Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

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

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-21

Study Completion Date

2025-01-23

Brief Summary

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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.

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Detailed Description

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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 group

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

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

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Placebo

Interventions

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CM310

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

Intervention Type BIOLOGICAL

placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No