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Recruiting Phase 2

Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis

NCT07236099 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2025-11-27
Last updated
2026-09-14

Condition(s) studied

Prurigo Nodularis (PN)

Investigational drug(s) / intervention(s)

ICP-322Placebo

ICP-322: ICP-322 Tablets

Placebo: ICP-332 Placebo Tablets

Study summary

Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Peak pruritus-numeric rate scale (PP NRS) — Baseline to week 16
    Percent change from baseline of weekly average in Peak pruritus-numeric rate scale (PP NRS) at Week 16. Participants will be asked to rate their itch at the worst moment during the previous 24 hours. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.

Trial sites (43)

FacilityCityRegionStatus
Cahaba Dermatology and Skin Health Center Birmingham Alabama Recruiting
Medical Dermatology Specialists Phoenix Arizona Recruiting
Center for Dermatology Clinical Research, Inc. Fremont California Recruiting
Driven Research, LLC Miami Florida Recruiting
Cordova Research Institute Sweetwater Florida Recruiting
Dawes Fretzin Clinical Research Group LLC Indianapolis Indiana Recruiting
Oakland Hills Dermatology Auburn Hills Michigan Recruiting
The Derm Institute of West Michigan Caledonia Michigan Recruiting
Revival Research Institute, LLC Troy Michigan Recruiting
Minnesota Clinical Study Center New Brighton Minnesota Recruiting
Skin Specialists, PC Omaha Nebraska Recruiting
StracSkin, PLLC Portsmouth New Hampshire Recruiting
Apex Clinical Research Center Mayfield Heights Ohio Recruiting
International Clinical Research - Tennessee LLC Murfreesboro Tennessee Recruiting
The Second Affiliated Hospital of Wannan Medical University Wuhu Anhui Recruiting
Peking University People's Hospital Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian Recruiting
Dermatology Hospital of Southern Medical University Guangzhou Guangdong Recruiting
The First Hospital of Hebei Medical University Shijiazhuang Hebei Recruiting
Jingzhou Central Hospital Jingzhou Hubei Recruiting
Xiangya Hospital of Central South University Changsha Hunan Recruiting
The first hospital of Jilin University Changchun Jilin Recruiting
Shenyang Seventh People's Hospital Shenyang Liaoning Recruiting
Shandong Provincial Dermatology Hospital Jinan Shandong Recruiting
Chengdu Second People's Hospital Chengdu Sichuan Recruiting
Sichuan Provincial People's Hospital Chengdu Sichuan Recruiting
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital Tianjin Tianjin Municipality Recruiting
Affiliated Hangzhou First People's Hospital,School of Medicine ,Westlake University Hangzhou Zhejiang Recruiting
Chu de Brest - Hopital Morvan Brest France Recruiting
Uni Berlin Chartie Derma Berlin Germany Recruiting
Rosenpark Research Darmstadt Germany Recruiting
Uni Leipzig Derma Leipzig Germany Recruiting
Dermatologischen Gemeinschaftspraxis Dres. Quist Mainz Germany Recruiting
Specderm Poznanska Bialystok Poland Recruiting
AKK MEDlCAL Spółka z ograniczoną Odpowiedzialnością, Centrum Medyczne Tu się Leczy Gdansk Poland Recruiting
Zdybski Ned SP.Z.O.O Kielce Poland Recruiting
Amicare Centrum Medyczne Lodz Poland Recruiting
Centrum Badawcze Panaceum Malbork Poland Recruiting
Twoja Przychodnia Nowa Sól Poland Recruiting

+ 3 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07236099 on ClinicalTrials.gov ↗ ← All trials in the USA