This page shows what was measured, who it was measured in, and what that does not settle.
What Tralokinumab does in the body
Moderate-to-severe atopic dermatitis
From the FDA-approved label: Tralokinumab-ldrm is a human IgG4 monoclonal antibody that specifically binds to human interleukin-13 (IL-13) and inhibits its interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2). IL-13 is a naturally occurring cytokine of the Type 2 immune response. Tralokinumab-ldrm inhibits the bioactivity of IL-13 by blocking IL-13 interaction with IL-13Rα1/IL-4Rα receptor complex. Tralokinumab-ldrm inhibits IL-13-induced responses including the release of proinflammatory cytokines, chemokines and IgE.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
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 · GK1LYB375A · 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.
No statement of the main limit is recorded.
The four opening statements run to 89 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.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
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.
Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268)
✗ The study did not show it
Who was studied
NCT03587805
How many people
1672
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Annualised Asthma Exacerbation Rate (AAER) up to Week 52
✗ The study did not show it
Who was studied
NCT02161757
How many people
1207
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Annualised Asthma Exacerbation Rate (AAER) up to Week 52
✗ The study did not show it
Who was studied
NCT02194699
How many people
856
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
✗ The study did not show it
Who was studied
NCT03131648
How many people
802
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16.
✗ The study did not show it
Who was studied
NCT03160885
How many people
794
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Annual Asthma Exacerbation Rate (AER)
✗ The study did not show it
Who was studied
NCT01402986
How many people
689
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
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. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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 healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.3 registered measures of this kind.
■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 dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□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 would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
time to reach maximum observed serum concentration
maximum observed serum concentration
time to maximum concentration
Meaningful
Things that change how a life goes, not only a number.
No registered study measured anything of this kind.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (16)
safety
annual asthma exacerbation rate
terminal phase elimination half life
predicted forced vital capacity at week 52
terminal elimination half life
adverse events and serious adverse events
clinical laboratory abnormalities
investigator s global assessment of 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
ctrough
cmax
tmax
adverse events
retrieved devices assessable tissue
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
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.
ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids.
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.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness of ADBRY have not been established in pediatric patients younger than 12 years of age.”
US prescribing information · d8020b69-3001-44e2-9b5d-5f93d9aaf6e1 · read 2026-08-30
On older people, the label states: “Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects [see Clinical Pharmacology (12.3) ].”
US prescribing information · d8020b69-3001-44e2-9b5d-5f93d9aaf6e1 · read 2026-08-30
On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADBRY during pregnancy.”
US prescribing information · d8020b69-3001-44e2-9b5d-5f93d9aaf6e1 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of tralokinumab-ldrm in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · d8020b69-3001-44e2-9b5d-5f93d9aaf6e1 · read 2026-08-30
Where the result stopped carrying
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.
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 (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. 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
Injection
✎ 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
Sold as injectable, injection, solution, given by the injection, subcutaneous route.
✎ 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.
What it would be like to take∅Nothing found in the sources checked
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.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
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.
Tralokinumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1625 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
dermatitis atopic — 556 reaction mentions
pruritus — 252 reaction mentions
rash — 185 reaction mentions
eczema — 121 reaction mentions
injection site pain — 114 reaction mentions
injection site erythema — 93 reaction mentions
erythema — 85 reaction mentions
injection site swelling — 74 reaction mentions
injection site pruritus — 73 reaction mentions
dry skin — 72 reaction mentions
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
Injection
✎ 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
2 products list this as an active ingredient in the United States drug directory. 2 of them contain it and nothing else.
FDA National Drug Code directory · 50222-346 · read 2026-08-29
They are sold as injection, solution, taken subcutaneous.
FDA National Drug Code directory · 50222-346 · read 2026-08-29
The regulator's established pharmacologic class for it is interleukin-13 antagonist [epc] and interleukin-13 antagonists [moa].
FDA National Drug Code directory · 50222-346 · 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 · d8020b69-3001-44e2-9b5d-5f93d9aaf6e1 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · d8020b69-3001-44e2-9b5d-5f93d9aaf6e1 · read 2026-08-29
Adbry is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS ADBRY is a clear to opalescent, colorless to pale yellow solution available as: Injection: 150 mg/mL solution in a single-dose prefilled syringe with needle guard Injection: 300 mg/2 mL solu…, recorded as fda label in effect 2025-12-17 in the United States.
