Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

Keymed Biosciences Co.Ltd120 enrolled

Overview

This is a multi-center, randomized, double blind, placebo-controlled phase IIb study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in moderate-severe AD subjects. The study consists of 3 periods, a up-to-4-week Screening Period, a 16-week randomized Treatment Period and a 8-week Safety Follow-up Period.

Subjects will be required to apply moisturizers after ICF signed and continue throughout the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Moderate-to-severe Atopic Dermatitis

Interventions

CM310BIOLOGICAL

IL-4Rα monoclonal antibody

PlaceboBIOLOGICAL

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed as AD for at least 12 months before Screening, with below requirements: 1)EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 (0-5 points scale) at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline. * Inadequate response to topical medications. Exclusion Criteria: * Not enough washing-out period for previous therapy. * Concurrent disease/status which may potentially affect the efficacy/safety judgement. * Organ dysfunction. * pregnancy. * Other.

Locations (25)

Beijing Chao-Yang Hospital, Capital Medical University

Outcomes

Primary Outcomes

EASI-75

Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)

Time frame: at Week 16

Secondary Outcomes

Investigator's Global Assessment (IGA) 0/1

Proportion of subjects with IGA 0 or 1 (on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) and a reduction from baseline of ≥2 points.

Time frame: at week 16

reduction of IGA from baseline of ≥ 2 points

Proportion of subjects with IGA 0 or 1 (on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) and a reduction from baseline of ≥2 points.

Time frame: at week 16

The Eczema Area and Severity Index (EASI)-90

Proportion of subjects with EASI-90 (≥90 percent improvement from baseline)

Time frame: at week 16

The Eczema Area and Severity Index (EASI)-50

Proportion of subjects with EASI-50 (≥50 percent improvement from baseline)

Time frame: at week 16

Improvement of Numerical Rating Scale (NRS)

Proportion of subjects with improvement (reduction) of pruritus NRS of ≥4 points from baseline. The range of NRS is from 0 (no itch)-10 (worst imaginable itch).

Time frame: at week 16

Body Surface Area (BSA)

Change from baseline in percent of BSA

Time frame: Baseline to Week 24

Dermatology Life Quality Index (DLQI)

Data from ClinicalTrials.gov

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