RecruitingPhase 2NCT07236099
Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment
135 participants
Start Date
Nov 27, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria8
- Voluntarily sign informed consent forms before any investigational procedure(s) are performed.
- Male or female aged between 18 and 75 years at the time of signing the informed consent.
- Clinical diagnosis of PN by a dermatologist for at least 3 months before the Screening visit.
- 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.
- PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits.
- IGA-CPG-S score ≥ 3 at both the screening and the baseline (Day 1) visits.
- 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 Criteria2
- 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 .
- 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.
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Interventions
DRUGICP-322
ICP-322 Tablets
DRUGPlacebo
ICP-332 Placebo Tablets
Locations(34)
View Full Details on ClinicalTrials.gov
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NCT07236099