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

Keymed Biosciences

Status and phase: Not yet enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: CM310

Study type: Interventional

Funder types: Industry

Identifiers

NCT06116565

CM310-101116

Details and patient eligibility

About

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.

Full description

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

CM310

Experimental group

Treatment:

Biological: CM310