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

Beijing InnoCare Pharma Tech Co., Ltd.62 sites in 1 country552 target enrollmentNovember 14, 2024

InterventionsICP-332 Tablets ICP-332 Placebo Tablets

DrugsICP-332 Tablets ICP-332 Placebo Tablets

Overview

Phase: Phase 3
Intervention: ICP-332 Tablets
Conditions: Not specified
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment: 552
Locations: 62
Primary Endpoint: Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 14, 2024

End Date

December 25, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects between 18 and 75 years of age.
•Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year
•Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.
•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 ≥
•Women of childbearing potential (WOCBP) and Men must agree
•5\. Women of childbearing potential (WOCBP) and Men must agree to contraception.

Exclusion Criteria

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

Arms & Interventions

ICP-332

Intervention: ICP-332 Tablets

Placebo

Intervention: ICP-332 Placebo Tablets

Outcomes

Primary Outcomes

Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline

Time Frame: 16 weeks

Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from Baseline

Time Frame: 16 weeks