US prescribing information · d8020b69-3001-44e2-9b5d-5f93d9aaf6e1 · read 2026-08-30
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 Tralokinumab 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
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 Tralokinumab 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.
Where else this substance is registered
FDA substance identifier (UNII)
GK1LYB375A
CAS registry number
1044515-88-9
ChEMBL
CHEMBL1743081
WHO international nonproprietary name list entry
9235
RxNorm concept
2589225
EMA substance identifier
100000175358
DrugBank
DB12169
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
The identity record classes it as Monoclonal Antibody (mAb).
✓ Passed
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 BLA761180, approved 20211227 to LEO PHARMA AS.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (10)
Q1
What did Tralokinumab's largest trial (1672 people) and its longest (13 years) measure?
1672 people in Tralokinumab's largest registered study, 13 years in its longest registered window, measuring Change From Baseline in Doubling Concentration of Methacholine at Day 28. ClinicalTrials.gov · 2026-09-01
12 phase3, 10 phase2, 6 phase1, 3 na or unstated, 2 phase4; NCT03358693; 2029-12-31; no ageing endpoint recorded. Last human test completed 2026, NCT05388760.
Interpretation These counts include studies where Tralokinumab 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
phase3
12
phase2
10
phase1
6
na or unstated
3
phase4
2
Last recorded human testNCT05388760
2026-04-29
recorded 2026-09-01 · last checked 2026-09-04
Q2
Tralokinumab was tested only in human — what did it show?
Change From Baseline in Doubling Concentration of Methacholine at Day 28 — the recorded outcome words.
Show the evidence
humanNCT00640016
biomarker; Change From Baseline in Doubling Concentration of Methacholine at Day 28; 33
recorded 2026-09-01 · last checked 2026-09-04
Q3
5 of Tralokinumab's trials stopped: futility/efficacy, accrual/recruitment, other?
futility/efficacy (1), accrual/recruitment (2) and other (2): Tralokinumab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"The study was terminated prematurely by the sponsor due to slow recruitment."; 5 of 33 registered studies
Show the evidence
Trial
NCT00640016
terminated; "The study was terminated prematurely by the sponsor due to slow recruitment."
NCT00974675
terminated; "Study recruitment was terminated before the planned number of subjects was enrolled in CAT-354 10 mg/kg group due to the slow recruitment rate."
NCT01629667
terminated; "Early termination of the study due to lack of efficacy."
NCT02902809
terminated; "The study was terminated due to the discontinuation of the tralokinumab asthma program (as per the results of the Phase III study \[D2210C00008\])"
NCT06773455
terminated; "Principal Investigator retired"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Tralokinumab used CAT-354 150 mg (intravenous) — over how long?
14 recorded entries; human; intravenous, subcutaneous; also "CAT-354 150 mg (subcutaneous)", "CAT-354 300 mg (subcutaneous)", "CAT-354 1 mg/kg"
Show the evidence
human
NCT00638989
intravenous; CAT-354 150 mg (intravenous)
NCT00638989
subcutaneous; CAT-354 150 mg (subcutaneous)
NCT00638989
subcutaneous; CAT-354 300 mg (subcutaneous)
NCT00640016
CAT-354 1 mg/kg
NCT00640016
CAT-354 5 mg/kg
NCT00640016
CAT-354 10 mg/kg
8 more recorded rows
humanNCT00873860
CAT-354 150 mg
humanNCT00873860
CAT-354 300 mg
humanNCT00873860
CAT-354 600 mg
humanNCT00974675
CAT-354 1mg/kg
humanNCT00974675
CAT-354 10mg/kg
humanNCT01402986
Tralokinumab 300 mg, Q2W
humanNCT01402986
Tralokinumab 300 mg, Q2/4W
humanNCT01592396
Tralokinumab 300 mg
recorded 2026-09-01 · last checked 2026-09-04
Q5
Could one person measure Tralokinumab's effect on safety?
Safety: measured in Tralokinumab's trials.
Interpretation safety is the recorded endpoint.
