Back to resultsStudy of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CM310
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria: Have the ability to understand the study and voluntarily sign a written ICF. Age ≥ 18 and ≤ 75 years old, male or female. The fertile subjects agreed to take effective contraceptive measures throughout the study period. The subjects can communicate well with the investigators and complete the follow-up according to the protocol. Exclusion Criteria: Live vaccine or attenuated live vaccine has been vaccinated or planned to be vaccinated within 12 weeks before randomization. He received allergen-specific immunotherapy (desensitization therapy) within 6 months before randomization. Major surgery is planned during the study period. Previous history of atopic keratoconjunctivitis and corneal involvement. Other combined skin diseases that may affect the evaluation of the study. Confronting IL-4R α Monoclonal antibody or CM310/placebo drug or ingredient allergy.
Sites / Locations
- Hangzhou First People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
CM310, subcutaneous
CM310, subcutaneous
Outcomes
Primary Outcome Measures
Proportion of subjects achieving EASI-75
Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score).
Secondary Outcome Measures
Full Information
NCT ID
NCT05715320
First Posted
January 27, 2023
Last Updated
July 28, 2023
Sponsor
Keymed Biosciences Co.Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05715320
Brief Title
Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis
Official Title
A Randomized, Double Blind, Parallel-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate-to-severe Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 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 study is a multi-center, randomized, double-blind, parallel controlled phase 2 study, aimed at evaluating the efficacy and safety of CM310 in the treatment of patients with moderate-to-severe atopic dermatitis, and observing Pharmacokinetics characteristics, Pharmacodynamics effects and immunogenicity.
Detailed Description
This study includes screening, treatment and follow-up periods. 160 subjects will be enrolled to receive CM310.
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
CM310, subcutaneous
Arm Title
Group B
Arm Type
Experimental
Arm Description
CM310, subcutaneous
Intervention Type
Biological
Intervention Name(s)
CM310
Intervention Description
IL-4Rα monoclonal antibody
Primary Outcome Measure Information:
Title
Proportion of subjects achieving EASI-75
Description
Proportion of subjects achieving EASI-75 (≥75% reduction from baseline in Eczema Area and Severity Index score).
Time Frame
up to week 12
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:
Have the ability to understand the study and voluntarily sign a written ICF.
Age ≥ 18 and ≤ 75 years old, male or female.
The fertile subjects agreed to take effective contraceptive measures throughout the study period.
The subjects can communicate well with the investigators and complete the follow-up according to the protocol.
Exclusion Criteria:
Live vaccine or attenuated live vaccine has been vaccinated or planned to be vaccinated within 12 weeks before randomization.
He received allergen-specific immunotherapy (desensitization therapy) within 6 months before randomization.
Major surgery is planned during the study period.
Previous history of atopic keratoconjunctivitis and corneal involvement.
Other combined skin diseases that may affect the evaluation of the study.
Confronting IL-4R α Monoclonal antibody or CM310/placebo drug or ingredient allergy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Jia
Phone
028-88610620
Email
qianjia@keymedbio.com
Facility Information:
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liming Wu
12. IPD Sharing Statement
Learn more about this trial
Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis
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