Treatment of chronic itching with dupilumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of dupilumab, administered subcutaneously, in adults suffering from chronic pruritus of unknown origin (CPUO). Participants aged 18 to 90 years with severe itching will be randomized to receive either dupilumab or a placebo for a treatment period of 12 to 24 weeks, following a screening and run-in phase. The study includes two parallel treatment arms, allowing for adaptive design based on initial results. After the treatment phase, participants will be monitored for an additional 12 weeks to assess long-term effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Modena Allergy + Asthma- Site Number : 8400038
  La Jolla, California, United States Recruiting
• FoxHall Dermatology- Site Number : 8400042
  Washington D.C., District of Columbia, United States Recruiting
• Palm Harbor Dermatology- Site Number : 8400024
  Belleair, Florida, United States Recruiting
• University of Miami Hospital- Site Number : 8400011
  Miami, Florida, United States Recruiting
• Skin Care Physicians of Georgia - Macon- Site Number : 8400030
  Macon, Georgia, United States Recruiting
• Aeroallergy Research Laboratory- Site Number : 8400036
  Savannah, Georgia, United States Recruiting

+44 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free number for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.