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

Keymed Biosciences

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Other: Placebo; Drug: CM310

Study type: Interventional

Funder types: Industry

Identifiers

NCT05265923

CM310AD005

Details and patient eligibility

About

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in patients with moderate-to-severe atopic dermatitis.

Full description

The study consists of an up-to-4-week screening period, a 16-week double-blind treatment period, a 36-week maintenance treatment period, and a 8-week safety follow-up period.

Enrollment: 500 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with AD for at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.

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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500 participants in 2 patient groups, including a placebo group

CM310

Experimental group

Description:

CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W)

Treatment:

Drug: CM310

Placebo

Placebo Comparator group

Description:

Double blind treatment period : Placebo Maintenance treatment period : CM310, 600mg for the initial dose, and 300mg for subsequent doses, subcutaneous injection (SC), every 2 weeks (Q2W)

Treatment:

Drug: CM310

Other: Placebo