Back to resultsThe Study of CM326 in Moderate-to-severe Atopic Dermatitis
Primary Purpose
Moderate-to-severe Atopic Dermatitis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CM326
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Moderate-to-severe Atopic Dermatitis
Eligibility Criteria
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.
Sites / Locations
- Peking University People's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Group A: CM326, subcutaneous (SC)
Group A: CM326, subcutaneous (SC)
Group C: placebo, subcutaneous (SC)
Outcomes
Primary Outcome Measures
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
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05671432
First Posted
December 26, 2022
Last Updated
December 31, 2022
Sponsor
Keymed Biosciences Co.Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05671432
Brief Title
The Study of CM326 in Moderate-to-severe Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2022 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate-to-severe Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A: CM326, subcutaneous (SC)
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group A: CM326, subcutaneous (SC)
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Group C: placebo, subcutaneous (SC)
Intervention Type
Biological
Intervention Name(s)
CM326
Intervention Description
CM326 injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 16
Description
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
Time Frame
at week 16
Title
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and reduction from baseline of ≥2 points at Visit 16
Description
IGA is a 5-point scale ranging from 0 (clear) to 4 (very severe)
Time Frame
at week 16
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.
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.
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
Plan to Share IPD
No
Learn more about this trial
The Study of CM326 in Moderate-to-severe Atopic Dermatitis
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