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NCT04501679 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
A Phase 3 study of Prurigo Nodularis, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 274
- Enrollment target
- 20
- Study locations
NCT04501679: Completed Phase 3 study of Prurigo Nodularis, sponsored by Galderma R&D.
NCT04501679 is a Phase 3 study of Prurigo Nodularis that has completed, run by Galderma R&D. The registered enrollment target is 274 participants, above the 210-participant average among 14 other Prurigo Nodularis trials with a reported enrollment target (30% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04501679, a Phase 3 study of Prurigo Nodularis, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 274 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (\>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.
Primary Outcome
The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window e
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nemolizumab
Study Locations (20)
Florida
- Galderma Investigational Site - Aventura
- Galderma Investigational Site - Miami
- Galderma Investigational Site - North Miami Beach
- Galderma Investigational Site - Ormond Beach
Texas
- Galderma Investigational Site - Dallas
- Galderma Investigational Site - Dripping Springs
- Galderma Investigational Site - Pflugerville
California
- Galderma Investigational Site - Fountain Valley
- Galderma Investigational Site - San Diego
Ohio
- Galderma Investigational Site - Cincinnati
- Galderma Investigational Site - Dublin
District of Columbia
- Galderma Investigational Site - Washington D.C.
Illinois
- Galderma Investigational Site - Chicago
Indiana
- Galderma Investigational Site - Indianapolis
Kentucky
- Galderma Investigational Site - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2020-08-11 |
| Est. Completion | 2022-03-31 |
| Phase | Phase 3 |
What the finished NCT04501679 record still lists
NCT04501679 is an interventional study that assigns participants to a tested intervention. The registered 274 participants enrollment target is mid-sized for trials with a published cap, above the 210-participant average among 14 other Prurigo Nodularis trials with a reported enrollment target (30% higher).
The record links to 1 condition, with Prurigo Nodularis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04501679 names 20 study sites across 13 states, led by Florida, Texas, California.
Frequently Asked Questions
What is clinical trial NCT04501679 about?
NCT04501679 is a clinical study titled "A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)". The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (\>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.
What is the current status of trial NCT04501679?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 274 participants. The study started on 2020-08-11. Estimated completion is 2022-03-31.
What conditions does trial NCT04501679 study?
This clinical trial studies the following conditions: Prurigo Nodularis.
What interventions are being tested in trial NCT04501679?
The interventions under investigation include: Placebo (DRUG), Nemolizumab (DRUG).
Who is sponsoring clinical trial NCT04501679?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04501679 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prurigo Nodularis
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 NCT04501679's enrollment target sits among peer trials
274 6th of 14 higher than 9 of 14 other Prurigo Nodularis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prurigo Nodularis 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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