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NCT03989349 · ClinicalTrials.gov registry record · Phase 3
Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
A Phase 3 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 787
- Enrollment target
NCT03989349: Completed Phase 3 study, sponsored by Galderma R&D.
NCT03989349 is a Phase 3 study that has completed, run by Galderma R&D. The registered enrollment target is 787 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03989349, a Phase 3 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 787 participants
- Enrollment target
Study Summary
The main purpose of the study was to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.
Primary Outcome
IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of atopic dermatitis (AD) and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week
Interventions
- DRUG Placebo
- DRUG Nemolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 787 participants |
| Start Date | 2019-06-30 |
| Est. Completion | 2022-09-26 |
| Phase | Phase 3 |
What the finished NCT03989349 record still lists
NCT03989349 is an interventional study that assigns participants to a tested intervention. The registered 787 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03989349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03989349 about?
NCT03989349 is a clinical study titled "Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis". The main purpose of the study was to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.
What is the current status of trial NCT03989349?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 787 participants. The study started on 2019-06-30. Estimated completion is 2022-09-26.
What interventions are being tested in trial NCT03989349?
The interventions under investigation include: Placebo (DRUG), Nemolizumab (DRUG).
Who is sponsoring clinical trial NCT03989349?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03989349's enrollment target sits among peer trials
787 431st of 2000 higher than 1,570 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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