Evaluating ICP-332 for treating moderate to severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• The Second Affiliated Hospital of Wannan Medical College
  Wuhu, Anhui, China Recruiting
• Capital Medical University Affiliated Beijing Chaoyang Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Capital Medical University Affiliated Beijing Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pengcheng Lei
• Email: pengcheng.lei@innocarepharma.com
• Phone: +86 18501252185

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• ADBest TREAT Registry for adults with atopic dermatitis

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• Tilrekimig for moderate-to-severe eczema in teens and adults

  A 52-week study will test tilrekimig against dupilumab and a placebo to see if it helps people 12 and older with moderate-to-severe atopic dermatitis.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.