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NCT04183335 · 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 (LIBERTY-PN PRIME)
A Phase 3 study of Neurodermatitis, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 151
- Enrollment target
- 20
- Study locations
NCT04183335: Completed Phase 3 study of Neurodermatitis, sponsored by Sanofi.
NCT04183335 is a Phase 3 study of Neurodermatitis that has completed, run by Sanofi. The registered enrollment target is 151 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04183335, a Phase 3 study of Neurodermatitis, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 151 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapies 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 therapies 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 improvement (reduction) in WI-NRS scores by \>=4 points from Baseline to Week 24 is reported in this outcome measure.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dupilumab SAR231893
- DRUG Topical calcineurin inhibitors
- DRUG Moisturizers
- DRUG Low to medium potent topical corticosteroids
Study Locations (20)
Texas
- Investigational Site Number :8400006 - Bellaire
- Investigational Site Number :8400025 - Houston
- Investigational Site Number :8400002 - Pflugerville
- Investigational Site Number :8400019 - San Antonio
Georgia
- Investigational Site Number :8400004 - Columbus
- Investigational Site Number :8400003 - Newnan
- Investigational Site Number :8400017 - Sandy Springs
Ohio
- Investigational Site Number :8400009 - Athens
- Investigational Site Number :8400001 - Dublin
Arizona
- Investigational Site Number :8400011 - Gilbert
Arkansas
- Investigational Site Number :8400022 - Fort Smith
California
- Investigational Site Number :8400026 - Sacramento
Florida
- Investigational Site Number :8400014 - Miami
Indiana
- Investigational Site Number :8400016 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2019-12-12 |
| Est. Completion | 2022-02-03 |
| Phase | Phase 3 |
What the finished NCT04183335 record still lists
NCT04183335 is an interventional study that assigns participants to a tested intervention. The registered 151 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 (80% lower).
The record links to 1 condition, with Neurodermatitis appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT04183335 names 20 study sites across 14 states, led by Texas, Georgia, Ohio.
Frequently Asked Questions
What is clinical trial NCT04183335 about?
NCT04183335 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 (LIBERTY-PN PRIME)". Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapies or when those therapies are not advisable. Secondary Objectives: To demonstrate the efficacy of dupilumab on addition...
What is the current status of trial NCT04183335?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 151 participants. The study started on 2019-12-12. Estimated completion is 2022-02-03.
What conditions does trial NCT04183335 study?
This clinical trial studies the following conditions: Neurodermatitis.
What interventions are being tested in trial NCT04183335?
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 NCT04183335?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04183335 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04183335's enrollment target sits among peer trials
151 1517th of 2000 higher than 482 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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