This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial, aiming to evaluate the efficacy, safety, and tolerability of CMS-D001 in participants with moderate to severe atopic dermatitis, as well as to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of CMS-D001 and its major metabolites (as applicable) in participants with moderate to severe atopic dermatitis, so as to provide a basis for the dosage of the Phase III confirmatory clinical trial.
Aged 18-75 years, willing to sign the ICF
Clinical diagnosis of AD (Hanifin & Rajka criteria) for ≥1 year
At screening and baseline, EASI score ≥ 16 points, IGA ≥ 3, BSA ≥ 10%, Itch NRS ≥ 4
Documented history of inadequate response to topical corticosteroids (TCS) or -topical calcineurin inhibitors (TCI).
Other active skin conditions that may interfere with AD assessment.
History of a serious bacterial, fungal, or viral infection requiring hospitalization or intravenous antimicrobial therapy within 3 months prior to the first dose.
History of a bacterial, fungal, or viral infection requiring oral antimicrobial therapy within 4 weeks prior to the first dose.
Active infection or acute illness within 7 days prior to the first dose.
Parallel
CMS-D001 50mg
DrugCMS-D001 50mg QD
CMS-D001 100mg
DrugCMS-D001 100mg QD
CMS-D001 200mg
DrugCMS-D001 200mg QD
Placebo
DrugPlacebo QD
Number of participants achieving at least 75% improvement in Eczema Area and Severity Index (EASI 75)
Number of participants achieving at least 75% improvement in EASI (EASI 75)
Number of participants achieving at least 50% or 90% improvement in EASI (EASI 50/90)
Number of participants achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline
Number of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1
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This trial is not recruiting at the moment. You can still explore other options:
