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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Biological: CM310

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Hangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; CM310, subcutaneous	Biological: CM310; IL-4Rα monoclonal antibody
Experimental: Group B; CM310, subcutaneous	Biological: CM310; IL-4Rα monoclonal antibody

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Keymed Biosciences Co.Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): July 18, 2024
• Study Completion (Actual): July 18, 2024

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: CM310-101109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No