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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 160 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04202679
The ClinicalTrials.gov registry entry for NCT04202679 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 160 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 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04202679 reports 0 study locations.
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.
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