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

NCT ID: NCT06162507

Last Updated: 2024-10-15

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

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-22

Study Completion Date

2024-07-04

Brief Summary

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This is a multi-center, single arm, open-label study to evaluate safety 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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CM310 group A

CM310 injection, subcutaneous injection, once every 3 weeks.

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

CM310 injection

CM310 group B

CM310 injection, subcutaneous injection, once every 2 weeks.

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

CM310 injection

Interventions

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CM310

CM310 injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* With atopic dermatis.
* Voluntarily sign the informed consent form.

Exclusion Criteria

* Any major surgery planned during the research period.
* With intestinal parasitic infection within the first 6 months of screening.
* With any previous malignant tumors prior to screening.
* With any circumstance that is not suitable to participate in this study.
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 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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CM310-101010

Identifier Type: -

Identifier Source: org_study_id

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