RECRUITING

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

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.

Conditions

Pruritus
Talk to us

Related Conditions:

Pruritus

Study Overview

On this page

Study Details

Study overview

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.

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)

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

Condition
Pruritus
Intervention / Treatment

-

Contacts and Locations

Bakersfield

Kern Allergy and Medical Research- Site Number : 8400016, Bakersfield, California, United States, 93301

La Jolla

Modena Allergy + Asthma- Site Number : 8400038, La Jolla, California, United States, 92037

Washington

FoxHall Dermatology- Site Number : 8400042, Washington, District of Columbia, United States, 20016

Belleair

Palm Harbor Dermatology- Site Number : 8400024, Belleair, Florida, United States, 32756

Miami

University of Miami Hospital- Site Number : 8400011, Miami, Florida, United States, 33136

Macon

Skin Care Physicians of Georgia - Macon- Site Number : 8400030, Macon, Georgia, United States, 31217

Savannah

Aeroallergy Research Laboratory- Site Number : 8400036, Savannah, Georgia, United States, 31406

Indianapolis

Dawes Fretzin Clinical Research- Site Number : 8400007, Indianapolis, Indiana, United States, 46256

Louisville

Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031, Louisville, Kentucky, United States, 40241

Baltimore

Johns Hopkins Hospital- Site Number : 8400020, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Study Record Dates

2027-08-25