SHR0302

DRUG17 trials

Sponsors

Jiangsu HengRui Medicine Co., Ltd., Reistone Biopharma Company Limited, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Henan Cancer Hospital

Conditions

Alopecia AreataAnkylosing SpondylitisChronic GVHDCrohn's DiseaseGraft-versus-host DiseaseHealthy SubjectsHepatic ImpairmentNon-radiographic Axial Spondyloarthritis

Early Phase 1

SHR0302 and Steroid As First Line Therapy for Chronic GVHD

CompletedNCT04146207

Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineChronic GVHD

Start: 2020-04-02End: 2024-10-31Updated: 2024-11-13

Phase 1

First-in-Human Single Ascending Dose of SHR0302

Jiangsu HengRui Medicine Co., Ltd.Rheumatoid Arthritis

Start: 2015-04-30Updated: 2016-01-26

Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients

Jiangsu HengRui Medicine Co., Ltd.Rheumatoid Arthritis

Start: 2016-05-31Target: 48Updated: 2016-04-19

Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects

Jiangsu HengRui Medicine Co., Ltd.Rheumatoid Arthritis

Start: 2016-08-31End: 2016-10-31Target: 14Updated: 2016-09-08

Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

CompletedNCT04293029

Jiangsu HengRui Medicine Co., Ltd.Hepatic Impairment

Start: 2020-05-20End: 2020-12-30Updated: 2021-10-14

Study on the Bioavailability of SHR0302 in Healthy Subjects

CompletedNCT04712838

Jiangsu HengRui Medicine Co., Ltd.Healthy Subjects

Start: 2021-03-15End: 2021-04-13Updated: 2021-10-20

To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability

CompletedNCT05856058

Jiangsu HengRui Medicine Co., Ltd.Graft-versus-host Disease

Start: 2023-05-29End: 2023-10-09Updated: 2023-12-08

Efficacy and Safety of SHR0302 in Patients With Relapsed/Refractory Peripheral T/NK Cell Lymphoma

Not yet recruitingNCT05900089

Henan Cancer HospitalPeripheral T Cell Lymphoma

Start: 2023-05-30End: 2026-06-01Target: 30Updated: 2023-06-12

Phase 2

Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients

CompletedNCT03254966

Jiangsu HengRui Medicine Co., Ltd.Rheumatoid Arthritis

Start: 2017-11-24End: 2019-10-12Updated: 2021-09-30

A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

CompletedNCT03675477

Reistone Biopharma Company LimitedUlcerative Colitis

Start: 2019-04-13End: 2021-02-03Updated: 2023-06-02

A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease

CompletedNCT03677648

Reistone Biopharma Company LimitedCrohn's Disease

Start: 2019-05-14End: 2021-12-09Updated: 2023-03-15

A Phase II Study in Patients With Alopecia Areata

CompletedNCT04346316

Reistone Biopharma Company LimitedAlopecia Areata

Start: 2020-05-13End: 2021-06-29Updated: 2021-07-16

A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis

CompletedNCT04481139

Jiangsu HengRui Medicine Co., Ltd.Ankylosing Spondylitis

Start: 2020-10-14End: 2023-05-12Updated: 2023-07-27

Phase 3

A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis

CompletedNCT04333771

Jiangsu HengRui Medicine Co., Ltd.Rheumatoid Arthritis

Start: 2020-07-31End: 2023-09-21Updated: 2023-11-22

A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis

Reistone Biopharma Company LimitedUlcerative Colitis

Start: 2021-11-05End: 2025-03-31Target: 368Updated: 2023-09-05

A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Non-Radiographic Axial Spondyloarthritis

Jiangsu HengRui Medicine Co., Ltd.Non-radiographic Axial Spondyloarthritis

Start: 2022-08-16End: 2024-12-11Target: 300Updated: 2022-09-02

Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Severe Alopecia Areata

Reistone Biopharma Company LimitedAlopecia Areata

Start: 2022-04-18End: 2024-02-15Updated: 2023-09-05

Related Papers

Ivarmacitinib in patients with active ankylosing spondylitis: subgroup analysis based on key baseline features from a phase II/III trial.

2026-07-28

Pharmacokinetics and safety of SHR0302, a selective JAK1 inhibitor, in Chinese patients with hepatic impairment

Frontiers in Pharmacology2026-07-02

Effect of ivarmacitinib on patient-reported outcomes in patients with moderate-to-severe active rheumatoid arthritis: a post-hoc analysis of a phase III trial.

2026-04-01

Effect of ivarmacitinib on swelling and tenderness in small and large joints and imaging changes in patients with moderate-to-severe RA: a post hoc analysis of a phase III clinical trial.

2026-02-26

Ivarmacitinib reduces the need for adding/escalating medications in moderate-to-severe rheumatoid arthritis patients: a <i>post hoc</i> analysis from a phase III trial.

2025-11-21

Ivarmacitinib improves patient-reported outcomes across multiple domains in patients with active ankylosing spondylitis: a <i>post hoc</i> analysis of a phase II/III trial.

2025-11-20

Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial.

2025-01-035 citations

Efficacy and Safety of Ivarmacitinib in Patients With Moderate-to-Severe, Active, Ulcerative Colitis: A Phase II Study.

2022-08-1030 citations

Efficacy and Safety of SHR0302, a Highly Selective Janus Kinase 1 Inhibitor, in Patients with Moderate to Severe Atopic Dermatitis: A Phase II Randomized Clinical Trial.

2021-08-0938 citations