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NCT05263206PHASE3Recruiting

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

Sanofi

Start Date

2/15/2022

Completion Date

8/25/2027

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.

Detailed Description

Study duration per participant will be up to 44 weeks for both Study A and Study B.

Eligibility Criteria

Age Range: 18 years to 90 years

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.

Interventions

DRUG

Dupilumab

DRUG

Placebo

DRUG

Fexofenadine (loratadine if not available)

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Conditions

Pruritus

Locations

Kern Allergy and Medical Research- Site Number : 8400016

Bakersfield, California 93301

United States

Modena Allergy + Asthma- Site Number : 8400038

La Jolla, California 92037

United States

FoxHall Dermatology- Site Number : 8400042

Washington D.C., District of Columbia 20016

United States

Palm Harbor Dermatology- Site Number : 8400024

Belleair, Florida 32756

United States

University of Miami Hospital- Site Number : 8400011

Miami, Florida 33136

United States

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

Macon, Georgia 31217

United States

Aeroallergy Research Laboratory- Site Number : 8400036

Savannah, Georgia 31406

United States

Dawes Fretzin Clinical Research- Site Number : 8400007

Indianapolis, Indiana 46256

United States

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

Louisville, Kentucky 40241

United States

Tulane University School of Medicine- Site Number : 8400045

New Orleans, Louisiana 70112

United States

Johns Hopkins Hospital- Site Number : 8400020

Baltimore, Maryland 21287

United States

The Asthma and Allergy Center- Site Number : 8400014

Bellevue, Nebraska 68123

United States

Mount Sinai - Union Square- Site Number : 8400034

New York, New York 10003

United States

AXIS Clinicals - Fargo- Site Number : 8400037

Fargo, North Dakota 58103

United States

Optima Research - Boardman- Site Number : 8400039

Boardman, Ohio 44512

United States

Columbia Dermatology & Aesthetics- Site Number : 8400047

Columbia, South Carolina 29212

United States

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

North Charleston, South Carolina 29420

United States

Complete Dermatology - Sugar Land- Site Number : 8400046

Sugar Land, Texas 77479

United States

Investigational Site Number : 0320004

Rosario, Santa Fe Province 2000

Argentina

Investigational Site Number : 0320008

Rosario, Santa Fe Province 2000

Argentina

Investigational Site Number : 0320005

Buenos Aires, 1012

Argentina

Investigational Site Number : 0320001

Buenos Aires, 1023

Argentina

Investigational Site Number : 0320006

Buenos Aires, 1055

Argentina

Investigational Site Number : 0320007

Buenos Aires, 1061

Argentina

Investigational Site Number : 0320002

Buenos Aires, 1121

Argentina

Investigational Site Number : 0320003

Buenos Aires, 1414

Argentina

Investigational Site Number : 1240001

Calgary, Alberta T2G 1B1

Canada

Investigational Site Number : 1240008

Edmonton, Alberta T6G 1C3

Canada

Investigational Site Number : 1240002

London, Ontario L6A 2C2

Canada

Investigational Site Number : 1240003

Markham, Ontario L3P 1X2

Canada

Investigational Site Number : 1240006

Toronto, Ontario M4C 1L1

Canada

Investigational Site Number : 1240005

Montreal, Quebec H4A 3T2

Canada

Investigational Site Number : 1240004

Verdun, Quebec H4G 2L8

Canada

Investigational Site Number : 1560003

Beijing, 100191

China

Investigational Site Number : 1560004

Chengdu, 610041

China

Investigational Site Number : 1560009

Chongqing, 400016

China

Investigational Site Number : 1560006

Guangzhou, 510018

China

Investigational Site Number : 1560005

Guangzhou, 510080

China

Investigational Site Number : 1560002

Hangzhou, 310006

China

Investigational Site Number : 1560001

