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NCT05715320
Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis
Conditions: Atopic Dermatitis
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE2
Enrollment: 160
Sponsor: Keymed Biosciences Co.Ltd
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05715320). StuddyBuddy aggregates publicly available trial information.