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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05715320

Enrollment

160

Registered

2023-02-08

Start date

2023-03-10

Completion date

2024-07-18

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

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.

Interventions

BIOLOGICALCM310

IL-4Rα monoclonal antibody

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of subjects achieving EASI-75	up to week 12	Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026