Shanghai, 200040

China

Investigational Site Number : 1560011

Suzhou, 215006

China

Investigational Site Number : 1560008

Wuhan, 430022

China

Investigational Site Number : 2500001

Brest, 29200

France

Investigational Site Number : 2500003

Nice, 06202

France

Investigational Site Number : 2500004

Reims, 51100

France

Investigational Site Number : 2760005

Bad Bentheim, 48455

Germany

Investigational Site Number : 2760002

Berlin, 12203

Germany

Investigational Site Number : 2760004

Frankfurt, 60590

Germany

Investigational Site Number : 2760003

Mainz, 55131

Germany

Investigational Site Number : 2760001

Münster, 48149

Germany

Investigational Site Number : 3480001

Budapest, 1036

Hungary

Investigational Site Number : 3480009

Budapest, 1066

Hungary

Investigational Site Number : 3480005

Debrecen, 4031

Hungary

Investigational Site Number : 3480010

Gyula, 5700

Hungary

Investigational Site Number : 3480003

Szeged, 6720

Hungary

Investigational Site Number : 3480011

Székesfehérvár, 8000

Hungary

Investigational Site Number : 3480002

Zalaegerszeg, 8900

Hungary

Azienda Ospedaliero-Universitaria di Ferrara-Site Number : 3800007

Cona, Ferrara 44124

Italy

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

Florence, Firenze 50125

Italy

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

Milan, Milano 20122

Italy

Investigational Site Number : 3800002

Rozzano, Milano 20089

Italy

Investigational Site Number : 3800006

Naples, Napoli 80131

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001

Rome, Roma 00168

Italy

Azienda Ospedaliero Universitaria delle Marche-Site Number : 3800004

Ancona, 60126

Italy

Investigational Site Number : 3920007

Urayasu, Chiba 279-0011

Japan

Investigational Site Number : 3920003

Obihiro, Hokkaido 080-0013

Japan

Investigational Site Number : 3920006

Sapporo, Hokkaido 060-0063

Japan

Investigational Site Number : 3920004

Habikino, Osaka 583-8588

Japan

Investigational Site Number : 3920002

Sakai, Osaka 593-8324

Japan

Investigational Site Number : 3920005

Izumo, Shimane 693-8501

Japan

Investigational Site Number : 3920001

Tachikawa, Tokyo 190-0023

Japan

Investigational Site Number : 6160001

Krakow, Lesser Poland Voivodeship 30-033

Poland

Investigational Site Number : 6160007

Wroclaw, Lower Silesian Voivodeship 50-566

Poland

Investigational Site Number : 6160003

Wroclaw, Lower Silesian Voivodeship 51-318

Poland

Investigational Site Number : 6160003

Wroclaw, Lower Silesian Voivodeship 51-503

Poland

Investigational Site Number : 6160008

Warsaw, Masovian Voivodeship 01-142

Poland

Investigational Site Number : 6160005

Warsaw, Masovian Voivodeship 02-172

Poland

Investigational Site Number : 4100003

Busan, Busan 49241

South Korea

Investigational Site Number : 4100004

Ansan-si, Gyeonggi-do 15355

South Korea

Investigational Site Number : 4100005

Seoul, Seoul-teukbyeolsi 03080

South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi 03722

South Korea

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi 05030

South Korea

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi 07441

South Korea

Investigational Site Number : 4100007

Seoul, Seoul-teukbyeolsi 07804

South Korea

Investigational Site Number : 7240003

Barcelona, Barcelona [Barcelona] 08003

Spain

Investigational Site Number : 7240006

Barcelona, Catalunya [Cataluña] 08041

Spain

Investigational Site Number : 7240001

Pontevedra, Pontevedra [Pontevedra] 36002

Spain

Investigational Site Number : 7240005

Alicante, 03010

Spain

Investigational Site Number : 7240004

Córdoba, 14004

Spain

Investigational Site Number : 1580003

Kaohsiung City, 833

Taiwan

Investigational Site Number : 1580004

New Taipei City, 235

Taiwan

Investigational Site Number : 1580001

Taipei, 100

Taiwan

Investigational Site Number : 1580002

Taoyuan City, 333

Taiwan