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

September 10, 2026 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Wuhu, Anhui, China, 241000
        • Recruiting
        • The Second Affiliated Hospital of Wannan Medical University
        • Contact:
          • Ruzhi Zhang
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Jianzhong Zhang
        • Contact:
          • Cheng Zhou
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Tao Cai
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
          • Niu Xiang
    • Guangdong
      • Guangzhou, Guangdong, China, 510091
        • Recruiting
        • Dermatology Hospital of Southern Medical University
        • Contact:
          • Xiaohua Wang
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
          • Guoqiang Zhang
    • Hubei
      • Jingzhou, Hubei, China, 434020
        • Recruiting
        • Jingzhou Central Hospital
        • Contact:
          • Yi Sun
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
          • Juan Su
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Shanshan Li
    • Liaoning
      • Shenyang, Liaoning, China, 110003
        • Recruiting
        • Shenyang Seventh People's Hospital
        • Contact:
          • Zhen Wang
    • Shandong
      • Jinan, Shandong, China, 250022
        • Recruiting
        • Shandong Provincial Dermatology Hospital
        • Contact:
          • Furen Zhang
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Lixia Zhang
      • Chengdu, Sichuan, China, 610021
        • Recruiting
        • Chengdu second people's hospital
        • Contact:
          • Yanyan Feng
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300131
        • Recruiting
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
        • Contact:
          • Litao Zhang
        • Contact:
          • Yan Xu
    • Zhejiang
      • Hangzhou, Zhejiang, China, 250022
        • Recruiting
        • Affiliated Hangzhou First People's Hospital,School of Medicine ,Westlake University
        • Contact:
          • Liming Wu
  • France
      • Brest, France, 29690
        • Recruiting
        • Chu de Brest - Hopital Morvan
        • Contact:
          • Laurent Misery
  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • Uni Berlin Chartie Derma
        • Contact:
          • Martin Metz
      • Darmstadt, Germany, 64283
        • Recruiting
        • Rosenpark Research
        • Contact:
          • Oliver Weirich
      • Leipzig, Germany, 04103
        • Recruiting
        • Uni Leipzig Derma
        • Contact:
          • Jan-Christoph Simon
      • Mainz, Germany, 55128
        • Recruiting
        • Dermatologischen Gemeinschaftspraxis Dres. Quist
        • Contact:
          • Seven Quist
  • Poland
      • Bialystok, Poland, 15-375
        • Recruiting
        • Specderm Poznanska
        • Contact:
          • Maria Poznanska
      • Gdansk, Poland, 80-280
        • Recruiting
        • AKK MEDlCAL Spółka z ograniczoną Odpowiedzialnością, Centrum Medyczne Tu się Leczy
        • Contact:
          • lzABELA KARAMoN
      • Kielce, Poland, 25-553
        • Recruiting
        • Zdybski Ned SP.Z.O.O
        • Contact:
          • Jacek Zdybski
      • Lodz, Poland, 91-495
        • Recruiting
        • Amicare Centrum Medyczne
        • Contact:
          • Aleksandra Bala-Wojsznis
      • Malbork, Poland, 82-200
        • Recruiting
        • Centrum Badawcze Panaceum
        • Contact:
          • Anna Sobiezek-Kundro
      • Nowa Sól, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia
        • Contact:
          • Anna Kacalak-Rzepka
      • Poznan, Poland, 60-324
        • Recruiting
        • Twoja Przychodnia Centrum Medyczne
        • Contact:
          • Leszek Bartoszak
      • Rzeszów, Poland, 35-055
        • Recruiting
        • Uniwersytecki Szpital Kliniczny
        • Contact:
          • Adam Reich
      • Warsaw, Poland, 25-553
        • Recruiting
        • Klinika Ambroziak Dermatologia
        • Contact:
          • Monika Kalowska
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Recruiting
        • Cahaba Dermatology and Skin Health Center
        • Contact:
          • Vlada Groysman
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Medical Dermatology Specialists
        • Contact:
          • Lindsay Ackerman
    • California
      • Fremont, California, United States, 94538
        • Recruiting
        • Center for Dermatology Clinical Research, Inc.
        • Contact:
          • Sunil S Dhawan
    • Florida
      • Miami, Florida, United States, 33126
        • Recruiting
        • Driven Research, LLC
        • Contact:
          • Javier Alonso-Llamazares
      • Sweetwater, Florida, United States, 33182
        • Recruiting
        • Cordova Research Institute
        • Contact:
          • Maria Cartaya
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Dawes Fretzin Clinical Research Group LLC
        • Contact:
          • Kenneth W. Dawes
    • Michigan
      • Auburn Hills, Michigan, United States, 48326
        • Recruiting
        • Oakland Hills Dermatology
        • Contact:
          • Christopher Buatti
      • Caledonia, Michigan, United States, 49316
        • Recruiting
        • The Derm Institute of West Michigan
        • Contact:
          • Kristi Hawley
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Revival Research Institute, LLC
        • Contact:
          • Ali Moiin
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Recruiting
        • Minnesota Clinical Study Center
        • Contact:
          • Steven Kempers
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Skin Specialists, PC
        • Contact:
          • Joel Schlessinger
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • StracSkin, PLLC
        • Contact:
          • Abel Jarell
    • Ohio
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Apex Clinical Research Center
        • Contact:
          • Jorge A Garcia-Zuazaga
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Recruiting
        • International Clinical Research - Tennessee LLC
        • Contact:
          • Christina Feser

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
ICP-332 Placebo Tablets
Experimental: ICP-332 80mg
Drug: ICP-322
ICP-322 Tablets
Experimental: ICP-332 120mg
Drug: ICP-322
ICP-322 Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak pruritus-numeric rate scale (PP NRS)
Time Frame: 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'.
Baseline to week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in PP NRS score
Time Frame: Baseline through week 40
Proportion of participants achieving ≥ 4-point improvement in PP NRS score (PP NRS ≥ 4) over time
Baseline through week 40
Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1)
Time Frame: Baseline through week 40
Proportion of participants achieving Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) over time
Baseline through week 40
Dermatology Life Quality Index (DLQI)
Time Frame: Baseline through week 40
Change from baseline in Dermatology Life Quality Index (DLQI) score over time. The DLQI comprises 10 items assessing the impact of skin disease on patients' health-related quality of life (HRQoL) over the previous week. Overall scoring ranges from 0 to 30, with a high score indicative of a poor HRQoL
Baseline through week 40
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Baseline through week 40
Baseline through week 40
Maximum concentration (Cmax)
Time Frame: Baseline through week 40
Maximum concentration (Cmax) of ICP-322
Baseline through week 40
Area Under Concentration Versus Time Curve (AUC)
Time Frame: Baseline through week 40
Area Under Concentration Versus Time Curve (AUC) of ICP-322
Baseline through week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

October 27, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ICP-CL-00609

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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