Study of CM310 in Adolescent Subjects With Atopic Dermatis

NCT ID: NCT06495229

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-02

Study Completion Date

2026-08-30

Brief Summary

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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

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CM310 group

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

Interleukin-4 receptor(IL-4Rα) monoclonal antibody

Interventions

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CM310

Interleukin-4 receptor(IL-4Rα) monoclonal antibody

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jianzhong Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People's hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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CM310-101215

Identifier Type: -

Identifier Source: org_study_id

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