The Study of CM326 in Adult Subjects With Atopic Dermatitis

Phase 2

Recruiting

• Conditions: Atopic Dermatitis

• Registration Number: NCT05671445
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

This is a open-label, multi-center study to evaluate the safety and efficacy of CM326 in atopic adrmatitis 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

• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2022-12-31
• Study First Posted: 2023-01-04
• Study Start: 2023-02-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-03-28
• Study Completion: 2025-03-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

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