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

NCT05263206 | Recruiting Phase 3 FDA Drug

• 5 other identifiers: EFC16973U1111-1253-98882023-508879-36-002023-508879-362021-004315-76
• Study Type: interventional
• Target: 284
• Locations: 13 countries
• Sites: 91

Brief 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.

Conditions

Pruritus

Outcome Measures

Primary Outcomes (2)

• 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

  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").

  Baseline to Week 24

• Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from 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").

  Baseline to Week 12

Secondary Outcomes (41)

• Study A; Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12

  Baseline to Week 12

• Study A: Proportion of participants who scored "none" or "mild" in Patient Global Impression of Severity (PGIS) of pruritus at Week 24

  Week 24

• Study A: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline over time until Week 24

  Baseline to Week 24

• Study A: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24

  Baseline to Week 24

• Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24

  Baseline to Week 24

Study Arms (2)

Dupilumab

EXPERIMENTAL

Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) on top of non-sedative antihistamine and moisturizer

Drug: Dupilumab; Drug: Fexofenadine (loratadine if not available)

Placebo

PLACEBO COMPARATOR

Loading dose administered SC, followed by SC Q2W on top of non-sedative antihistamine and moisturizer

Drug: Placebo; Drug: Fexofenadine (loratadine if not available)

Interventions

Dupilumab DRUG

Injection solution subcutaneous

Dupilumab

Placebo DRUG

Injection solution SC

Placebo

Fexofenadine (loratadine if not available) DRUG

Tablet or capsule Oral

Dupilumab; Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (91)

Kern Allergy and Medical Research- Site Number : 8400016

Bakersfield, California, 93301, United States

COMPLETED

Modena Allergy + Asthma- Site Number : 8400038

La Jolla, California, 92037, United States

RECRUITING

FoxHall Dermatology- Site Number : 8400042

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Palm Harbor Dermatology- Site Number : 8400024

Belleair, Florida, 32756, United States

RECRUITING

University of Miami Hospital- Site Number : 8400011

Miami, Florida, 33136, United States

RECRUITING

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

Macon, Georgia, 31217, United States

RECRUITING

Aeroallergy Research Laboratory- Site Number : 8400036

Savannah, Georgia, 31406, United States

RECRUITING

Dawes Fretzin Clinical Research- Site Number : 8400007

Indianapolis, Indiana, 46256, United States

RECRUITING

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

Louisville, Kentucky, 40241, United States

RECRUITING

Tulane University School of Medicine- Site Number : 8400045

New Orleans, Louisiana, 70112, United States

RECRUITING

Johns Hopkins Hospital- Site Number : 8400020

Baltimore, Maryland, 21287, United States

RECRUITING

The Asthma and Allergy Center- Site Number : 8400014

Bellevue, Nebraska, 68123, United States

RECRUITING

Mount Sinai - Union Square- Site Number : 8400034

New York, New York, 10003, United States

RECRUITING

AXIS Clinicals - Fargo- Site Number : 8400037

Fargo, North Dakota, 58103, United States

RECRUITING

Optima Research - Boardman- Site Number : 8400039

Boardman, Ohio, 44512, United States

RECRUITING

Columbia Dermatology & Aesthetics- Site Number : 8400047

Columbia, South Carolina, 29212, United States

RECRUITING

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

North Charleston, South Carolina, 29420, United States

RECRUITING

Complete Dermatology - Sugar Land- Site Number : 8400046

Sugar Land, Texas, 77479, United States

RECRUITING

Investigational Site Number : 0320004

Rosario, Santa Fe Province, 2000, Argentina

COMPLETED

Investigational Site Number : 0320008

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Investigational Site Number : 0320005

