Recruiting
Phase 2

ICP-332

Sponsor:

Beijing InnoCare Pharma Tech Co., Ltd.

Code:

NCT07236099

Conditions

Prurigo Nodularis (PN)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ICP-322

Placebo

Study Details

Brief summary:

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

Conditions

Prurigo Nodularis (PN)

Study ID

NCT07236099

Start date

Nov 27, 2025

Status verified date

Dec, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

135 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ICP-332 80mg

experimental: ICP-332 120mg

placebo comparator: Placebo

Interventions

ICP-322

ICP-322 Tablets

Placebo

ICP-332 Placebo Tablets

Primary outcome measure

  • Peak pruritus-numeric rate scale (PP NRS) [ Time Frame: Baseline to week 16 ]

Central Contacts and Locations

Locations

Cahaba Dermatology and Skin Health Center

Recruiting

Birmingham, Alabama, United States, 35244

Medical Dermatology Specialists

Recruiting

Phoenix, Arizona, United States, 85006

Driven Research, LLC

Recruiting

Coral Gables, Florida, United States, 33134

Cordova Research Institute

Recruiting

Sweetwater, Florida, United States, 33182

Dawes Fretzin Clinical Research Group LLC

Recruiting

Indianapolis, Indiana, United States, 46250

The Derm Institute of West Michigan

Recruiting

Caledonia, Michigan, United States, 49316

Revival Research Institute, LLC

Recruiting

Troy, Michigan, United States, 48084

Minnesota Clinical Study Center

Recruiting

New Brighton, Minnesota, United States, 55112

Skin Specialists, PC

Recruiting

Omaha, Nebraska, United States, 68144

Apex Clinical Research Center

Recruiting

Mayfield Heights, Ohio, United States, 44124

More Information

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Last update posted

Jul 23, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Beijing InnoCare Pharma Tech Co., Ltd. on 2026-07-23.