Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

Keymed Biosciences Co.Ltd180 enrolled

Overview

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

Conditions

Atopic Dermatitis

Interventions

CM310BIOLOGICAL

Interleukin-4 receptor(IL-4Rα) monoclonal antibody

placeboOTHER

Placebo

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have the ability to understand the study and voluntarily sign a written informed consent form (ICF). * With Atopic Dermatitis. Exclusion Criteria: * Not enough washing-out period for previous therapies. * Any major surgery planned during the research period. * With intestinal parasitic infection within the 6 months before screening. * With any circumstance that is not suitable to participate in this study. * Major surgeries are planned during the study period.

Locations (1)

Peking University People's hospital

Beijing, China

Outcomes

Primary Outcomes

Proportion of subjects achieving EASI-75 at week 18

The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe).

Time frame: Up to week 18

Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline

Proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 18. IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Time frame: up to week 18

Secondary Outcomes

Percent change of Eczema Area and Severity Index (EASI) score from baseline

The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).

Time frame: up to week 18

Percent change of NRS score from baseline

The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch)

Time frame: up to week 18

Body surface area (BSA) of involvement of atopic dermatitis

Change from baseline in percent of BSA

Time frame: up to week 18

Children Dermatology Life Quality Index (CDLQI)

Changes from baseline in CDLQI

Data from ClinicalTrials.gov

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