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

Moderate-to-severe Atopic Dermatitis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM326 Injection in the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671432
• Other study ID #: CM326-101102
• Status: Recruiting
• Phase: Phase 2
• Start date: December 27, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2022
• Source: Keymed Biosciences Co.Ltd
• Contact: Qian Jia
• Phone: +862888610620
• Email: qianjia[@]keymedbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate-to-severe Atopic Dermatitis

Intervention

Biological:
• CM326
CM326 injection

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
China	Peking University People's hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with Eczema Area and Severity Index (EASI)-75 (=75 percent reduction in EASI scores from baseline) at visit 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	at week 16
Primary	Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and reduction from baseline of =2 points at Visit 16	IGA is a 5-point scale ranging from 0 (clear) to 4 (very severe)	at week 16