Status:
COMPLETED
Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Moderate-to-severe Atopic Dermatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized Treatment Period and a 8-week Safety Follow-up Period.
Eligibility Criteria
Inclusion
- 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
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Organ dysfunction.
- Pregnancy.
- Other.
Key Trial Info
Start Date :
July 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04893941
Start Date
July 21 2020
End Date
January 22 2021
Last Update
June 4 2021
Active Locations (7)
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1
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
2
Wuxi Second Hospital
Wuxi, Jiangsu, China
3
West China Hospital of Sichuan University
Chengdu, Sichuan, China
4
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China