A Study of CM310 in Subjects 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

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-30

Study Completion Date

2026-03-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CM310

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

CM310, subcutaneous injection

Interventions

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CM310

CM310, subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No