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ICP-332 in Subjects With Mode...

ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis

Last Updated: 2025-09-08

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

PHASE3

Total Enrollment

552 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-14

Study Completion Date

2026-12-25

Brief Summary

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A randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of oral ICP-332 in subjects with moderate to severe atopic dermatitis

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Detailed Description

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Conditions

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Atopic Dermatitis

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

Group Type EXPERIMENTAL

ICP-332 Tablets

Intervention Type DRUG

ICP-332 will be administered as tablet

Placebo

Group Type PLACEBO_COMPARATOR

ICP-332 Placebo Tablets

Intervention Type DRUG

ICP-332 Placebo will be administered as tablet

Interventions

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ICP-332 Tablets

ICP-332 will be administered as tablet

Intervention Type DRUG

ICP-332 Placebo Tablets

ICP-332 Placebo will be administered as tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects between 18 and 75 years of age.
2. Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year
3. Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.
4. Subjects must meet the following criteria for disease activity:

* Eczema Area and Severity Index (EASI) score ≥ 16 ;
* (Body Surface Area )BSA affected by AD ≥ 10% ;
* (validated Investigator's Global Assessment-AD)vIGA-AD score ≥3 ;
* Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
5. Women of childbearing potential (WOCBP) and Men must agree

5\. Women of childbearing potential (WOCBP) and Men must agree to contraception. 6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

1. Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.
2. Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
3. Pregnant or breastfeeding females.
4. History of any clinically major diseases, with the exception of atopic dermatitis.
5. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING