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
1 other identifier
interventional
135
2 countries
16
Brief Summary
Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2025
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2025
CompletedFirst Posted
Study publicly available on registry
November 19, 2025
CompletedStudy Start
First participant enrolled
November 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
April 9, 2026
December 1, 2025
1.3 years
October 27, 2025
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Improvement in PP NRS score
Baseline through week 40
Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1)
Baseline through week 40
Dermatology Life Quality Index (DLQI)
Baseline through week 40
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Baseline through week 40
Maximum concentration (Cmax)
Baseline through week 40
- +1 more secondary outcomes
Study Arms (3)
ICP-332 80mg
EXPERIMENTALICP-332 120mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2025
First Posted
November 19, 2025
Study Start
November 27, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
April 9, 2026
Record last verified: 2025-12