ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis
ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
About this trial
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
Eligibility criteria
Qualifiers
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.
Eczema Area and Severity Index (EASI) score ≥ 16 ;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ICP-332 Tablets
- ICP-332 Placebo Tablets
Treatment groups
552 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov