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RECRUITING

NCT05263206

PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: Master Protocol of Two Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Studies to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Chronic Pruritus of Unknown Origin (CPUO)

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

284

Start Date

2022-02-15

Completion Date

2027-08-25

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Pruritus

Interventions

DRUG

Dupilumab

Injection solution subcutaneous

DRUG

Placebo

Injection solution SC

DRUG

Fexofenadine (loratadine if not available)

Tablet or capsule Oral

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.

Locations (91)

Kern Allergy and Medical Research- Site Number : 8400016

Bakersfield, California, United States

Modena Allergy + Asthma- Site Number : 8400038

La Jolla, California, United States

FoxHall Dermatology- Site Number : 8400042

Washington D.C., District of Columbia, United States

Palm Harbor Dermatology- Site Number : 8400024

Belleair, Florida, United States

University of Miami Hospital- Site Number : 8400011

Miami, Florida, United States

Skin Care Physicians of Georgia - Macon- Site Number : 8400030

Macon, Georgia, United States

Aeroallergy Research Laboratory- Site Number : 8400036

Savannah, Georgia, United States

Dawes Fretzin Clinical Research- Site Number : 8400007

Indianapolis, Indiana, United States

Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031

Louisville, Kentucky, United States

Tulane University School of Medicine- Site Number : 8400045

New Orleans, Louisiana, United States

Johns Hopkins Hospital- Site Number : 8400020

Baltimore, Maryland, United States

The Asthma and Allergy Center- Site Number : 8400014

Bellevue, Nebraska, United States

Mount Sinai - Union Square- Site Number : 8400034

New York, New York, United States

AXIS Clinicals - Fargo- Site Number : 8400037

Fargo, North Dakota, United States

Optima Research - Boardman- Site Number : 8400039

Boardman, Ohio, United States

Columbia Dermatology & Aesthetics- Site Number : 8400047

Columbia, South Carolina, United States

National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400032

North Charleston, South Carolina, United States

Complete Dermatology - Sugar Land- Site Number : 8400046

Sugar Land, Texas, United States

Investigational Site Number : 0320004

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320008

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320005

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320006

Buenos Aires, Argentina

Investigational Site Number : 0320007

Buenos Aires, Argentina

Investigational Site Number : 0320002

Buenos Aires, Argentina

Investigational Site Number : 0320003

Buenos Aires, Argentina

Investigational Site Number : 1240001

Calgary, Alberta, Canada

Investigational Site Number : 1240008

Edmonton, Alberta, Canada

Investigational Site Number : 1240002

London, Ontario, Canada

Investigational Site Number : 1240003

Markham, Ontario, Canada

Investigational Site Number : 1240006

Toronto, Ontario, Canada

Investigational Site Number : 1240005

Montreal, Quebec, Canada

Investigational Site Number : 1240004

Verdun, Quebec, Canada

Investigational Site Number : 1560003

Beijing, China

Investigational Site Number : 1560004

Chengdu, China

Investigational Site Number : 1560009

Chongqing, China

Investigational Site Number : 1560006

Guangzhou, China

Investigational Site Number : 1560005

Guangzhou, China

Investigational Site Number : 1560002

Hangzhou, China

Investigational Site Number : 1560001

Shanghai, China

Investigational Site Number : 1560011

Suzhou, China

Investigational Site Number : 1560008

Wuhan, China

Investigational Site Number : 2500001

Brest, France

Investigational Site Number : 2500003

Nice, France

Investigational Site Number : 2760005

Bad Bentheim, Germany

Investigational Site Number : 2760002

Berlin, Germany

Investigational Site Number : 2760004

Frankfurt, Germany

Investigational Site Number : 2760003

Mainz, Germany

Investigational Site Number : 2760001

Münster, Germany

Investigational Site Number : 3480001

Budapest, Hungary

Investigational Site Number : 3480009

Budapest, Hungary

Investigational Site Number : 3480005

Debrecen, Hungary

Investigational Site Number : 3480003

Szeged, Hungary

Investigational Site Number : 3480011

Székesfehérvár, Hungary

Investigational Site Number : 3480002

Zalaegerszeg, Hungary

Azienda Ospedaliero-Universitaria di Ferrara-Site Number : 3800007

Cona, Ferrara, Italy

AUSL Toscana Centro - Presidio Ospedaliero "Piero Palagi-"Site Number : 3800005

Florence, Firenze, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Site Number : 3800003

Milan, Milano, Italy

Investigational Site Number : 3800002

Rozzano, Milano, Italy

Investigational Site Number : 3800006

Naples, Napoli, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001

Rome, Roma, Italy

Azienda Ospedaliero Universitaria delle Marche-Site Number : 3800004

Ancona, Italy

Investigational Site Number : 3920007

Urayasu, Chiba, Japan

Investigational Site Number : 3920003

Obihiro, Hokkaido, Japan

Investigational Site Number : 3920006

Sapporo, Hokkaido, Japan

Investigational Site Number : 3920004

Habikino, Osaka, Japan

Investigational Site Number : 3920002

Sakai, Osaka, Japan

Investigational Site Number : 3920005

Izumo, Shimane, Japan

Investigational Site Number : 3920001

Tachikawa, Tokyo, Japan

Investigational Site Number : 6160001

Krakow, Lesser Poland Voivodeship, Poland

Investigational Site Number : 6160007

Wroclaw, Lower Silesian Voivodeship, Poland

Investigational Site Number : 6160003

Wroclaw, Lower Silesian Voivodeship, Poland

Investigational Site Number : 6160003

Wroclaw, Lower Silesian Voivodeship, Poland

Investigational Site Number : 6160008

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 6160005

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 4100003

Busan, Busan, South Korea

Investigational Site Number : 4100004

Ansan-si, Gyeonggi-do, South Korea

Investigational Site Number : 4100005