12 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16Primary· At Week 16
IGA is an instrument used in clinical trials to rate the severity of the participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)
Group
Value
95% CI
Tralokinumab Subcutaneous Dosing by an Autoinjector
28.7
21.7 – 36.8
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16Primary· At Week 16
Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition
Group
Value
95% CI
Tralokinumab Subcutaneous Dosing by an Autoinjector
43.4
35.3 – 51.8
Number of Treatment-emergent Adverse Events (AEs) From Baseline to Week 16Secondary· From Week 0 to Week 16
An AE will be considered treatment emergent if it started after the first injection of trial drug
Group
Value
95% CI
Tralokinumab Subcutaneous Dosing by an Autoinjector
86
Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16Secondary· From Week 0 to Week 16
Serum samples for determination of presence or absence of ADA will be analysed using a validated bioanalytical method
Group
Value
95% CI
Tralokinumab Subcutaneous Dosing by an Autoinjector
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Initial Treatment Period: Week 0 to week 16, Safety Follow- Up Period: Week 16 to Week 20..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Tralokinumab+TCS Initial Treatment Period Week 0 to Week 16
The purpose of this trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (SC) injection by an autoinjector in adults and adolescents (age 12 to 17 years) with moderate-to-severe atopic dermatitis (AD).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
· Phase 4
· not yet recruiting
NCT05958407 — A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Ecze
· Phase 3
· completed
NCT05938478 — Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
· recruiting
NCT05388760 — Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Tria
· Phase 2
· active not recruiting
NCT04587453 — Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis
· Phase 3
· completed
Other recruiting trials for Atopic Dermatitis
Currently open trials in the same condition.
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· recruiting
NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants
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· recruiting
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Trials by the same sponsor.
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· Phase 3
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LEO Pharma
Last refreshed: 11 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05194540.