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NCT05052983 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis
A Phase 3 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 34
- Enrollment target
NCT05052983: Completed Phase 3 study, sponsored by Galderma R&D.
NCT05052983 is a Phase 3 study that has completed, run by Galderma R&D. The registered enrollment target is 34 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05052983, a Phase 3 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 34 participants
- Enrollment target
Study Summary
The main objective of this study is to assess the long-term durability of response over a 24-week period following withdrawal of nemolizumab in participants with prurigo nodularis (PN) who previously responded to treatment in the Long-term-Extension (LTE) study RD.06.SPR.202699 (NCT05052983). The secondary objective of this study is to assess the safety of nemolizumab compared to placebo over a 24-week period in participants with PN who previously responded to treatment in the LTE study.
Primary Outcome
Time from baseline to relapse, defined as meeting at least 1 of the following criteria. 1. Increase in (weekly average of the) PP NRS score \>=4 points from baseline 2. Increase in IGA score \>=2 points from baseline. Time to relapse was censored at the last assessment of IGA and PP NRS prior to treatment discontinuation or use of prohibited medication
Interventions
- DRUG Placebo
- DRUG Nemolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2022-01-24 |
| Est. Completion | 2023-09-11 |
| Phase | Phase 3 |
What the finished NCT05052983 record still lists
NCT05052983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05052983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05052983 about?
NCT05052983 is a clinical study titled "A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis". The main objective of this study is to assess the long-term durability of response over a 24-week period following withdrawal of nemolizumab in participants with prurigo nodularis (PN) who previously responded to treatment in the Long-term-Extension (LTE) study RD.06.SPR.202699 (NCT05052983). The se...
What is the current status of trial NCT05052983?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2022-01-24. Estimated completion is 2023-09-11.
What interventions are being tested in trial NCT05052983?
The interventions under investigation include: Placebo (DRUG), Nemolizumab (DRUG).
Who is sponsoring clinical trial NCT05052983?
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 NCT05052983's enrollment target sits among peer trials
34 1905th of 2000 higher than 94 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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