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

Last updated: October 14, 2024
Sponsor: Keymed Biosciences Co.Ltd
Overall Status: Completed

Phase

2

Condition

Atopic Dermatitis

Eczema (Atopic Dermatitis)

Eczema (Atopic Dermatitis - Pediatric)

Treatment

CM310

Clinical Study ID

NCT05715320
CM310-101109
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thestudy period.

  • The subjects can communicate well with the investigators and complete the follow-upaccording to the protocol.

Exclusion

Exclusion Criteria:

  • Live vaccine or attenuated live vaccine has been vaccinated or planned to bevaccinated within 12 weeks before randomization.

  • He received allergen-specific immunotherapy (desensitization therapy) within 6months 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

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: CM310
Phase: 2
Study Start date:
March 10, 2023
Estimated Completion Date:
July 18, 2024

Study Description

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

Connect with a study center

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

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