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NCT06277765 Clinical Trial

Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

Atopic Dermatitis Clinical Trial

Official title:
A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Adolescent Patients With Moderate-to-severe Atopic Dermatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06277765
Other study ID # CM310-101212
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date May 30, 2024
Est. completion date May 30, 2025

Study information
Verified date January 2024
Source Keymed Biosciences Co.Ltd
Contact Qian Jia
Phone 028-88610620
Email qianjia@keymedbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 180
Est. completion date May 30, 2025
Est. primary completion date May 30, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - Have the ability to understand the study and voluntarily sign a written informed consent form (ICF). - With Atopic Dermatitis. Exclusion Criteria: - Not enough washing-out period for previous therapies. - Any major surgery planned during the research period. - With intestinal parasitic infection within the 6 months before screening. - With any circumstance that is not suitable to participate in this study. - Major surgeries are planned during the study period.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• CM310
IL-4Ra monoclonal antibody
Other:
• placebo
Placebo

Locations
Country Name City State
China Peking University People's hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of subjects achieving EASI-75 at week 18 The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe). Up to week 18
See also
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