Both allergic messengers need the same socket. The antibody caps it, so neither can connect, from one binding event.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Binds IL-4Ralpha, blocking assembly of both the type I receptor (IL-4Ralpha with the common gamma chain, used by IL-4) and the type II receptor (IL-4Ralpha with IL-13Ralpha1, used by both IL-4 and IL-13).
STAT6 signalling stops and the type 2 programme unwinds
Inside the cell, the master switch for allergic inflammation is never thrown. Antibody class switching, mucus production and barrier disruption all fall away over the following weeks.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Without receptor assembly, JAK1, JAK3 and TYK2 do not phosphorylate STAT6, so the STAT6-dependent programme fails to run: reduced IgE class switching, lower periostin and TARC, restored filaggrin and loricrin expression, less goblet cell metaplasia and less eosinophil chemotaxis via eotaxin-3.
Skin heals and stops itching, asthma attacks become less frequent, polyps shrink and swallowing improves, depending on which organ was affected.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Restored epidermal barrier protein expression and reduced Staphylococcus aureus colonisation in skin, reduced airway eosinophilia and fractional exhaled nitric oxide in asthma, and reduced oesophageal eosinophil counts in eosinophilic oesophagitis.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults and children from six months of age with moderate-to-severe atopic dermatitis not controlled by topical therapy, and adults and adolescents with type 2 inflammatory disease of the airway, sinuses or oesophagus.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
Who a named study recorded including and excluding
NCT02277743 recorded its participants as: Adults 18 years and older, all sexes; not healthy volunteers.
ClinicalTrials.gov record · NCT02277743 · read 2026-08-28
It included: Male or female, 18 years or older; Chronic AD (according to American Academy of Dermatology Consensus Criteria Eichenfield 2014) that has been present for at least 3 years before the screening visit; Eczema Area and Severity Index (EASI) Score at least 16 at the screening and baseline visits; Investigator Global Assessment (IGA) Score at least 3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and baseline visits; At least 10% body surface area (BSA) of AD involvement at the screening and baseline visits.
ClinicalTrials.gov record · NCT02277743 · read 2026-08-28
It excluded: Participation in a prior Dupilumab clinical study; Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever was longer, before the baseline visit; Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week before the baseline visit; Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit; Known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution; History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
ClinicalTrials.gov record · NCT02277743 · read 2026-08-28
What the label states about particular groups
On pediatric, the label states: “Use of DUPIXENT in this age group is supported by data from the following clinical trials: AD-1526 which included 251 pediatric subjects 12 years of age and older with moderate-to-severe AD.”
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-30
On older people, the label states: “Clinical trials of DUPIXENT in AD did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.”
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-30
On people who are pregnant, the label states: “Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy.”
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of dupilumab in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-30
Where the result stopped carrying
LIBERTY-CSU CUPID Study B missed its primary endpoint in omalizumab-refractory chronic spontaneous urticaria
The FDA required a replicate trial, CUPID-C, before approving the urticaria indication in the anti-IgE-naive population
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
There was nothing to correct
Where a level is already normal, topping it up may change nothing.
On this record: Transient blood eosinophilia after starting treatment reflects blocked tissue trafficking rather than worsening disease, and is usually self-limiting
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (9)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Subcutaneous prefilled syringe or autoinjector pen
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
The identity record classes it as Monoclonal Antibody (mAb).
No source is stored against this line.
What is in the pack
Loading dose followed by 200 mg or 300 mg every two weeks, or every four weeks in some paediatric and COPD regimens, self-administered at home after training.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
The recorded stepping schedule
What follows is the schedule printed on the label, recorded as it is written there. It is a record of what was done, not a recommendation.
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-28
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-28
Following the initial dose (adults with atopic dermatitis): 300 mg given every 2 weeks (Q2W)
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-28
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
No boxed warning. Conjunctivitis, injection site reactions, oral herpes and transient eosinophilia are the characteristic events. Hypersensitivity including serum sickness-like reaction is rare. Live vaccines should be avoided during treatment.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Dupilumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4765 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Subcutaneous prefilled syringe or autoinjector pen
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
8 products list this as an active ingredient in the United States drug directory. 8 of them contain it and nothing else.
FDA National Drug Code directory · 61755-940 · read 2026-08-29
They are sold as injection, solution and solution, taken subcutaneous.
FDA National Drug Code directory · 61755-940 · read 2026-08-29
The regulator's established pharmacologic class for it is antibodies, interleukin 4 receptor alpha antagonists [moa] and interleukin-4 receptor alpha antagonist [epc].
