RecruitingPhase 3

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

United States284 participantsStarted 2022-02-15

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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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 a…

What they're measuring

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

Timeframe: 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

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT05263206

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-02

Contact for this trial

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

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

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