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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-22

Study Completion Date

2023-12-25

Brief Summary

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

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Detailed Description

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The study consists of an up-to-4-week screening period, a 16-week double-blind treatment period, a 36-week maintenance treatment period, and a 8-week safety follow-up period.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CM310

CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W)

Group Type EXPERIMENTAL

CM310

Intervention Type DRUG

IL-4Rα monoclonal antibody

Placebo

Double blind treatment period : Placebo

Maintenance treatment period : CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W)

Group Type PLACEBO_COMPARATOR

CM310

Intervention Type DRUG

IL-4Rα monoclonal antibody

Placebo

Intervention Type OTHER

Placebo

Interventions

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CM310

IL-4Rα monoclonal antibody

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with AD for at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No