FDA National Drug Code directory · 61755-940 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-29
Dupixent is injection: clear to slightly opalescent solution in a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen at 300 mg/2 mL (150 mg/mL) and 200 mg/1.14 mL (175 mg/mL), recorded as prescription product; fda label in effect 2026-04-22 in the United States.
US prescribing information · 595f437d-2729-40bb-9c62-c8ece1f82780 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Dupilumab studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That every type 2 inflammatory condition will respond; the COPD approval is restricted to raised eosinophils and CUPID Study B failed in omalizumab-refractory urticaria
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the absence of a boxed infection warning means there is no immunological cost; the trials were not designed or long enough to settle long-term helminth or viral immunity questions
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Dupilumab are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
SOLO 1 and SOLO 2: clear or almost clear skin in 36-38% against 8-10% on placebo
In plain words
Two identically designed trials in 671 and 708 adults with moderate-to-severe eczema both hit their primary endpoint at 16 weeks, with itch, anxiety, depression and quality of life all improving alongside the skin.
What was measured
IGA 0/1 with 2-point reduction at week 16: 38% and 37% versus 10% placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised, placebo-controlled, 16-week phase 3 trials of identical design. In SOLO 1 the primary endpoint of Investigator Global Assessment 0 or 1 with a 2-point or greater reduction was met by 38% on every-other-week dupilumab and 37% weekly, against 10% on placebo. SOLO 2 reproduced the result. Pruritus numeric rating scale, HADS anxiety and depression scores and DLQI all improved.
Written into the record, not signed off as a reviewed claim
LIBERTY ASTHMA QUEST: fewer exacerbations and better lung function in uncontrolled asthma
In plain words
The same antibody, in the same pathway, reduced severe asthma attacks and improved breathing tests, with the largest effects in people who had high blood eosinophil counts to begin with.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised, double-blind, placebo-controlled 52-week trial in patients with uncontrolled moderate-to-severe asthma. Annualised severe exacerbation rate and pre-bronchodilator FEV1 both improved significantly, with effect size increasing across baseline eosinophil strata. Transient blood eosinophilia occurred in a minority, which is a direct consequence of blocking eosinophil tissue trafficking rather than production.
Written into the record, not signed off as a reviewed claim
LIBERTY-CSU CUPID Study B: the primary endpoint was missed in omalizumab-refractory hives
In plain words
In people whose chronic hives had already failed the anti-IgE antibody omalizumab, dupilumab did not meet its primary endpoint and the effects that were seen were small.
What was measured
Study B UAS7 difference -5.8; primary endpoint not met
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Study A, in 138 omalizumab-naive patients, met its endpoints with a UAS7 difference of -8.5 (95% CI -13.2 to -3.9). Study B, in 108 omalizumab-intolerant or incomplete responders and tested at alpha 0.043 after an interim analysis, missed its primary endpoint: UAS7 difference -5.8 (95% CI -11.4 to -0.3) with a non-significant numerical trend on itch. The authors state plainly that effects were small in this population. A replicate trial, CUPID-C, was required by the FDA before approval in the anti-IgE-naive population.
Written into the record, not signed off as a reviewed claim
Conjunctivitis is a real, drug-specific and mechanistically unexplained signal
In plain words
Eye inflammation happens far more often on dupilumab than on placebo in eczema trials, and far less often in asthma trials of the same drug. Nobody has established why.
What was measured
That conjunctivitis is a direct pharmacological consequence of IL-4Ralpha blockade in all populations
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Conjunctivitis was reported substantially more frequently on dupilumab than placebo in the atopic dermatitis programme, but not at the same rate in the asthma or nasal polyp programmes, suggesting an interaction with atopic dermatitis itself rather than a pure drug effect. Proposed mechanisms include loss of IL-13-dependent goblet cell mucin production in the conjunctiva and shifts in ocular surface Demodex or microbial populations. None has been established.
Source
DUPIXENT US Prescribing Information, Adverse Reactions, and the atopic dermatitis trial programme
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Type 2 inflammation replaced organ-based disease definitions
In plain words
Eczema, asthma, nasal polyps and a swallowing disorder used to be four specialties with four textbooks. One antibody working in all of them made a strong case that they are one mechanism presenting in four places.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Sequential approvals ran from atopic dermatitis (2017) through asthma (2018), chronic rhinosinusitis with nasal polyps (2019), eosinophilic oesophagitis (2022), prurigo nodularis (2022), COPD with raised eosinophils (2024) and chronic spontaneous urticaria (2025). The unifying claim is mechanistic: all are driven by IL-4 and IL-13 signalling through IL-4Ralpha. The counterexample matters too - the COPD approval is restricted to patients with elevated eosinophils, which shows the pathway framing is a biomarker-defined subset rather than a universal one.
