A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis

Keymed Biosciences Co.Ltd263 enrolled

Overview

This is a multi-center, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.

The study consists of an screening period, treatment period, and safety follow-up period.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

263

Conditions

Atopic Dermatitis

Interventions

CM310BIOLOGICAL

CM310, subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have the ability to understand the study and voluntarily sign a written informed consent form (ICF). * Age ≥ 18 and ≤ 75 years old. * With Atopic Dermatitis. Exclusion Criteria: * Not enough washing-out period for previous therapy. * Concurrent disease/status which may potentially affect the efficacy/safety judgement. * Major surgeries are planned during the study period.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Adverse events (AEs)

Incidence of adverse events (AEs).

Time frame: up to Week 60

Secondary Outcomes

Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 0 at each scheduled assessment visit

Time frame: up to Week 60

Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 1 at each scheduled assessment visit

Time frame: up to Week 60

Percentage of subjects achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) at each scheduled assessment visit

Time frame: up to Week 60

Percentage of subjects achieving ≥90% improvement from baseline in the Eczema Area and Severity Index (EASI-90) at each scheduled assessment visit

Time frame: up to Week 60

Change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit

Time frame: up to Week 60

Percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit

Time frame: up to Week 60

Change and percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit

Time frame: up to Week 60

Percentage of subjects achieving a ≥4-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores

Data from ClinicalTrials.gov

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