ICP-332 in Subjects with Moderate to Severe Atopic Dermatitis

Phase 3

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: ICP-332 Tablets; Drug: ICP-332 Placebo Tablets

• Registration Number: NCT06775860
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-14
• Study First Submitted: 2024-12-25
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-11-25
• Study Completion: 2026-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 552

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

6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICP-332	ICP-332 Tablets	-
Placebo	ICP-332 Placebo Tablets	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline	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	16 weeks

Trial Locations

Locations (70)

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

The Second Affiliated Hospital of Wannan Medical College; 🇨🇳 Wuhu, Anhui, China

Capital Medical University Affiliated Beijing Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Capital Medical University Affiliated Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Chongqing Traditional Chinese Medicine Hospital; 🇨🇳 Chongqing, Chongqing, China

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