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NCT Number: NCT06775860

ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ≥ 4.
  • Women of childbearing potential (WOCBP) and Men must agree
  • 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

  • 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.

Treatment and study plan

ICP-332 Tablets

Drug

ICP-332 will be administered as tablet

ICP-332 placebo Tablets

Drug

ICP-332 Placebo will be administered as tablet

Primary outcomes

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

    Time frame: 16 weeks

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Pengcheng Lei

CONTACT

[email protected]

+86 18501252185

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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