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NCT05671445 Clinical Trial

The Study of CM326 in Adult Subjects With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:
An Open, Multineutral Study Evaluating the Safety and Efficacy of CM326 in the Long-term Treatment of Adult Subjects With Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05671445
Other study ID # CM326-101105
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 9, 2023
Est. completion date March 28, 2025

Study information
Verified date March 2023
Source Keymed Biosciences Co.Ltd
Contact Qian Jia
Phone +862888610620
Email qianjia@keymedbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a open-label, multi-center study to evaluate the safety and efficacy of CM326 in atopic adrmatitis 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 100
Est. completion date March 28, 2025
Est. primary completion date March 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - With confirmed Atopic Dermatitis (AD) at the screening. - 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. - The subjects agreed to use highly effective contraceptive measures during the study. 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

Related Conditions & MeSH terms

Intervention

Biological:
• CM326
CM326 injection

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 Incidence of treatment-emergent adverse events Incidence of treatment-emergent Adverse events related to CM326 at week 52
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