The Study of CM326 in Moderate-to-severe Atopic Dermatitis

Phase 2

Recruiting

• Conditions: Moderate-to-severe Atopic Dermatitis
• Interventions: Biological: CM326; Other: Placebo

• Registration Number: NCT05671432
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis subjects.

Detailed Description

The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-26
• Study Start: 2022-12-27
• Study First Submitted QC: 2022-12-31
• Last Update Submitted: 2022-12-31
• Study First Posted: 2023-01-04
• Last Update Posted: 2023-01-04
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• With confirmed Atopic Dermatitis (AD) at the screening.
• Age ≥ 18 years and ≤ 75 years, male or female.
• Have the ability to understand the nature of the study and voluntarily sign the informed consent.
• Be able to communicate well with investigators and follow up protocol requirements.

Exclusion Criteria

• Not enough washing-out period for previous therapy.
• Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.
• Major surgery is planned during the study period.
• Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	CM326	Group A: CM326, subcutaneous (SC)
Group B	CM326	Group A: CM326, subcutaneous (SC)
Group C	Placebo	Group C: placebo, subcutaneous (SC)

Primary Outcome Measures

Name	Time	Method
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 16	at week 16	The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and reduction from baseline of ≥2 points at Visit 16	at week 16	IGA is a 5-point scale ranging from 0 (clear) to 4 (very severe)

Trial Locations

Locations (1)

Peking University People's hospital; 🇨🇳 Beijing, China