Status:
RECRUITING
Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)
Lead Sponsor:
Sanofi
Conditions:
Pruritus
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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-...
Detailed Description
Study duration per participant will be up to 44 weeks for both Study A and Study B.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 25 2027
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT05263206
Start Date
February 15 2022
End Date
August 25 2027
Last Update
December 17 2025
Active Locations (85)
Enter a location and click search to find clinical trials sorted by distance.
1
Kern Allergy and Medical Research- Site Number : 8400016
Bakersfield, California, United States, 93301
2
Modena Allergy + Asthma- Site Number : 8400038
La Jolla, California, United States, 92037
3
FoxHall Dermatology- Site Number : 8400042
Washington D.C., District of Columbia, United States, 20016
4
Palm Harbor Dermatology- Site Number : 8400024
Belleair, Florida, United States, 32756