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

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Biological: CM310

• Registration Number: NCT06162507
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

This is a multi-center, single arm, open-label study to evaluate safety in children patients with moderate-to severe atopic dermatis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-08
• Study Start: 2023-12-22
• Primary Completion: 2024-07-04
• Study Completion: 2024-07-04
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CM310 group A	CM310	CM310 injection, subcutaneous injection, once every 3 weeks.
CM310 group B	CM310	CM310 injection, subcutaneous injection, once every 2 weeks.

Primary Outcome Measures

Name	Time	Method
Adverse events	up to week 16	Incidence of adverse events.

Trial Locations

Locations (1)

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