Show the evidence
biomarkers
safety; 2026-09-01
annual asthma exacerbation rate; 2026-09-01
time to reach maximum observed serum concentration; 2026-09-01
maximum observed serum concentration; 2026-09-01
terminal phase elimination half life; 2026-09-01
predicted forced vital capacity at week 52; 2026-09-01
13 more recorded rows
biomarkers
time to maximum concentration; 2026-09-01
biomarkers
terminal elimination half life; 2026-09-01
biomarkers
adverse events and serious adverse events; 2026-09-01
biomarkers
clinical laboratory abnormalities; 2026-09-01
biomarkers
investigator s global assessment of 0 or 1 at week 16; 2026-09-01
biomarkers
changes of molecular profiles over time; 2026-09-01
biomarkers
changes of molecular profiles associated treatment; 2026-09-01
biomarkers
changes of molecular profiles associated treatment response; 2026-09-01
biomarkers
ctrough; 2026-09-01
biomarkers
cmax; 2026-09-01
biomarkers
tmax; 2026-09-01
biomarkers
adverse events; 2026-09-01
biomarkers
retrieved devices assessable tissue; 2026-09-01
half life
2026-09-04; halfLife; 2025-12-17
human trials at or under30
12
smallest human trial
7; NCT06773455; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; TERMINATED
Q6
Which of adverse events, adverse events and serious adverse events and annual asthma exacerbation rate did Tralokinumab's trials measure?
adverse events, adverse events and serious adverse events and annual asthma exacerbation rate lead 19 outcome terms across Tralokinumab's trials. ClinicalTrials.gov · 2026-09-01
maximum observed serum concentration, terminal phase elimination half life, predicted forced vital capacity at week 52, time to maximum concentration, terminal elimination half life and adverse events and serious adverse events follow.
Show the evidence
safety
1
annual asthma exacerbation rate
1
time to reach maximum observed serum concentration
1
maximum observed serum concentration
1
terminal phase elimination half life
1
predicted forced vital capacity at week 52
1
13 more recorded rows
time to maximum concentration
1
terminal elimination half life
1
adverse events and serious adverse events
1
clinical laboratory abnormalities
1
investigator s global assessment of 0 or 1 at week 16
1
changes of molecular profiles over time
1
changes of molecular profiles associated treatment
1
changes of molecular profiles associated treatment response
1
ctrough
1
cmax
1
tmax
1
adverse events
1
retrieved devices assessable tissue
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Tralokinumab's 4 ongoing trials reports first?
Changes of molecular profiles over time; Prevalence of Major Structural Birth Defects; latest 2035-09-30
Show the evidence
Trial
NCT03358693
"Molecular Signatures in Inflammatory Skin Disease"; n 300; "Changes of molecular profiles over time"; 2029-12-31
NCT05938478
"Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT"; n 900; "Prevalence of Major Structural Birth Defects"; 2035-09-30
NCT07352566
"Utilization of a Microdevice for Psoriasis and Atopic Dermatitis"; n 10; "Number of participants with adverse events"; 2030-06-01
NCT07444801
"Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact"; n 30; "Genital-Numerical Rating Scale"; 2028-06-30
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which 3 trials of Tralokinumab posted no result?
Posted no result
3 of 3 completed trials
Registrations
NCT01093040, NCT03556592 and NCT04556461
Completion dates
oldest 2010-10; newest 2023-03-31
Show the evidence
Trial
NCT01093040
2010-10
NCT03556592
2020-06-20
NCT04556461
2023-03-31
Q9
At the median, Tralokinumab's trials enrolled 136 people — anything larger?
Median enrolment
136
Largest enrolment
1672
Registered trials counted
33
Q10
What do 1625 spontaneous reports say about Tralokinumab — 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.
Tralokinumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1625 reaction mentions were counted: dermatitis atopic 556; pruritus 252; rash 185; eczema 121. open-targets-adr · CHEMBL1743081 · 2026-06-24
Show the evidence
dermatitis atopic
556
pruritus
252
rash
185
eczema
121
injection site pain
114
injection site erythema
93
4 more recorded rows
erythema
85
injection site swelling
74
injection site pruritus
73
dry skin
72
recorded 2026-06-24 · last checked 2026-09-04
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