The Study of CM326 in Adult Subjects With Atopic Dermatitis

Keymed Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: CM326

Study type: Interventional

Funder types: Industry

Identifiers

NCT05671445

CM326-101105

Details and patient eligibility

About

This is a open-label, multi-center study to evaluate the safety and efficacy of CM326 in atopic adrmatitis subjects.

Full description

The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With confirmed Atopic Dermatitis (AD) at the screening.
• Have the ability to understand the nature of the study and voluntarily sign the informed consent.
• Be able to communicate well with investigators and follow up protocol requirements.
• The subjects agreed to use highly effective contraceptive measures during the study.

Exclusion criteria

• Not enough washing-out period for previous therapy.
• Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.
• Major surgery is planned during the study period.
• Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

CM326

Experimental group

Description:

CM326 injection, subcutaneous (SC)

Treatment:

Biological: CM326