Overview

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

Status:
Not yet recruiting

Trial end date:
2024-04-01

Target enrollment:
0

Participant gender:
All

Summary

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. 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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Keymed Biosciences Co.Ltd

Criteria

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.