Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis

A Randomized, Double Blind, Parallel-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate-to-severe Atopic Dermatitis

This study is a multi-center, randomized, double-blind, parallel controlled phase 2 study, aimed at evaluating the efficacy and safety of CM310 in the treatment of patients with moderate-to-severe atopic dermatitis, and observing Pharmacokinetics characteristics, Pharmacodynamics effects and immunogenicity.

This study includes screening, treatment and follow-up periods. 160 subjects will be enrolled to receive CM310.

Inclusion Criteria:

• Have the ability to understand the study and voluntarily sign a written ICF.
• Age ≥ 18 and ≤ 75 years old, male or female.
• The fertile subjects agreed to take effective contraceptive measures throughout the study period.
• The subjects can communicate well with the investigators and complete the follow-up according to the protocol.

Exclusion Criteria:

• Live vaccine or attenuated live vaccine has been vaccinated or planned to be vaccinated within 12 weeks before randomization.
• He received allergen-specific immunotherapy (desensitization therapy) within 6 months before randomization.
• Major surgery is planned during the study period.
• Previous history of atopic keratoconjunctivitis and corneal involvement.
• Other combined skin diseases that may affect the evaluation of the study.
• Confronting IL-4R α Monoclonal antibody or CM310/placebo drug or ingredient allergy.