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.
Approximately 160 participants with moderate to severe atopic dermatitis are planned to be enrolled and randomly assigned to four groups in a 1:1:1:1 ratio. Stratification will be performed based on participants' baseline IGA scores (3 or 4) at the time of randomization. Each participant will receive study treatment once daily (QD) for 12 consecutive weeks. The dosage and frequency for each group are as follows: Trial Group 1: CMS-D001 50 mg, QD; Trial Group 2: CMS-D001 100 mg, QD; Trial Group 3: CMS-D001 200 mg, QD; Control Group: Placebo, QD. The study is divided into three phases: a Screening Period (up to 4 weeks), a Treatment Period (12 weeks), and a Safety Follow-up Period (4 weeks after the last dose). During the study, all participants must adhere to the study visit schedule to undergo efficacy and safety assessments. They will also be required to complete blood sample collections for Pharmacokinetic (PK) and Pharmacodynamic (PD) evaluations, and information regarding Adverse Events (AEs) and concomitant medications will be collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
CMS-D001 50mg QD
CMS-D001 100mg QD
CMS-D001 200mg QD
Placebo QD
Beijing Huairou Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong, China
Number of participants achieving at least 75% improvement in Eczema Area and Severity Index (EASI 75)
Time frame: At week 12
Number of participants achieving at least 75% improvement in EASI (EASI 75)
Time frame: At weeks 2, 4, 8
Number of participants achieving at least 50% or 90% improvement in EASI (EASI 50/90)
Time frame: At weeks 2, 4, 8, 12
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
Time frame: At weeks 2, 4, 8, 12
Number of participants achieving an Investigator's Global Assessment (IGA) score of 0 or 1
Time frame: At weeks 2, 4, 8, 12
Number of participants achieving at least a 4-point reduction in Itch Numeric Rating Scale (Itch NRS) score from baseline
Time frame: At weeks 2, 4, 8, 12
Percentage change in EASI score from baseline
Time frame: At weeks 2, 4, 8, 12
Percentage change in SCORing Atopic Dermatitis (SCORAD) score from baseline
Time frame: At weeks 2, 4, 8, 12
Change in Itch Numeric Rating Scale (Itch NRS) score from baseline
Time frame: At weeks 2, 4, 8, 12
Percentage change in affected Body Surface Area (BSA) from baseline
Time frame: At weeks 2, 4, 8, 12
Change in Dermatology Life Quality Index (DLQI) score from baseline
Time frame: At weeks 2, 4, 8, 12
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Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Hainan Provincial Fifth People's Hospital
Haikou, Hainan, China
Hebei Medical University Second Hospital
Shijiazhuang, Hebei, China
Affiliated Hospital of North China University of Science and Technology
Tangshan, Hebei, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
...and 18 more locations