CM310 for Eczema

Phase 2

Waitlist Available

Research Sponsored by Keymed Biosciences Co.Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This is an open, multicenter, extension study evaluating the safety and efficacy of CM310 for long-term treatment in patients with atopic dermatitis The primary objective is to assess the long-term safety of CM310 administered in patients with atopic dermatitis (AD).

Eligible Conditions

Eczema

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Treatment Emergent Adverse Events (TEAEs)

Secondary study objectives

Body Surface Area (BSA)

Change from baseline in EASI score at each visit

Changes from baseline to prespecified time points through the end of the study: Dermatology Life Quality Index (DLQI)

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CM310Experimental Treatment1 Intervention

adults and teenagers (12 \~ 18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC. teenagers (12 \~ 18 years) with weight ≥30 kg and \<60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CM310

2022

Completed Phase 3

~1810

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