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NCT05263206 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
A Phase 3 study of Pruritus, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 284
- Enrollment target
- 20
- Study locations
NCT05263206 is a Phase 3 study of Pruritus that is actively recruiting participants, run by Sanofi. The registered enrollment target is 284 participants, above the 87-participant average among 12 other Pruritus trials with a reported enrollment target (226% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT05263206, a Phase 3 study of Pruritus, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 284 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO. This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90 years with CPUO. Study B design was to be adapted based on the results of Study A. For both Study A and B, after an up-to-4-week screening period, participants with severe pruritus (worst-itch numerical rating scale \[WI-NRS ≥7) will enter a 4-week run-in period and will be treated with a non-sedative antihistamine and an emollient (moisturizer). Participants with severe pruritus (WI-NRS ≥7) at baseline will be randomized (1:1) to be treated for 24 weeks with either dupilumab or matching placebo in addition to their non-sedative antihistamine and emollient regimen. The treatment period for both study A and B will be followed by a 12-week follow-up period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dupilumab
- DRUG Fexofenadine (loratadine if not available)
Study Locations (20)
California
- Kern Allergy and Medical Research- Site Number : 8400016 - Bakersfield
- Modena Allergy + Asthma- Site Number : 8400038 - La Jolla
Florida
- Palm Harbor Dermatology- Site Number : 8400024 - Belleair
- University of Miami Hospital- Site Number : 8400011 - Miami
Georgia
- Skin Care Physicians of Georgia - Macon- Site Number : 8400030 - Macon
- Aeroallergy Research Laboratory- Site Number : 8400036 - Savannah
South Carolina
- Columbia Dermatology & Aesthetics- Site Number : 8400047 - Columbia
- National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400032 - North Charleston
Santa Fe Province
- Investigational Site Number : 0320004 - Rosario
- Investigational Site Number : 0320008 - Rosario
District of Columbia
- FoxHall Dermatology- Site Number : 8400042 - Washington D.C.
Indiana
- Dawes Fretzin Clinical Research- Site Number : 8400007 - Indianapolis
Kentucky
- Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031 - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 284 participants |
| Start Date | 2022-02-15 |
| Est. Completion | 2027-08-25 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05263206
The ClinicalTrials.gov registry entry for NCT05263206 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 284 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 87-participant average among 12 other Pruritus trials with a reported enrollment target (226% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pruritus appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05263206 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT05263206 about?
NCT05263206 is a clinical study titled "Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)". The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO. This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participan...
What is the current status of trial NCT05263206?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 284 participants. The study started on 2022-02-15. Estimated completion is 2027-08-25.
What conditions does trial NCT05263206 study?
This clinical trial studies the following conditions: Pruritus.
What interventions are being tested in trial NCT05263206?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG), Fexofenadine (loratadine if not available) (DRUG).
Who is sponsoring clinical trial NCT05263206?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05263206 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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