Study of CM310 in Adolescent Subjects With Atopic Dermatis | NCT06495229

Studies
Study of CM310 in Adolescent Subjects With Atopic Dermatis

NCT06495229

Sponsor

Keymed Biosciences Co.Ltd

Status

Active, not recruiting

Last Update Posted

Oct 2, 2025Actual

Enrollment

180Estimated

Phase

Phase 3

Conditions

Atopic Dermatitis

Interventions

CM310

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2, 2024Actual

Primary Completion Date

Aug 30, 2026Estimated

Completion Date

Aug 30, 2026Estimated

First Submitted Date

Jul 2, 2024

First Submission Date that Met QC Criteria

Jul 2, 2024

First Posted Date

Jul 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2025

Last Update Posted Date

Oct 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a multi-center, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CM310 group	Experimental		Biological: CM310

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CM310	Biological	Interleukin-4 receptor(IL-4Rα) monoclonal antibody	CM310 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events	Incidence of adverse events.	up to week 52

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in Eczema Area and Severity Index (EASI)	Changes from baseline in Eczema Area and Severity Index (EASI)	up to week 62
Proportion of subjects with Immunoglobulin A(IGA) 0 or 1 and a reduction of from baseline of ≥ 2 points

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
Subjects who must complete the evaluation of Week 18 of the main study.
With Atopic Dermatitis.

Exclusion Criteria:

Any major surgery planned during the research period.
Subjects with potential fertility do not agree to adopt efficient contraceptive measures throughout the entire study period; Pregnant or breastfeeding women, or women planning to conceive or breastfeed during the study period.
With any circumstance that the subject is not suitable to participate in this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
jianzhong Zhang	Peking University People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's hospital		Beijing			China

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided