Clinical Trials in the USA / NCT07236099
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More Beijing InnoCare Pharma Tech Co., Ltd. trials in the USA
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