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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 is a Phase 3 study of Neurodermatitis that has completed, run by Sanofi. The registered enrollment target is 151 participants. The trial reports 20 study locations across 14 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04183335
The ClinicalTrials.gov registry entry for NCT04183335 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.