Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

Keymed Biosciences

Status and phase: Completed; Phase 2

Conditions: Moderate-to-severe Atopic Dermatitis

Treatments: Biological: Placebo; Biological: CM310

Study type: Interventional

Funder types: Industry

Identifiers

NCT04805411

CM310AD002

Details and patient eligibility

About

This is a multi-center, randomized, double blind, placebo-controlled phase IIb study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in moderate-severe AD subjects. The study consists of 3 periods, a up-to-4-week Screening Period, a 16-week randomized Treatment Period and a 8-week Safety Follow-up Period.

Full description

Subjects will be required to apply moisturizers after ICF signed and continue throughout the study.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed as AD for at least 12 months before Screening, with below requirements: 1)EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 (0-5 points scale) at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
• Inadequate response to topical medications.

Exclusion criteria

• Not enough washing-out period for previous therapy.
• Concurrent disease/status which may potentially affect the efficacy/safety judgement.
• Organ dysfunction.
• pregnancy.
• Other.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

High-dose arm

Experimental group

Description:

600mg for 1st dose, and then 300 mg for 2-8nd doses, every 2 weeks, SC

Treatment:

Biological: CM310

low-dose arm

Experimental group

Description:

300mg for 1st dose, and then 150 mg for 2-8nd doses, every 2 weeks, SC

Treatment:

Biological: CM310

placebo

Placebo Comparator group

Description:

placebo for 1-8 doses, every 2 weeks, SC

Treatment:

Biological: Placebo