Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Prurigo Nodularis (PN)
In brief
Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)
Key facts
- Study ID
- NCT07236099
- Run by
- Beijing InnoCare Pharma Tech Co., Ltd.
- People needed
- 135
- Starts
- 2025-11-27
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Cahaba Dermatology and Skin Health Center — Birmingham, Alabama, United States (enrolling)
- Medical Dermatology Specialists — Phoenix, Arizona, United States (enrolling)
- Driven Research, LLC — Coral Gables, Florida, United States (enrolling)
- Cordova Research Institute — Sweetwater, Florida, United States (enrolling)
- Dawes Fretzin Clinical Research Group LLC — Indianapolis, Indiana, United States (enrolling)
- The Derm Institute of West Michigan — Caledonia, Michigan, United States (enrolling)
- Revival Research Institute, LLC — Troy, Michigan, United States (enrolling)
- Minnesota Clinical Study Center — New Brighton, Minnesota, United States (enrolling)
- Skin Specialists, PC — Omaha, Nebraska, United States (enrolling)
- Apex Clinical Research Center — Mayfield Heights, Ohio, United States (enrolling)
- The Second Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (enrolling)
- Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (enrolling)
- Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China (enrolling)
- The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
- Jingzhou Central Hospital — Jingzhou, Hubei, China (enrolling)
- Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
- The first hospital of Jilin University — Changchun, Jilin, China (enrolling)
- Shenyang Seventh People's Hospital — Shenyang, Liaoning, China (enrolling)
- Shandong Provincial Dermatology Hospital — Jinan, Shandong, China (enrolling)
- Chengdu Second People's Hospital — Chengdu, Sichuan, China (enrolling)
- Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (enrolling)
- Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital — Tianjin, Tianjin Municipality, China (enrolling)
- Affiliated Hangzhou First People's Hospital,School of Medicine ,Westlake University — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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