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NCT04501666 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
A Phase 3 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 286
- Enrollment target
NCT04501666: Completed Phase 3 study, sponsored by Galderma R&D.
NCT04501666 is a Phase 3 study that has completed, run by Galderma R&D. The registered enrollment target is 286 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04501666, a Phase 3 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 286 participants
- Enrollment target
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 the average of 7 consecutive days of data up to the target study day (excluding) and set to missing if less than 4 days of data are available. Analysis
Interventions
- DRUG Placebo
- DRUG Nemolizumab 30 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 286 participants |
| Start Date | 2020-09-11 |
| Est. Completion | 2023-02-21 |
| Phase | Phase 3 |
What the finished NCT04501666 record still lists
NCT04501666 is an interventional study that assigns participants to a tested intervention. The registered 286 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04501666 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04501666 about?
NCT04501666 is a clinical study titled "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 NCT04501666?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 286 participants. The study started on 2020-09-11. Estimated completion is 2023-02-21.
What interventions are being tested in trial NCT04501666?
The interventions under investigation include: Placebo (DRUG), Nemolizumab 30 mg (DRUG).
Who is sponsoring clinical trial NCT04501666?
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 NCT04501666's enrollment target sits among peer trials
286 1182nd of 2000 higher than 816 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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