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

Keymed Biosciences

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: CM310

Study type: Interventional

Funder types: Industry

Identifiers

NCT05715320

CM310-101109

Details and patient eligibility

About

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.

Full description

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

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups

Group A

Experimental group

Description:

CM310, subcutaneous

Treatment:

Biological: CM310

Group B

Experimental group

Description:

CM310, subcutaneous

Treatment:

Biological: CM310