ICP-332 for adults 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

This will test whether ICP-332 can reduce severe itching and the nodules in adults with prurigo nodularis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Locations: 16 sites (Mayfield Heights, Ohio and 15 other locations)
• Trial ID: NCT07236099 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with confirmed prurigo nodularis for ≥3 months, bilateral disease with ≥20 lesions, severe itch (PP NRS ≥7), and prior inadequate response to topical corticosteroids are the intended participants.

Not a fit: People with mild PN, fewer than 20 lesions, active moderate-to-severe atopic dermatitis, or those unable to attend the listed clinic locations are unlikely to receive benefit from this trial.

Why it matters

Potential benefit: If effective, ICP-332 could reduce severe itch and the number of nodules and improve quality of life for people with prurigo nodularis.

How similar studies have performed: Some targeted biologic therapies have shown benefit in prurigo nodularis, but ICP-332 appears to be a novel agent with limited published phase 2 data so far.

Eligibility criteria

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 this trial is running

Mayfield Heights, Ohio and 15 other locations

• Apex Clinical Research Center — Mayfield Heights, Ohio, United States (Recruiting)
• The Second Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Recruiting)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
• Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• Jingzhou Central Hospital — Jingzhou, Hubei, China (Recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• The first hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Shenyang Seventh People's Hospital — Shenyang, Liaoning, China (Recruiting)
• Shandong Provincial Dermatology Hospital — Jinan, Shandong, China (Recruiting)
• Chengdu Second People's Hospital — Chengdu, Sichuan, China (Recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
• Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Affiliated Hangzhou First People's Hospital,School of Medicine ,Westlake University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Alexia Lu

Conditions Prurigo Nodularis