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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03526861
The ClinicalTrials.gov registry entry for NCT03526861 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 607-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (50% lower). The listed sponsor is LEO Pharma, which has 65 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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