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

Conditions

• Pruritus

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Feb 15, 2022

Status verified

Jun 2026

Primary completion

Jun 2, 2027

Completion

Aug 25, 2027

Study Design

Enrollment

284 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) on top of non-sedative antihistamine and moisturizer
• Placebo Comparator: Placebo
  Loading dose administered SC, followed by SC Q2W on top of non-sedative antihistamine and moisturizer

Primary Outcome Measure

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 [ Time Frame: Baseline to Week 24 ]

Central Contacts

• Trial Transparency email recommended (Toll free number for US & Canada)
  800-633-1610
  [email protected]

Locations (18)

Find similar trials in Bakersfield, CA

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