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

Study on the Efficacy and Safety of Investigational Medication for Chronic Pruritus of Unknown Origin

Recruiting
18 years - 90 years
All
Phase 3
208 participants needed
5 Locations

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 may 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 during 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 (Study A) or 12 weeks (Study B) with either dupilumab or matching placebo in addition to their antihistamine and emollient regimen. The treatment period for both study A and B will be followed by a 12-week follow-up period.

Study Details

Study duration per participant will be up to 44 weeks (Study A) and 32 weeks (Study B).

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pruritus
  • Age: 18 years - 90 years
  • Gender: All

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.

Updated on 10 Feb 2025. Study ID: NCT05263206

This study investigates the effectiveness and safety of an investigational medication in treating adults with chronic pruritus of unknown origin (CPUO). Pruritus is a medical term for severe itching. The study includes two separate, similar investigations (Study A and Study B) involving adult participants aged 18 to 90 years. Participants will be randomly assigned to one of two study arms to receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.

Participants will undergo an initial screening period lasting up to 4 weeks, followed by a 4-week run-in period where they will use a non-sedative antihistamine and a moisturizer. Those who continue to experience severe itching will then be treated for either 24 weeks (Study A) or 12 weeks (Study B) with the investigational medication or placebo, alongside their existing antihistamine and moisturizer regimen. A follow-up period of 12 weeks will occur after the treatment phase.

  • Who can participate: Adults aged 18 to 90 who have had chronic pruritus for at least 6 months and have severe itch scores are eligible. Participants must have pruritus affecting at least two body areas and should have tried previous treatments without success.
  • Study details: Participants will be asked to take part in a screening and run-in period before receiving treatment. They will continue using a non-sedative antihistamine and moisturizer during the study. The investigational medication will be compared to a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.

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