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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-27

Study Completion Date

2027-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Prurigo Nodularis (PN)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ICP-332 80mg

Group Type EXPERIMENTAL

ICP-322

Intervention Type DRUG

ICP-322 Tablets

ICP-332 120mg

Group Type EXPERIMENTAL

ICP-322

Intervention Type DRUG

ICP-322 Tablets

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

ICP-332 Placebo Tablets

Interventions

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ICP-322

ICP-322 Tablets

Intervention Type DRUG

Placebo

ICP-332 Placebo Tablets

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No