A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
NCT05604898 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 139
Last updated 2022-11-08
Summary
The purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.
Conditions
Interventions
- DRUG
-
Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection
608 will be administered subcutaneously.
- OTHER
-
Placebo
Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.
- DRUG
-
Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection
608 will be provided at pre-specified time intervals.
- OTHER
-
Placebo
Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Sponsors & Collaborators
-
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jinhua Xu, MD · Shanghai Huanshan Hospital Fudan University-Dermatology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-01
- Primary Completion
- 2023-05-31
- Completion
- 2023-08-31
Countries
- China
Study Locations
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