NCT05263206

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study duration per participant will be up to 44 weeks for both Study A and Study B.

Conditions

• Pruritus

Interventions

Type	Name	Description
DRUG	Dupilumab	Injection solution subcutaneous
DRUG	Placebo	Injection solution SC
DRUG	Fexofenadine (loratadine if not available)	Tablet or capsule Oral

Timeline

• Start date: 2022-02-15
• Primary completion: 2027-06-02
• Completion: 2027-08-25
• First posted: 2022-03-02
• Last updated: 2026-04-09

Locations

91 sites across 13 countries: United States, Argentina, Canada, China, France, Germany, Hungary, Italy, Japan, Poland, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study