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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT05263206

Registry updated: 2026-10-15
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Description

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.

Interventions

  • Dupilumab (Drug)
    Injection solution subcutaneous
  • Placebo (Drug)
    Injection solution SC
  • Fexofenadine (loratadine if not available) (Drug)
    Tablet or capsule Oral

Eligibility criteria

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.

Conditions

Pruritus

Locations

  • 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
  • Treasure Valley Medical Research- Site Number : 8400049 — Boise, Idaho, 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 Research- Site Number : 8400032 — North Charleston, South Carolina, United States
  • Complete Dermatology - 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 : 2500004 — Reims, 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 : 3480010 — Gyula, 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 : 3920009 — Matsudo, Chiba, Japan
  • Investigational Site Number : 3920007 — Urayasu, Chiba, Japan
  • Investigational Site Number : 3920006 — Sapporo, Hokkaido, Japan
  • Investigational Site Number : 3920008 — Yokohama, Kanagawa, 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 : 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 — Seoul, Seoul-teukbyeolsi, South Korea
  • Investigational Site Number : 4100002 — Seoul, Seoul-teukbyeolsi, South Korea
  • Investigational Site Number : 4100006 — Seoul, Seoul-teukbyeolsi, South Korea
  • Investigational Site Number : 4100001 — Seoul, Seoul-teukbyeolsi, South Korea
  • Investigational Site Number : 4100007 — Seoul, Seoul-teukbyeolsi, South Korea
  • Investigational Site Number : 7240003 — Barcelona, Catalunya [Cataluña], Spain
  • Investigational Site Number : 7240006 — Barcelona, Catalunya [Cataluña], Spain
  • Investigational Site Number : 7240001 — Pontevedra, Pontevedra [Pontevedra], Spain
  • Investigational Site Number : 7240005 — Alicante, Spain
  • Investigational Site Number : 7240004 — Córdoba, Spain
  • Investigational Site Number : 1580003 — Kaohsiung City, Taiwan
  • Investigational Site Number : 1580004 — New Taipei City, Taiwan
  • Investigational Site Number : 1580001 — Taipei, Taiwan
  • Investigational Site Number : 1580002 — Taoyuan City, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record