Recruiting
Phase 3

Dupilumab

Sponsor:

Sanofi

Code:

NCT05263206

Conditions

Pruritus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dupilumab

Placebo

Fexofenadine (loratadine if not available)

Study Details

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- 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

Study ID

NCT05263206

Start date

Feb 15, 2022

Status verified date

Jul, 2026

Completion date

Aug 25, 2027

Anticipated

Primary completion date

Jun 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

284 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Dupilumab

Injection solution subcutaneous

Placebo

Injection solution SC

Fexofenadine (loratadine if not available)

Tablet or capsule Oral

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 ]
  • Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12 [ Time Frame: Baseline to Week 12 ]

Central Contacts and Locations

Central contacts

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

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

Locations

Modena Allergy + Asthma- Site Number : 8400038

Recruiting

La Jolla, California, United States, 92037

FoxHall Dermatology- Site Number : 8400042

Recruiting

Washington D.C., District of Columbia, United States, 20016

Palm Harbor Dermatology- Site Number : 8400024

Recruiting

Belleair, Florida, United States, 32756

University of Miami Hospital- Site Number : 8400011

Recruiting

Miami, Florida, United States, 33136

Skin Care Physicians of Georgia - Macon- Site Number : 8400030

Recruiting

Macon, Georgia, United States, 31217

Aeroallergy Research Laboratory- Site Number : 8400036

Recruiting

Savannah, Georgia, United States, 31406

Dawes Fretzin Clinical Research- Site Number : 8400007

Recruiting

Indianapolis, Indiana, United States, 46256

Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031

Recruiting

Louisville, Kentucky, United States, 40241

Tulane University School of Medicine- Site Number : 8400045

Recruiting

New Orleans, Louisiana, United States, 70112

Johns Hopkins Hospital- Site Number : 8400020

Recruiting

Baltimore, Maryland, United States, 21287

The Asthma and Allergy Center- Site Number : 8400014

Recruiting

Bellevue, Nebraska, United States, 68123

Mount Sinai - Union Square- Site Number : 8400034

Recruiting

New York, New York, United States, 10003

AXIS Clinicals - Fargo- Site Number : 8400037

Recruiting

Fargo, North Dakota, United States, 58103

Optima Research - Boardman- Site Number : 8400039

Recruiting

Boardman, Ohio, United States, 44512

Columbia Dermatology & Aesthetics- Site Number : 8400047

Recruiting

Columbia, South Carolina, United States, 29212

National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400032

Recruiting

North Charleston, South Carolina, United States, 29420

Complete Dermatology - Sugar Land- Site Number : 8400046

Recruiting

Sugar Land, Texas, United States, 77479

Investigational Site Number : 1240001

Recruiting

Calgary, Alberta, Canada, T2G 1B1

Investigational Site Number : 1240002

Recruiting

London, Ontario, Canada, L6A 2C2

Investigational Site Number : 1240006

Recruiting

Toronto, Ontario, Canada, M4C 1L1

Investigational Site Number : 1240004

Recruiting

Verdun, Quebec, Canada, H4G 2L8

More Information

Sponsor

Sanofi

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi on 2026-07-06.