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Treatment of chronic itching with dupilumab

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)

PHASE3 · Sanofi · NCT05263206

This study is testing if a medication called dupilumab can help adults with severe chronic itching feel better.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment284 (estimated)
Ages18 Years to 90 Years
SexAll
SponsorSanofi (industry)
Drugs / interventionsdupilumab
Locations91 sites (Bakersfield, California and 90 other locations)
Trial IDNCT05263206 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with chronic pruritus of unknown origin affecting multiple body areas and a history of inadequate response to previous treatments.

Not a fit: Patients with chronic pruritus due to known dermatological, systemic, neuropathic, psychogenic causes, or drug-related origins may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate chronic itching for patients suffering from CPUO.

How similar studies have performed: Other studies have shown promising results with dupilumab for various allergic conditions, suggesting potential success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Bakersfield, California and 90 other locations

+41 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Pruritus

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.