Source
Sequence of FDA approvals under DUPIXENT BLA 761055
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Where else this substance is registered
RxNorm concept
1876376
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Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
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The identity record classes it as Monoclonal Antibody (mAb).
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Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
1 approved application covers products containing this substance. The earliest was BLA761055, approved 20170328 to REGENERON PHARMACEUTICALS.
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5 questions this page could not answer
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Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A human antibody against the shared IL-4 receptor alpha subunit that blocks both IL-4 and IL-13, taking 37-38% of adults with moderate-to-severe eczema to clear or almost clear skin at 16 weeks against 10% on placebo.
Recorded evidence blocks (12)
Q1
What did Dupilumab's largest trial (3930 people) and its longest (13 years) measure?
3930 people in Dupilumab's largest registered study, 13 years in its longest registered window, measuring Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration. ClinicalTrials.gov · 2026-09-01
56 phase2, 53 phase4, 45 na or unstated, 43 phase3, 20 phase1, 4 early phase1, 4 na; NCT03358693; 2029-12-31; no ageing endpoint recorded. Last human test completed 2026, NCT04550962.
Interpretation These counts include studies where Dupilumab was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
56
phase4
53
na or unstated
45
phase3
43
phase1
20
early phase1
4
2 more recorded rows
na
4
Last recorded human testNCT04550962
2026-06-18
recorded 2026-09-01 · last checked 2026-09-04
Q2
Dupilumab was tested only in human — what did it show?
Interpretation Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration — the recorded outcome words.
Show the evidence
humanNCT02407756
biomarker; Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration; 219
3 recorded entries; human; also "Dupilumab 300 mg", "Dupilumab 300 MG in 2 ML Prefilled Syringe"
Show the evidence
human
NCT04200755
Dupilumab 300Mg Solution for Injection
NCT04345367
Dupilumab 300 mg
NCT04596189
Dupilumab 300 MG in 2 ML Prefilled Syringe
recorded 2026-09-01 · last checked 2026-09-04
Q5
Could one person measure Dupilumab's effect on asthma exacerbation?
Asthma exacerbation: measured in Dupilumab's trials.
Interpretation asthma exacerbation is the recorded endpoint.
Show the evidence
biomarkers
asthma exacerbation; 2026-09-01
treatment emergent adverse events; 2026-09-01
bilateral endoscopic nasal polyp at week 16; 2026-09-01
eczema area and severity index 75 at week 16; 2026-09-01
investigator s global assessment 0 or 1 at week 16; 2026-09-01
changes of molecular profiles over time; 2026-09-01
14 more recorded rows
biomarkers
changes of molecular profiles associated treatment; 2026-09-01
biomarkers
changes of molecular profiles associated treatment response; 2026-09-01
biomarkers
severity of alopecia tool at week 24; 2026-09-01
biomarkers
snot 22; 2026-09-01
biomarkers
investigator s global assessment; 2026-09-01
biomarkers
asthma exacerbations; 2026-09-01
biomarkers
fev1; 2026-09-01
biomarkers
rate of major structural defects; 2026-09-01
biomarkers
peak pruritus numerical rating; 2026-09-01
biomarkers
symptoms; 2026-09-01
biomarkers
baseline characteristics; 2026-09-01
biomarkers
treatment responders; 2026-09-01
biomarkers
response to treatment/hand eczema severity; 2026-09-01
biomarkers
asthma control during the treatment; 2026-09-01
human trials at or under30
50
Not recorded for this substance
a recorded half-life
smallest human trial
0; NCT06188871; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q6
Which of achieving eczema area and severity index 75 at week 16, asthma control during the treatment and asthma exacerbation did Dupilumab's trials measure?
achieving eczema area and severity index 75 at week 16, asthma control during the treatment and asthma exacerbation lead 40 outcome terms across Dupilumab's trials. ClinicalTrials.gov · 2026-09-01
eczema area and severity index 75 at week 16, investigator s global assessment 0 or 1 at week 16, changes of molecular profiles over time, changes of molecular profiles associated treatment, changes of molecular profiles associated treatment response and severity of alopecia tool at week 24 follow.
