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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Biological: CM310

• Registration Number: NCT05715320
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief 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.

Detailed Description

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

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-01-27
• Study First Posted: 2023-02-08
• Study Start: 2023-03-10
• Primary Completion: 2024-07-18
• Study Completion: 2024-07-18
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	CM310	CM310, subcutaneous
Group A	CM310	CM310, subcutaneous

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving EASI-75	up to week 12	Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score).

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China