Buenos Aires, 1012, Argentina

RECRUITING

Investigational Site Number : 0320001

Buenos Aires, 1023, Argentina

COMPLETED

Investigational Site Number : 0320006

Buenos Aires, 1055, Argentina

RECRUITING

Investigational Site Number : 0320007

Buenos Aires, 1061, Argentina

RECRUITING

Investigational Site Number : 0320002

Buenos Aires, 1121, Argentina

RECRUITING

Investigational Site Number : 0320003

Buenos Aires, 1414, Argentina

RECRUITING

Investigational Site Number : 1240001

Calgary, Alberta, T2G 1B1, Canada

RECRUITING

Investigational Site Number : 1240008

Edmonton, Alberta, T6G 1C3, Canada

COMPLETED

Investigational Site Number : 1240002

London, Ontario, L6A 2C2, Canada

RECRUITING

Investigational Site Number : 1240003

Markham, Ontario, L3P 1X2, Canada

COMPLETED

Investigational Site Number : 1240006

Toronto, Ontario, M4C 1L1, Canada

RECRUITING

Investigational Site Number : 1240005

Montreal, Quebec, H4A 3T2, Canada

COMPLETED

Investigational Site Number : 1240004

Verdun, Quebec, H4G 2L8, Canada

RECRUITING

Investigational Site Number : 1560003

Beijing, 100191, China

RECRUITING

Investigational Site Number : 1560004

Chengdu, 610041, China

RECRUITING

Investigational Site Number : 1560009

Chongqing, 400016, China

RECRUITING

Investigational Site Number : 1560006

Guangzhou, 510018, China

RECRUITING

Investigational Site Number : 1560005

Guangzhou, 510080, China

RECRUITING

Investigational Site Number : 1560002

Hangzhou, 310006, China

RECRUITING

Investigational Site Number : 1560001

Shanghai, 200040, China

RECRUITING

Investigational Site Number : 1560011

Suzhou, 215006, China

RECRUITING

Investigational Site Number : 1560008

Wuhan, 430022, China

RECRUITING

Investigational Site Number : 2500001

Brest, 29200, France

RECRUITING

Investigational Site Number : 2500003

Nice, 06202, France

RECRUITING

Investigational Site Number : 2760005

Bad Bentheim, 48455, Germany

RECRUITING

Investigational Site Number : 2760002

Berlin, 12203, Germany

RECRUITING

Investigational Site Number : 2760004

Frankfurt, 60590, Germany

RECRUITING

Investigational Site Number : 2760003

Mainz, 55131, Germany

RECRUITING

Investigational Site Number : 2760001

Münster, 48149, Germany

RECRUITING

Investigational Site Number : 3480001

Budapest, 1036, Hungary

RECRUITING

Investigational Site Number : 3480009

Budapest, 1066, Hungary

RECRUITING

Investigational Site Number : 3480005

Debrecen, 4031, Hungary

RECRUITING

Investigational Site Number : 3480003

Szeged, 6720, Hungary

RECRUITING

Investigational Site Number : 3480011

Székesfehérvár, 8000, Hungary

RECRUITING

Investigational Site Number : 3480002

Zalaegerszeg, 8900, Hungary

RECRUITING

Azienda Ospedaliero-Universitaria di Ferrara-Site Number : 3800007

Cona, Ferrara, 44124, Italy

RECRUITING

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

Florence, Firenze, 50125, Italy

RECRUITING

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

Milan, Milano, 20122, Italy

RECRUITING

Investigational Site Number : 3800002

Rozzano, Milano, 20089, Italy

RECRUITING

Investigational Site Number : 3800006

Naples, Napoli, 80131, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001

Rome, Roma, 00168, Italy

RECRUITING

Azienda Ospedaliero Universitaria delle Marche-Site Number : 3800004

Ancona, 60126, Italy

RECRUITING

Investigational Site Number : 3920007

Urayasu, Chiba, 279-0011, Japan

RECRUITING

Investigational Site Number : 3920003

Obihiro, Hokkaido, 080-0013, Japan

RECRUITING

Investigational Site Number : 3920006

Sapporo, Hokkaido, 060-0063, Japan

RECRUITING

Investigational Site Number : 3920004

Habikino, Osaka, 583-8588, Japan

RECRUITING

Investigational Site Number : 3920002

Sakai, Osaka, 593-8324, Japan

RECRUITING

Investigational Site Number : 3920005

Izumo, Shimane, 693-8501, Japan

RECRUITING

Investigational Site Number : 3920001

Tachikawa, Tokyo, 190-0023, Japan

RECRUITING

Investigational Site Number : 6160001

Krakow, Lesser Poland Voivodeship, 30-033, Poland

RECRUITING

Investigational Site Number : 6160007

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

RECRUITING

Investigational Site Number : 6160003

Wroclaw, Lower Silesian Voivodeship, 51-318, Poland

ACTIVE NOT RECRUITING

Investigational Site Number : 6160003

Wroclaw, Lower Silesian Voivodeship, 51-503, Poland

RECRUITING

Investigational Site Number : 6160008

Warsaw, Masovian Voivodeship, 01-142, Poland

RECRUITING

Investigational Site Number : 6160005

Warsaw, Masovian Voivodeship, 02-172, Poland

RECRUITING

Investigational Site Number : 4100003

Busan, Busan, 49241, South Korea

COMPLETED

Investigational Site Number : 4100004

Ansan-si, Gyeonggi-do, 15355, South Korea

COMPLETED

Investigational Site Number : 4100005

Seoul, Seoul-teukbyeolsi, 03080, South Korea

COMPLETED

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 03722, South Korea

COMPLETED

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi, 05030, South Korea

RECRUITING

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 07441, South Korea

COMPLETED

Investigational Site Number : 4100007

Seoul, Seoul-teukbyeolsi, 07804, South Korea

RECRUITING

Investigational Site Number : 7240003

Barcelona, Barcelona [Barcelona], 08003, Spain

RECRUITING

Investigational Site Number : 7240006

Barcelona, Catalunya [Cataluña], 08041, Spain

RECRUITING

Investigational Site Number : 7240001

Pontevedra, Pontevedra [Pontevedra], 36002, Spain

RECRUITING

Investigational Site Number : 7240005

Alicante, 03010, Spain

RECRUITING

Investigational Site Number : 7240004

Córdoba, 14004, Spain

RECRUITING

Investigational Site Number : 1580003

Kaohsiung City, 833, Taiwan

RECRUITING

Investigational Site Number : 1580004

New Taipei City, 235, Taiwan

RECRUITING

Investigational Site Number : 1580001

Taipei, 100, Taiwan

RECRUITING

Investigational Site Number : 1580002

Taoyuan, 333, Taiwan

RECRUITING

Related Links

• EFC16973 Chronic Pruritus of Unknown Origin Website
• EFC16973 Plain Language Results Summary

MeSH Terms

Conditions

Pruritus

Interventions

dupilumab; fexofenadine

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Trial Transparency email recommended (Toll free number for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 2, 2022
• Study Start: February 15, 2022
• Primary Completion (Estimated): June 2, 2027
• Study Completion (Estimated): August 25, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (7); FR (2); HU (6); IT (7); CA (7); JP (7); ES (5); TW (4); CN (9); PL (6); AR (8); DE (5); US (18)