ICP-332 for adults with prurigo nodularis

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 Phase 2 interventional trial compares ICP-332 to placebo in adults with prurigo nodularis who have widespread bilateral lesions and severe itch. Eligible participants are 18–75 years old, have a clinical diagnosis of PN for at least three months, at least 20 pruriginous lesions with bilateral distribution, a PP NRS score ≥7, and an IGA-CPG-S score ≥3, and a history of inadequate response to medium-or-higher potency topical corticosteroids. Participants will be assigned to receive ICP-332 or placebo and followed for efficacy and safety outcomes, including changes in itch scores and lesion counts. Study sites include clinics in the United States (Ohio) and hospitals in Anhui and Beijing, China, with Beijing InnoCare Pharma Tech as the sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria :

1. Voluntarily sign informed consent forms before any investigational procedure(s) are performed.
2. Male or female aged between 18 and 75 years at the time of signing the informed consent.
3. Clinical diagnosis of PN by a dermatologist for at least 3 months before the Screening visit.
4. At least 20 pruriginous lesions on the entire body with a bilateral distribution (on both legs, and/or both arms and/or trunk) at both screening and the baseline (Day 1) visits.
5. PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits.
6. IGA-CPG-S score ≥ 3 at both the screening and the baseline (Day 1) visits.
7. History of inadequate response to topical corticosteroid of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).

Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

1. Patients with a documented AD severity moderate to severe presence of skin morbidities other than PN and mild AD that may interfere with the assessment of the study outcomes. PN secondary to medications .
2. Any uncontrolled or serious disease, or any medical, psychological, or surgical condition including relevant laboratory abnormalities at screening that may either interfere with the interpretation of the clinical trial results and/or, in the investigator's judgment, would adversely affect the patient's participation in the study. Active chronic or acute infection participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.

Where it's running

• Cahaba Dermatology and Skin Health Center
  Birmingham, Alabama, United States Recruiting
• Medical Dermatology Specialists
  Phoenix, Arizona, United States Recruiting
• Center for Dermatology Clinical Research, Inc.
  Fremont, California, United States Recruiting
• Driven Research, LLC
  Miami, Florida, United States Recruiting
• Cordova Research Institute
  Sweetwater, Florida, United States Recruiting
• Dawes Fretzin Clinical Research Group LLC
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Study coordinator: Alexia Lu
• Email: CO_HGRAC@innocarepharma.com
• Phone: +86-010-66609745

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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.