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NCT Number: NCT05715320

Study of CM310 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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM310

Biological

IL-4Rα monoclonal antibody

Primary outcomes

  1. Proportion of subjects achieving EASI-75

    Time frame: up to week 12

    Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score).

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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