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NCT04202679 · ClinicalTrials.gov registry record · Phase 3
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
NCT04202679: Completed Phase 3 study, sponsored by Sanofi.
NCT04202679 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 160 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04202679, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable. Secondary Objectives: To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapy or when those therapies are not advisable. To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.
Primary Outcome
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 12 is reported in this outcome measure.
Interventions
- DRUG Placebo
- DRUG Dupilumab SAR231893
- DRUG Topical calcineurin inhibitors
- DRUG Moisturizers
- DRUG Low to medium potent topical corticosteroids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2020-01-16 |
| Est. Completion | 2021-11-22 |
| Phase | Phase 3 |
What the finished NCT04202679 record still lists
NCT04202679 is an interventional study that assigns participants to a tested intervention. The registered 160 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 (79% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04202679 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04202679 about?
NCT04202679 is a clinical study titled "Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)". Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable. Secondary Objectives: To demonstrate the efficacy of dupilumab on additional...
What is the current status of trial NCT04202679?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2020-01-16. Estimated completion is 2021-11-22.
What interventions are being tested in trial NCT04202679?
The interventions under investigation include: Placebo (DRUG), Dupilumab SAR231893 (DRUG), Topical calcineurin inhibitors (DRUG), Moisturizers (DRUG), Low to medium potent topical corticosteroids (DRUG).
Who is sponsoring clinical trial NCT04202679?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04202679's enrollment target sits among peer trials
160 1479th of 2000 higher than 500 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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