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

Keymed Biosciences

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: CM310

Study type: Interventional

Funder types: Industry

Identifiers

NCT05579925

CM310-101108

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

CM310

Experimental group

Description:

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

Treatment:

Biological: CM310