Back to resultsA Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis
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:
- 12 years ≤ age ≤ 18 years
- With atopic dermatis
- Voluntarily sign the informed consent form
Exclusion Criteria:
- Weight < 30 kg
- Major surgery planed during the study
Sites / Locations
- Beijing Children's Hospital Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CM310
Arm Description
600 mg + 300 mg, subcutaneous injection, once every two weeks
Outcomes
Primary Outcome Measures
Adverse events
Incidence of adverse events.
Secondary Outcome Measures
Full Information
NCT ID
NCT05579925
First Posted
October 11, 2022
Last Updated
December 31, 2022
Sponsor
Keymed Biosciences Co.Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05579925
Brief Title
A Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis
Official Title
A Multicenter, Single-arm, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetics of CM310 in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (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, single arm, open-label study to evaluate safety and primary efficacy in children patients with moderate-to severe atopic dermatis.
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
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CM310
Arm Type
Experimental
Arm Description
600 mg + 300 mg, subcutaneous injection, once every two weeks
Intervention Type
Biological
Intervention Name(s)
CM310
Intervention Description
CM310 600 mg + 300 mg, subcutaneous injection
Primary Outcome Measure Information:
Title
Adverse events
Description
Incidence of adverse events.
Time Frame
at week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
12 years ≤ age ≤ 18 years
With atopic dermatis
Voluntarily sign the informed consent form
Exclusion Criteria:
Weight < 30 kg
Major surgery planed during the study
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
Beijing Children's Hospital Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Ma
12. IPD Sharing Statement
Learn more about this trial
A Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis
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