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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Biological: CM310

• Registration Number: NCT05579925
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

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

Not available

Study Timeline

• Study Start: 2022-10-07
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-14
• Status Verified: 2023-06
• Primary Completion: 2023-07-28
• Study Completion: 2023-07-28
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CM310	CM310	600 mg + 300 mg, subcutaneous injection, once every two weeks

Primary Outcome Measures

Name	Time	Method
Adverse events	at week 14	Incidence of adverse events.

Trial Locations

Locations (1)

Beijing Children's Hospital Capital Medical University; 🇨🇳 Beijing, China