A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis

Last updated: November 6, 2024
Sponsor: Keymed Biosciences Co.Ltd
Overall Status: Completed

Phase

3

Condition

Allergy

Atopic Dermatitis

Eczema (Atopic Dermatitis)

Treatment

Placebo

CM310

Clinical Study ID

NCT05265923
CM310AD005
  • Ages 18-75
  • All Genders

Study Summary

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in patients with moderate-to-severe atopic dermatitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with AD for at least 12 months before Screening, with below requirements:
  1. EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening andBaseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRSaverage score ≥3 at Baseline.

Exclusion

Exclusion Criteria:

  • Not enough washing-out period for previous therapy.

  • Concurrent disease/status which may potentially affect the efficacy/safetyjudgement.

  • Organ dysfunction.

  • pregnancy.

  • Other.

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 22, 2022
Estimated Completion Date:
December 25, 2023

Study Description

The study consists of an up-to-4-week screening period, a 16-week double-blind treatment period, a 36-week maintenance treatment period, and a 8-week safety follow-up period.

Connect with a study center

  • Peking University People's hospital

    Beijing,
    China

    Site Not Available

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