The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis

A Randomized, Double Blind, Placebo-Controlled, Multiple Dose Escalation, Phase 2 Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Efficacy of CM326 in Patients With Moderate-severe Atopic Dermatitis Subjects

This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of CM326 in moderate-severe AD subjects.

The study consists of 3 periods, a up-to-4-week Screening Period, a 12-week randomized Treatment Period and a 12-week Safety Follow-up Period.

Inclusion Criteria:

• With confirmed Atopic Dermatitis (AD) at least 12 months before the screening
• Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline
• Investigator's Global Assessment (IGA) score ≥3 at screening and baseline
• Body Surface Area (BSA) of involvement of atopic dermatitis ≥10% at screening and baseline
• The weekly mean score of daily peaks in pruritus NRS at baseline ≥4
• Provide signed informed consent

Exclusion Criteria:

• Not enough washing-out period for previous therapy.
• Presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or parasitosis, neoplasm malignant, etc.
• Patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times of upper limit of normal (ULN), total bilirubin >1.5 times of upper limit of normal (ULN) or serum creatinine level > upper limit of normal (ULN).
• Womens who are pregnant or breastfeeding, or who plan to become pregnant during the study.