A Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis

NCT ID: NCT05579925

Last Updated: 2024-11-08

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-07

Study Completion Date

2023-07-28

Brief Summary

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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.

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

600 mg + 300 mg, subcutaneous injection, once every two weeks

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

CM310 600 mg + 300 mg, subcutaneous injection

Interventions

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CM310

CM310 600 mg + 300 mg, subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
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

Locations

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Beijing Children's Hospital Capital Medical University

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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CM310-101108

Identifier Type: -

Identifier Source: org_study_id

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