The Study of CM326 in Moderate-to-severe Atopic Dermatitis

Keymed Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Moderate-to-severe Atopic Dermatitis

Treatments: Biological: CM326; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05671432

CM326-101102

Details and patient eligibility

About

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis 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: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With confirmed Atopic Dermatitis (AD) at the screening.
• Age ≥ 18 years and ≤ 75 years, male or female.
• 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.

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: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups, including a placebo group

Group A

Experimental group

Description:

Group A: CM326, subcutaneous (SC)

Treatment:

Biological: CM326

Group B

Experimental group

Description:

Group A: CM326, subcutaneous (SC)

Treatment:

Biological: CM326

Group C

Placebo Comparator group

Description:

Group C: placebo, subcutaneous (SC)

Treatment:

Other: Placebo