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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
ICP-332 Tablets
DrugICP-332 will be administered as tablet
ICP-332 Placebo Tablets
DrugICP-332 Placebo will be administered as tablet
Treatment groups
552 Participants
are divided into 2 treatment groupsGroup A: ICP-332Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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 weeks2
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 weeksSponsors and contacts
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Source ClinicalTrials.gov