Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
Condition(s) studied
Investigational drug(s) / intervention(s)
Dupilumab: Injection solution subcutaneous
Placebo: Injection solution SC
Fexofenadine (loratadine if not available): Tablet or capsule Oral
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.
Eligibility
Primary outcome measure(s)
- Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 24 — Baseline to Week 24
WI-NRS is a patient reported outcome (PRO) comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). - Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12 — Baseline to Week 12
WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
Trial sites (93)
| 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.
On this site
📄 Dupixent (dupilumab) drug profile →More Sanofi trials in Italy
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 Italy