Study of CM310 in Adolescent Subjects With Atopic Dermatis

September 27, 2025 updated by: Keymed Biosciences Co.Ltd

A Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of CM310 in Adolescent Patients With Atopic Dermatitis

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CM310 group
Biological: CM310
Interleukin-4 receptor(IL-4Rα) monoclonal antibody

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Eczema Area and Severity Index (EASI)
Time Frame: up to week 62
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
Time Frame: up to week 62
Proportion of subjects with IGA 0 or 1 (on a 5-point scale, range from 0-4 point, higher scores mean a worse disease severity) and reduction ≥2 points from baseline.
up to week 62
Improvement of Numerical Rating Scale (NRS)
Time Frame: up to week 62
Proportion of subjects with improvement (reduction) of pruritus NRS from baseline. The range of NRS is from 0 (no itch)-10 (worst imaginable itch).
up to week 62
Body surface area (BSA) of involvement of atopic dermatitis
Time Frame: up to week 62
Change from baseline in percent of BSA
up to week 62
Children Dermatology Life Quality Index (CDLQI)
Time Frame: up to week 62
Changes from baseline in CDLQI
up to week 62
Patient-Oriented Eczema Measure (POEM)
Time Frame: up to week 62
Changes from baseline in POEM
up to week 62
EuroQol Five Dimensions Questionnaire (EQ-5D)
Time Frame: up to week 62
Changes from baseline in EQ-5D
up to week 62
Pharmacokinetics parameters
Time Frame: up to week 62
Trough concentration and exposure of CM310
up to week 62
Immunogenicity
Time Frame: up to week 62
Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)
up to week 62

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keymed Biosciences Co.Ltd

Investigators

  • Principal Investigator: Jianzhong Zhang, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 2, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 27, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM310-101215

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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