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SHR-1314

DRUG12 trials

Sponsors

Atridia Pty Ltd., Jiangsu HengRui Medicine Co., Ltd., Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Conditions

Active Moderate to Severe Graves' OrbitopathyAnkylosing SpondylitisAxial SpondyloarthritisBioequivalenceChildren and Adolescents Aged 6 to 18 With Moderate-to-Severe Plaque PsoriasisLupus NephritisModerate-to-Severe Plaque PsoriasisModerate-to-severe Chronic Plaque Psoriasis

Phase 1

A Study of SHR-1314 in Healthy Subjects
CompletedNCT02934412
Atridia Pty Ltd.Psoriasis
Start: 2016-08-22End: 2017-06-30Updated: 2017-11-14
Multi-Dose Study of SHR-1314 in Subjects With Moderate-to-severe Plaque Psoriasis
CompletedNCT03463187
Jiangsu HengRui Medicine Co., Ltd.Moderate-to-severe Chronic Plaque Psoriasis
Start: 2017-12-15End: 2020-08-31Updated: 2023-08-08
Safety, Tolerability and PK of SHR1314 in axSpA
CompletedNCT03704428
Jiangsu HengRui Medicine Co., Ltd.Axial Spondyloarthritis
Start: 2018-04-19End: 2020-01-14Updated: 2021-01-13
A Safety Study of Multiple Subcutaneous (s.c.) Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis
NCT03710681
Jiangsu HengRui Medicine Co., Ltd.Moderate-to-severe Plaque Psoriasis
Start: 2018-08-02End: 2019-07-30Target: 16Updated: 2018-10-18
A Study to Compare Pharmacokinetic and Safety Profiles of Different Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects
NCT04326881
Jiangsu HengRui Medicine Co., Ltd.Pharmacokinetic
Start: 2020-04-07End: 2020-11-30Target: 30Updated: 2020-03-30
A Bioequivalence Study to Compare Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects
NCT04527484
Jiangsu HengRui Medicine Co., Ltd.Bioequivalence
Start: 2020-08-20End: 2021-03-30Target: 130Updated: 2020-08-26
A Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications Devices
CompletedNCT06182384
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Moderate-to-Severe Plaque Psoriasis
Start: 2023-12-24End: 2024-05-13Updated: 2024-06-14

Phase 2

Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis
CompletedNCT04840485
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Ankylosing Spondylitis
Start: 2021-06-09End: 2024-02-28Updated: 2024-05-22
A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis
NCT04924296
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Lupus Nephritis
Start: 2021-06-28End: 2022-09-03Target: 60Updated: 2021-06-11
Efficacy and Safety of SHR-1314 by Subcutaneous Injection in Active Moderate to Severe Graves' Orbitopathy Patients
TerminatedNCT05394857
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Active Moderate to Severe Graves' Orbitopathy
Start: 2022-09-13End: 2023-08-22Updated: 2024-12-27

Phase 3

Efficacy 、Safety and PK of SHR-1314 in Patients With Moderate-to-Severe Plaque Psoriasis
NCT04839016
Jiangsu HengRui Medicine Co., Ltd.Moderate-to-Severe Plaque Psoriasis
Start: 2021-04-25End: 2023-08-30Target: 660Updated: 2021-04-09
The Efficacy and Safety of SHR-1314 in the Treatment of Pediatric Patients of Age 6 to <18 Years With Moderate to Severe Plaque Psoriasis
Not yet recruitingNCT06833307
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Children and Adolescents Aged 6 to 18 With Moderate-to-Severe Plaque Psoriasis
Start: 2025-02-28End: 2026-08-31Target: 90Updated: 2025-02-18

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