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Clinical Trials in China / NCT05263206
Recruiting Phase 3

Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)

NCT05263206 · tracked via the Priya Life Science China tracker
Sponsor
Sanofi
Phase
Phase 3
Started
2022-02-15
Last updated
2026-07-06

Condition(s) studied

Pruritus

Investigational drug(s) / intervention(s)

Dupilumab →PlaceboFexofenadine (loratadine if not available)

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

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the informed consent. * Participants with chronic pruritus for at least 6 months before the screening visit. * Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (excluding chronic pruritus secondary to dermatological or systemic conditions, of neuropathic or psychogenic origin or secondary to drugs). * Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk. * History of insufficient control of the chronic pruritus with prior treatment. * Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency). * Participants must have a history of severe itch and a worst itch score of ≥7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient Global Impression of Severity (PGIS) of pruritus scored "severe" at screening. * Participants must have an average worst itch score of ≥7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS. * Participants scored "severe" in the PGIS of pruritus on Day 1. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study. * Patients with active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis, unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent. * Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the screening visit. * HIV infection. * Severe renal failure (dialysis). * Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the run-in visit. * Known or suspected immunodeficiency. * Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin. * History of hypersensitivity or intolerance to non-sedative antihistamines. * Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcome measure(s)

Trial sites (93)

FacilityCityRegionStatus
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 →

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Official registry record

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