Study of CM310 in Adolescent Subjects With Atopic Dermatis

Phase 3

Active, not recruiting

• Conditions: Atopic Dermatitis
• Interventions: Biological: CM310

• Registration Number: NCT06495229
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

This is a multi-center, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-02
• Study First Posted: 2024-07-10
• Study Start: 2024-08-02
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-27
• Last Update Posted: 2025-10-02
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
• Subjects who must complete the evaluation of Week 18 of the main study.
• With Atopic Dermatitis.

Exclusion Criteria

• Any major surgery planned during the research period.
• Subjects with potential fertility do not agree to adopt efficient contraceptive measures throughout the entire study period; Pregnant or breastfeeding women, or women planning to conceive or breastfeed during the study period.
• With any circumstance that the subject is not suitable to participate in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CM310 group	CM310	-

Primary Outcome Measures

Name	Time	Method
Adverse events	up to week 52	Incidence of adverse events.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Eczema Area and Severity Index (EASI)	up to week 62	Changes from baseline in Eczema Area and Severity Index (EASI)
Proportion of subjects with Immunoglobulin A(IGA) 0 or 1 and a reduction of from baseline of ≥ 2 points	up to week 62	Proportion of subjects with IGA 0 or 1 (on a 5-point scale, range from 0-4 point, higher scores mean a worse disease severity) and reduction ≥2 points from baseline.
Improvement of Numerical Rating Scale (NRS)	up to week 62	Proportion of subjects with improvement (reduction) of pruritus NRS from baseline. The range of NRS is from 0 (no itch)-10 (worst imaginable itch).
Body surface area (BSA) of involvement of atopic dermatitis	up to week 62	Change from baseline in percent of BSA
Children Dermatology Life Quality Index (CDLQI)	up to week 62	Changes from baseline in CDLQI
Patient-Oriented Eczema Measure (POEM)	up to week 62	Changes from baseline in POEM
EuroQol Five Dimensions Questionnaire (EQ-5D)	up to week 62	Changes from baseline in EQ-5D
Pharmacokinetics parameters	up to week 62	Trough concentration and exposure of CM310
Immunogenicity	up to week 62	Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)

Trial Locations

Locations (1)

Peking University People's hospital; 🇨🇳 Beijing, China