ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis

InnoCare Pharma

Status and phase: Enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: ICP-332 Tablets; Drug: ICP-332 Placebo Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06775860

ICP-CL-00604

Details and patient eligibility

About

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

Enrollment: 552 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

552 participants in 2 patient groups, including a placebo group

ICP-332

Experimental group

Treatment:

Drug: ICP-332 Tablets

Placebo

Placebo Comparator group

Treatment:

Drug: ICP-332 Placebo Tablets