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NCT03526861 · ClinicalTrials.gov registry record · Phase 3
Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
A Phase 3 study of Atopic Dermatitis, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 301
- Enrollment target
- 20
- Study locations
NCT03526861: Completed Phase 3 study of Atopic Dermatitis, sponsored by LEO Pharma.
NCT03526861 is a Phase 3 study of Atopic Dermatitis that has completed, run by LEO Pharma. The registered enrollment target is 301 participants, below the 607-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03526861, a Phase 3 study of Atopic Dermatitis, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 301 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary objective: To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD. Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo. To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD.
Primary Outcome
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Conditions Studied
Interventions
- DRUG Placebos
- DRUG Tralokinumab
Study Locations (20)
California
- Leo Pharma Investigational Site - Fountain Valley
- LEO Pharma Investigational Site - Los Angeles
- LEO Pharma Investigational Site - San Francisco
- LEO Pharma Investigational Site - Stanford
Michigan
- LEO Pharma Investigational Site - Ann Arbor
- LEO Pharma Investigational Site - Ypsilanti
New York
- LEO Pharma Investigational Site - Corning
- Leo Pharma Investigational Site - New York
Alabama
- LEO Pharma Investigational Site - Birmingham
Arkansas
- LEO Pharma Investigational Site - Fort Smith
Connecticut
- LEO Pharma Investigational Site - New Haven
Florida
- LEO Pharma Investigational Site - Miami
Georgia
- Leo Pharma Investigational Site - Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2018-06-19 |
| Est. Completion | 2021-03-16 |
| Phase | Phase 3 |
What the finished NCT03526861 record still lists
NCT03526861 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, below the 607-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebos is the first listed.
NCT03526861 names 20 study sites across 15 states, led by California, Michigan, New York.
Frequently Asked Questions
What is clinical trial NCT03526861 about?
NCT03526861 is a clinical study titled "Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).". Primary objective: To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD. Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itc...
What is the current status of trial NCT03526861?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 301 participants. The study started on 2018-06-19. Estimated completion is 2021-03-16.
What conditions does trial NCT03526861 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT03526861?
The interventions under investigation include: Placebos (DRUG), Tralokinumab (DRUG).
Who is sponsoring clinical trial NCT03526861?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03526861 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atopic Dermatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03526861's enrollment target sits among peer trials
301 41st of 150 higher than 110 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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