A Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of CM310 in Adolescent Patients With Atopic Dermatitis

Keymed Biosciences Co.Ltd1 site in 1 country180 target enrollmentAugust 2, 2024

ConditionsAtopic Dermatitis

InterventionsCM310

Overview

Phase: Phase 3
Intervention: CM310
Conditions: Atopic Dermatitis
Sponsor: Keymed Biosciences Co.Ltd
Enrollment: 180
Locations: 1
Primary Endpoint: Adverse events
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2, 2024

End Date

August 30, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Keymed Biosciences Co.Ltd

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

CM310 group

Intervention: CM310

Outcomes

Primary Outcomes

Adverse events

Time Frame: up to week 52

Incidence of adverse events.

Secondary Outcomes

Change from baseline in Eczema Area and Severity Index (EASI)(up to week 62)
Proportion of subjects with Immunoglobulin A(IGA) 0 or 1 and a reduction of from baseline of ≥ 2 points(up to week 62)
Improvement of Numerical Rating Scale (NRS)(up to week 62)
Body surface area (BSA) of involvement of atopic dermatitis(up to week 62)
Children Dermatology Life Quality Index (CDLQI)(up to week 62)
Patient-Oriented Eczema Measure (POEM)(up to week 62)
EuroQol Five Dimensions Questionnaire (EQ-5D)(up to week 62)
Pharmacokinetics parameters(up to week 62)
Immunogenicity(up to week 62)