Show the evidence
asthma exacerbation
1
treatment emergent adverse events
1
bilateral endoscopic nasal polyp at week 16
1
eczema area and severity index 75 at week 16
1
investigator s global assessment 0 or 1 at week 16
1
changes of molecular profiles over time
1
14 more recorded rows
changes of molecular profiles associated treatment
1
changes of molecular profiles associated treatment response
1
severity of alopecia tool at week 24
1
snot 22
1
investigator s global assessment
1
asthma exacerbations
1
fev1
1
rate of major structural defects
1
peak pruritus numerical rating
1
symptoms
1
baseline characteristics
1
treatment responders
1
response to treatment/hand eczema severity
1
asthma control during the treatment
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Dupilumab's 89 ongoing trials reports first?
Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit; Changes of molecular profiles over time; latest 2032-06-01
Show the evidence
Trial
NCT02612454
"Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)"; n 880; "Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit"; 2026-10-07
NCT03358693
"Molecular Signatures in Inflammatory Skin Disease"; n 300; "Changes of molecular profiles over time"; 2029-12-31
NCT03428646
"Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)"; n 858; "Registry Assessment: Baseline Characteristics"; 2027-03-30
NCT03694158
"Investigating Dupilumab's Effect in Asthma by Genotype"; n 150; "The rate of asthma exacerbations"; 2027-03
NCT03935971
"The Effects of Dupilumab on Allergic Contact Dermatitis"; n 17; "Change From Baseline in Investigator's Global Assessment (IGA) Score"; 2027-03-31
NCT03936335
"An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)"; n 3930; "Prevalence of MCMs"; 2027-01-21
14 further recorded trials
NCT03992417
"Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)"; n 955; "Baseline Characteristics: Medical history"; 2027-03-31
NCT04743791
"Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma"; n 30; "Change in mucociliary clearance (MCC) rate"; 2028-06
NCT04776694
"Compassionate Use or Expanded Access of Dupilumab"
NCT04959448
"Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)"; n 717; "Baseline Patient Characteristics"; 2027-03-25
NCT05013450
"Dupilumab_Metastatic NSCLC"; n 33; "Dose Limiting Toxicity (DLTs)"; 2030-09-18
NCT05042258
"Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis"; n 40; "PROMIS (Patient Reported Outcome Measurement Information System) parent-proxy score"; 2027-06
NCT05094570
"Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP"; n 20; "To demonstrate that dupilumab reduces staphylococcus aureus"; 2026-12-31
NCT05097287
"Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma"; n 1339; "Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population"; 2029-06-08
NCT05246267
"Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis"; n 60; "Change in Sinonasal outcome test (SNOT-22) score, scale 0-110, higher is worse outcome"; 2026-06
NCT05263206
"Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)"; n 284; "Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 24"; 2027-08-25
NCT05268107
"Ethnic Differences in Mechanisms of Action of Dupilumab"; n 30; "Difference in inflammatory response to dupilumab between Caucasian, Asian and African American patients with atopic dermatitis as measured by change in expression of interleukin4 (IL4) from week 0 to 2."; 2027-06
NCT05285839
"Dupixent and Narrowband UVB for Atopic Dermatitis"; n 40; "Investigators Global Assessment Score of score of 0 or 1"; 2024-12-15
NCT05347771
"Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents"; n 240; "Number of asthma exacerbations during the 12-month treatment period"; 2027-03-15
NCT05535738
"Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation"; n 45; "To collect and evaluate single-cell multiomics data (RNAseq, CITEseq, TCRseq)"; 2027-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which 26 trials of Dupilumab posted no result?
Posted no result
26 of 26 completed trials
Registrations
NCT01015027, NCT01385657, NCT01259323, NCT01537653, NCT05976360 and NCT05976373, and 20 more
Completion dates
oldest 2010-07; newest 2024-04-23
Show the evidence
Trial
NCT01015027
2010-07
NCT01385657
2012-03-31
NCT01259323
2012-07
NCT01537653
2012-10
NCT05976360
2015-01-17
NCT05976373
2015-03-30
14 further recorded trials
NCT02647086
2016-07
NCT03050151
2018-02-12
NCT04022447
2019-04-02
NCT03112577
2019-12-09
NCT03595488
2019-12-11
NCT03749135
2021-07-07
NCT05976386
2021-09-24
NCT04358224
2022-11-18
NCT05331755
2022-12-31
NCT05649579
2023-01-31
NCT03749148
2023-02-28
NCT05203380
2023-03-10
NCT04287608
2023-03-29
NCT04200755
2023-11-30
Q9
At the median, Dupilumab's trials enrolled 86 people — anything larger?
