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NCT05958407 · ClinicalTrials.gov registry record · Phase 3
A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy
A Phase 3 study of Atopic Dermatitis and Atopic Hand Eczema, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 235
- Enrollment target
- 20
- Study locations
NCT05958407: Completed Phase 3 study of Atopic Dermatitis and Atopic Hand Eczema, sponsored by LEO Pharma.
NCT05958407 is a Phase 3 study of Atopic Dermatitis and Atopic Hand Eczema that has completed, run by LEO Pharma. The registered enrollment target is 235 participants, below the 608-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05958407, a Phase 3 study of Atopic Dermatitis and Atopic Hand Eczema, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 235 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life. The trial will last for up to 40 weeks. There will be up to 15 visits, 3 of which will be conducted by phone. The first part of the trial is called a screening period and will last up to 4 weeks. For the first 16 weeks after screening, trial participants will receive either tralokinumab or dummy injections every two weeks. After the first 16 weeks, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. The last part of the trial is a period of 4 weeks after the end of treatment period, where trial participants are off the drug for safety follow-up.
Primary Outcome
IGA-AHE: The Investigator's Global Assessment for atopic hand eczema (IGA-AHE) is an instrument to rate the severity of the subject's AHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tralokinumab
Study Locations (20)
California
- LEO Pharma Investigational Site - Fountain Valley
- LEO Pharma Investigational Site - Los Angeles
- LEO Pharma Investigational Site - Sacramento
Michigan
- LEO Pharma Investigational Site - Caledonia
- LEO Pharma Investigational Site - Detroit
New York
- LEO Pharma Investigational Site - Cortland
- LEO Pharma Investigational Site - New York
Oregon
- LEO Pharma Investigational Site - Portland
- LEO Pharma Investigational Site - Portland
Alabama
- LEO Pharma Investigational Site - Birmingham
Arkansas
- LEO Pharma Investigational Site - Fort Smith
Connecticut
- LEO Pharma Investigational Site - Farmington
Florida
- LEO Pharma Investigational Site - Hialeah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2023-08-28 |
| Est. Completion | 2025-09-22 |
| Phase | Phase 3 |
What the finished NCT05958407 record still lists
NCT05958407 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (61% lower).
The record links to 2 conditions, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05958407 names 20 study sites across 15 states, led by California, Michigan, New York.
Frequently Asked Questions
What is clinical trial NCT05958407 about?
NCT05958407 is a clinical study titled "A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moderate-to-severe Atopic Hand Eczema Who Are Candidates for Systemic Therapy". The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quali...
What is the current status of trial NCT05958407?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2023-08-28. Estimated completion is 2025-09-22.
What conditions does trial NCT05958407 study?
This clinical trial studies the following conditions: Atopic Dermatitis, Atopic Hand Eczema.
What interventions are being tested in trial NCT05958407?
The interventions under investigation include: Placebo (DRUG), Tralokinumab (DRUG).
Who is sponsoring clinical trial NCT05958407?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05958407 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
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Where NCT05958407's enrollment target sits among peer trials
235 49th of 150 higher than 102 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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