Back to resultsThe Study of CM326 in Adult Subjects With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CM326
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
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.
Sites / Locations
- Peking University People's hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CM326
Arm Description
CM326 injection, subcutaneous (SC)
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent Adverse events related to CM326
Secondary Outcome Measures
Full Information
NCT ID
NCT05671445
First Posted
December 26, 2022
Last Updated
July 28, 2023
Sponsor
Keymed Biosciences Co.Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05671445
Brief Title
The Study of CM326 in Adult Subjects With Atopic Dermatitis
Official Title
An Open, Multineutral Study Evaluating the Safety and Efficacy of CM326 in the Long-term Treatment of Adult Subjects With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
March 28, 2024 (Anticipated)
Study Completion Date
March 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keymed Biosciences Co.Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CM326
Arm Type
Experimental
Arm Description
CM326 injection, subcutaneous (SC)
Intervention Type
Biological
Intervention Name(s)
CM326
Intervention Description
CM326 injection
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Description
Incidence of treatment-emergent Adverse events related to CM326
Time Frame
at week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Jia
Phone
+862888610620
Email
qianjia@keymedbio.com
Facility Information:
Facility Name
Peking University People's hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianzhong Zhang
12. IPD Sharing Statement
Learn more about this trial
The Study of CM326 in Adult Subjects With Atopic Dermatitis
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