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Evaluating ICP-332 for treating 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

PHASE3 · Beijing InnoCare Pharma Tech Co., Ltd. · NCT06775860

This study is testing a new oral medication called ICP-332 to see if it can help people with moderate to severe atopic dermatitis who haven't found relief from other treatments.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment552 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBeijing InnoCare Pharma Tech Co., Ltd. (industry)
Locations62 sites (Hefei, Anhui and 61 other locations)
Trial IDNCT06775860 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial is a randomized, double-blind, placebo-controlled study that aims to assess the efficacy and safety of oral ICP-332 in individuals suffering from moderate to severe atopic dermatitis. Participants will receive either the active medication or a placebo while their condition is monitored over the course of the trial. The study focuses on patients who have not adequately responded to topical treatments and have significant disease activity as measured by specific clinical scores.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a clinical diagnosis of chronic atopic dermatitis and significant disease activity.

Not a fit: Patients who have previously shown inadequate response to any JAK inhibitor for atopic dermatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new oral option for patients with moderate to severe atopic dermatitis who have not responded well to existing therapies.

How similar studies have performed: Other studies evaluating similar oral treatments for atopic dermatitis have shown promise, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Hefei, Anhui and 61 other locations

+12 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Atopic Dermatitis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.