Trial intelligence / Profile preview

Stapokibart in moderate-to-severe atopic dermatitis

NCT05715320Phase 2

Key facts

Status
Completed
Start
Mar 2023
Primary completion
Jul 2024
Countries
1
Modality
Monoclonal Antibodies
Conditions
atopic dermatitis (AD)
01

Overview

Phase 2, randomised, double-blind trial of stapokibart in atopic dermatitis (AD) (2 arms), sponsored by Keymed Biosciences. Primary endpoint: Proportion of subjects achieving EASI-75 at 12 weeks. Started Mar 2023; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Group A

    Stapokibart (CM310) subcutaneous

  • Group B

    Stapokibart (CM310) subcutaneous

03

Who it enrols

Adults aged 18-75 with moderate-to-severe atopic dermatitis, agreeing to contraception. Exclusion includes recent live vaccines (within 12 weeks), allergen-specific immunotherapy (within 6 months), major planned surgery, atopic keratoconjunctivitis/corneal involvement, or allergy to IL-4Rα antibodies.

04

Endpoints

Primary

  • Proportion of subjects achieving EASI-75

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