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

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: Prurigo Nodularis (PN)
• Intervention / Treatment: Drug: ICP-322; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alexia Lu; Phone Number: +86-010-66609745; Email: CO_HGRAC@innocarepharma.com

Study Locations

• China
  • Anhui
    • Wuhu, Anhui, China, 241000
      • Recruiting
      • The Second Affiliated Hospital of Wannan Medical College
      • 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
• United States
  • Ohio
    • Mayfield Heights, Ohio, United States, 44124
      • Recruiting
      • Apex Clinical Research Center
      • Contact: Jorge A Garcia-Zuazaga

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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)	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	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)	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)	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]		Baseline through week 40
Maximum concentration (Cmax)	Maximum concentration (Cmax) of ICP-322	Baseline through week 40
Area Under Concentration Versus Time Curve (AUC)	Area Under Concentration Versus Time Curve (AUC) of ICP-322	Baseline through week 40

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

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): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 8, 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