Condition: Pruritus · Sponsor: Sanofi
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.
This description comes directly from the study's public registry record.
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| Kern Allergy and Medical Research- Site Number : 8400016 | Bakersfield, California, United States | Completed |
| Modena Allergy + Asthma- Site Number : 8400038 | La Jolla, California, United States | Recruiting |
| FoxHall Dermatology- Site Number : 8400042 | Washington D.C., District of Columbia, United States | Recruiting |
| Palm Harbor Dermatology- Site Number : 8400024 | Belleair, Florida, United States | Recruiting |
| University of Miami Hospital- Site Number : 8400011 | Miami, Florida, United States | Recruiting |
| Skin Care Physicians of Georgia - Macon- Site Number : 8400030 | Macon, Georgia, United States | Recruiting |
| Aeroallergy Research Laboratory- Site Number : 8400036 | Savannah, Georgia, United States | Recruiting |
| Dawes Fretzin Clinical Research- Site Number : 8400007 | Indianapolis, Indiana, United States | Recruiting |
| Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031 | Louisville, Kentucky, United States | Recruiting |
| Tulane University School of Medicine- Site Number : 8400045 | New Orleans, Louisiana, United States | Recruiting |
| Johns Hopkins Hospital- Site Number : 8400020 | Baltimore, Maryland, United States | Recruiting |
| The Asthma and Allergy Center- Site Number : 8400014 | Bellevue, Nebraska, United States | Recruiting |
+ 81 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05263206