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NCT04921345 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis
A Phase 2 study of Moderate-to-Severe Atopic Dermatitis, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
- 20
- Study locations
NCT04921345: Completed Phase 2 study of Moderate-to-Severe Atopic Dermatitis, sponsored by Galderma R&D.
NCT04921345 is a Phase 2 study of Moderate-to-Severe Atopic Dermatitis that has completed, run by Galderma R&D. The registered enrollment target is 105 participants, below the 642-participant average among 4 other Moderate-to-Severe Atopic Dermatitis trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04921345, a Phase 2 study of Moderate-to-Severe Atopic Dermatitis, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the pharmacokinetics (PK), efficacy, and safety of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).
Primary Outcome
Serum concentrations of Nemolizumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Conditions Studied
Interventions
- DRUG Nemolizumab
Study Locations (20)
Other
- Galderma Investigational Site #6218 - Hellerup
- Galderma Investigational Site #6147 - Budapest
- Galderma Investigational Site #5531 - Szeged
- Galderma Investigational Site #5570 - Lodz
- Galderma Investigational Site #6237 - Ostrowiec Świętokrzyski
- Galderma Investigational Site #5495 - Rzeszów
California
- Galderma Investigational Site #8636 - Fountain Valley
- Galderma Investigational Site #9937 - San Diego
- Galderma Investigational Site #9930 - Vista
Michigan
- Galderma Investigational Site #8155 - Troy
- Galderma Investigational Site #8560 - West Bloomfield
New York
- Galderma Investigational Site #8242 - Brooklyn
- Galderma Investigational Site #9938 - New York
Texas
- Galderma Investigational Site #9931 - Beaumont
- Galderma Investigational Site #78218-3128 - San Antonio
Florida
- Galderma Investigational Site #9929 - Coral Gables
Indiana
- Galderma Investigational Site #8142 - Indianapolis
Kentucky
- Galderma Investigational Site #8092 - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2021-06-24 |
| Est. Completion | 2025-04-28 |
| Phase | Phase 2 |
What the finished NCT04921345 record still lists
NCT04921345 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 642-participant average among 4 other Moderate-to-Severe Atopic Dermatitis trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Moderate-to-Severe Atopic Dermatitis appearing as the primary indexed condition, and to 1 intervention - of which Nemolizumab is the first listed.
NCT04921345 names 20 study sites across 10 states, led by Other, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT04921345 about?
NCT04921345 is a clinical study titled "Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis". The purpose of this study is to assess the pharmacokinetics (PK), efficacy, and safety of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).
What is the current status of trial NCT04921345?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2021-06-24. Estimated completion is 2025-04-28.
What conditions does trial NCT04921345 study?
This clinical trial studies the following conditions: Moderate-to-Severe Atopic Dermatitis.
What interventions are being tested in trial NCT04921345?
The interventions under investigation include: Nemolizumab (DRUG).
Who is sponsoring clinical trial NCT04921345?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04921345 being conducted?
This trial has 20 study locations across California, Florida, Indiana, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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