Median enrolment
86
Largest enrolment
3930
Registered trials counted
215
Q10
What do 4765 spontaneous reports say about Dupilumab — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Dupilumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 4765 reaction mentions were counted: conjunctivitis 841; rash 792; arthralgia 535; pruritus 521. open-targets-adr · CHEMBL2108675 · 2026-06-24
Show the evidence
conjunctivitis
841
rash
792
arthralgia
535
pruritus
521
erythema
437
condition aggravated
421
4 more recorded rows
dermatitis atopic
373
product dose omission issue
316
eczema
275
ocular hyperaemia
254
recorded 2026-06-24 · last checked 2026-09-04
Q11
Dupilumab and CYP2D6, CYP1A2 and CYP2C19: shared by which compounds?
CYP2D6, CYP1A2 and CYP2C19 appear in Dupilumab's recorded interaction sentences, 7 in all. openfda-label+europepmc · 2026-08-30
Cytochrome P450 Substrates The effects of dupilumab on the pharmacokinetics of midazolam (metabolized by CYP3A4), warfarin (metabolized by CYP2C9), omeprazole (metabolized by CYP2C19), metoprolol (metabolized by CYP2D6), and caffeine (metabolized by CYP1A2) were evaluated in a study with 12-13 evaluable subjects with AD (a SC loading dose of 600 mg followed by 300 mg SC weekly for six weeks).
CYP2C19pharmacokinetics
Cytochrome P450 Substrates The effects of dupilumab on the pharmacokinetics of midazolam (metabolized by CYP3A4), warfarin (metabolized by CYP2C9), omeprazole (metabolized by CYP2C19), metoprolol (metabolized by CYP2D6), and caffeine (metabolized by CYP1A2) were evaluated in a study with 12-13 evaluable subjects with AD (a SC loading dose of 600 mg followed by 300 mg SC weekly for six weeks).
CYP2C9pharmacokinetics
Cytochrome P450 Substrates The effects of dupilumab on the pharmacokinetics of midazolam (metabolized by CYP3A4), warfarin (metabolized by CYP2C9), omeprazole (metabolized by CYP2C19), metoprolol (metabolized by CYP2D6), and caffeine (metabolized by CYP1A2) were evaluated in a study with 12-13 evaluable subjects with AD (a SC loading dose of 600 mg followed by 300 mg SC weekly for six weeks).
CYP2D6
pharmacokinetics
The largest effect was observed for metoprolol (CYP2D6) with an increase in AUC of 29%.
clinical_pharmacology
The largest effect was observed for metoprolol (CYP2D6) with an increase in AUC of 29%. 12.6 Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay.
pharmacokinetics
Cytochrome P450 Substrates The effects of dupilumab on the pharmacokinetics of midazolam (metabolized by CYP3A4), warfarin (metabolized by CYP2C9), omeprazole (metabolized by CYP2C19), metoprolol (metabolized by CYP2D6), and caffeine (metabolized by CYP1A2) were evaluated in a study with 12-13 evaluable subjects with AD (a SC loading dose of 600 mg followed by 300 mg SC weekly for six weeks).
CYP3A4pharmacokinetics
Cytochrome P450 Substrates The effects of dupilumab on the pharmacokinetics of midazolam (metabolized by CYP3A4), warfarin (metabolized by CYP2C9), omeprazole (metabolized by CYP2C19), metoprolol (metabolized by CYP2D6), and caffeine (metabolized by CYP1A2) were evaluated in a study with 12-13 evaluable subjects with AD (a SC loading dose of 600 mg followed by 300 mg SC weekly for six weeks).
recorded 2026-08-30 · last checked 2026-09-04
Q12
What is recorded about Dupilumab and mTOR?
"Recently approved indications or uses include dupilumab for adult bullous pemphigoid, IL-36 receptor blockade, topical COL7A1 gene delivery, autologous gene-corrected epidermal sheets, MEK inhibition, IL-1 blockade, and topical mTOR inhibition; JAK-interferon strategies remain investigational." — where Dupilumab and mTOR appear together. Europe PMC · pathway abstract search · 2026-08-01
mTOR; PMID 42643679
Show the evidence
mTORPMID 42643679
"Recently approved indications or uses include dupilumab for adult bullous pemphigoid, IL-36 receptor blockade, topical COL7A1 gene delivery, autologous gene-corrected epidermal sheets, MEK inhibition, IL-1 blockade, and topical mTOR inhibition; JAK-interferon strategies remain investigational."
recorded 2026-08-01 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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✓ source coverage passed: 11 source rows
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