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NCT07236099PHASE2Recruiting

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

Beijing InnoCare Pharma Tech Co., Ltd.

Start Date

11/27/2025

Completion Date

10/1/2027

Summary

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

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

ICP-322

DRUG

Placebo

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Conditions

Prurigo Nodularis (PN)

Locations

Cahaba Dermatology and Skin Health Center

Birmingham, Alabama 35244

United States

Medical Dermatology Specialists

Phoenix, Arizona 85006

United States

Driven Research, LLC

Coral Gables, Florida 33134

United States

Cordova Research Institute

Sweetwater, Florida 33182

United States

Dawes Fretzin Clinical Research Group LLC

Indianapolis, Indiana 46250

United States

The Derm Institute of West Michigan

Caledonia, Michigan 49316

United States

Revival Research Institute, LLC

Troy, Michigan 48084

United States

Minnesota Clinical Study Center

New Brighton, Minnesota 55112

United States

Skin Specialists, PC

Omaha, Nebraska 68144

United States

Apex Clinical Research Center

Mayfield Heights, Ohio 44124

United States

The Second Affiliated Hospital of Wannan Medical College

Wuhu, Anhui 241000

China

Peking University People's Hospital

Beijing, Beijing Municipality 100044

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality 400016

China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian 350005

China

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong 510091

China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei 050000

China

Jingzhou Central Hospital

Jingzhou, Hubei 434020

China

Xiangya Hospital of Central South University

Changsha, Hunan 410008

China

The first hospital of Jilin University

Changchun, Jilin 130021

China

Shenyang Seventh People's Hospital

Shenyang, Liaoning 110003

China

Shandong Provincial Dermatology Hospital

Jinan, Shandong 250022

China

Chengdu Second People's Hospital

Chengdu, Sichuan 610021

China

Sichuan Provincial People's Hospital

Chengdu, Sichuan 610072

China

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, Tianjin Municipality 300131

China

Affiliated Hangzhou First People's Hospital,School of Medicine ,Westlake University

Hangzhou, Zhejiang 250022

China

Uni Berlin Chartie Derma

Berlin, 12203

Germany

Rosenpark Research

Darmstadt, 64283

Germany

Uni Leipzig Derma

Leipzig, 04103

Germany

Dermatologischen Gemeinschaftspraxis Dres. Quist

Mainz, 55128

Germany

AKK MEDlCAL Spółka z ograniczoną Odpowiedzialnością, Centrum Medyczne Tu się Leczy

Gdansk, 80-280

Poland

Amicare Centrum Medyczne

Lodz, 91-495

Poland

Centrum Badawcze Panaceum

Malbork, 82-200

Poland

Twoja Przychodnia

Nowa Sól, 67-100

Poland

Twoja Przychodnia Centrum Medyczne

Poznan, 60-324

Poland