Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

• Status: Completed
• Trial end date: 2021-01-22
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously CM310 in moderate-severe AD subjects.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keymed Biosciences Co.Ltd

Criteria

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.