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

Keymed Biosciences Co.Ltd1 site in 1 country160 target enrollmentMarch 10, 2023

ConditionsAtopic Dermatitis

InterventionsCM310

DrugsCM310

Overview

Phase: Phase 2
Intervention: CM310
Conditions: Atopic Dermatitis
Sponsor: Keymed Biosciences Co.Ltd
Enrollment: 160
Locations: 1
Primary Endpoint: Proportion of subjects achieving EASI-75
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 10, 2023

End Date

July 18, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Keymed Biosciences Co.Ltd

Responsible Party

Sponsor

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.