Dupilumab: Injection solution subcutaneous
Placebo: Injection solution SC
Fexofenadine (loratadine if not available): Tablet or capsule Oral
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Kern Allergy and Medical Research- Site Number : 8400016 | Bakersfield | California | Completed |
| Modena Allergy + Asthma- Site Number : 8400038 | La Jolla | California | Recruiting |
| FoxHall Dermatology- Site Number : 8400042 | Washington D.C. | District of Columbia | Recruiting |
| Palm Harbor Dermatology- Site Number : 8400024 | Belleair | Florida | Recruiting |
| University of Miami Hospital- Site Number : 8400011 | Miami | Florida | Recruiting |
| Skin Care Physicians of Georgia - Macon- Site Number : 8400030 | Macon | Georgia | Recruiting |
| Aeroallergy Research Laboratory- Site Number : 8400036 | Savannah | Georgia | Recruiting |
| Dawes Fretzin Clinical Research- Site Number : 8400007 | Indianapolis | Indiana | Recruiting |
| Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031 | Louisville | Kentucky | Recruiting |
| Tulane University School of Medicine- Site Number : 8400045 | New Orleans | Louisiana | Recruiting |
| Johns Hopkins Hospital- Site Number : 8400020 | Baltimore | Maryland | Recruiting |
| The Asthma and Allergy Center- Site Number : 8400014 | Bellevue | Nebraska | Recruiting |
| Mount Sinai - Union Square- Site Number : 8400034 | New York | New York | Recruiting |
| AXIS Clinicals - Fargo- Site Number : 8400037 | Fargo | North Dakota | Recruiting |
| Optima Research - Boardman- Site Number : 8400039 | Boardman | Ohio | Recruiting |
| Columbia Dermatology & Aesthetics- Site Number : 8400047 | Columbia | South Carolina | Recruiting |
| National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400032 | North Charleston | South Carolina | Recruiting |
| Complete Dermatology - Sugar Land- Site Number : 8400046 | Sugar Land | Texas | Recruiting |
| Investigational Site Number : 0320004 | Rosario | Santa Fe Province | Completed |
| Investigational Site Number : 0320008 | Rosario | Santa Fe Province | Recruiting |
| Investigational Site Number : 0320005 | Buenos Aires | Argentina | Recruiting |
| Investigational Site Number : 0320001 | Buenos Aires | Argentina | Completed |
| Investigational Site Number : 0320006 | Buenos Aires | Argentina | Recruiting |
| Investigational Site Number : 0320007 | Buenos Aires | Argentina | Recruiting |
| Investigational Site Number : 0320002 | Buenos Aires | Argentina | Recruiting |
| Investigational Site Number : 0320003 | Buenos Aires | Argentina | Recruiting |
| Investigational Site Number : 1240001 | Calgary | Alberta | Recruiting |
| Investigational Site Number : 1240008 | Edmonton | Alberta | Completed |
| Investigational Site Number : 1240002 | London | Ontario | Recruiting |
| Investigational Site Number : 1240003 | Markham | Ontario | Completed |
| Investigational Site Number : 1240006 | Toronto | Ontario | Recruiting |
| Investigational Site Number : 1240005 | Montreal | Quebec | Completed |
| Investigational Site Number : 1240004 | Verdun | Quebec | Recruiting |
| Investigational Site Number : 1560003 | Beijing | China | Recruiting |
| Investigational Site Number : 1560004 | Chengdu | China | Recruiting |
| Investigational Site Number : 1560009 | Chongqing | China | Recruiting |
| Investigational Site Number : 1560006 | Guangzhou | China | Recruiting |
| Investigational Site Number : 1560005 | Guangzhou | China | Recruiting |
| Investigational Site Number : 1560002 | Hangzhou | China | Recruiting |
| Investigational Site Number : 1560001 | Shanghai | China | Recruiting |
+ 53 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05263206 on ClinicalTrials.gov ↗ ← All trials in China