Ivarmacitinib

Generic Name: Ivarmacitinib

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₂N_₈O_₂S

CAS Number: 1445987-21-2

Unique Ingredient Identifier: K6K4B9Z5TV

Background: Ivarmacitinib (SHR0302) is a selective inhibitor of Janus kinase 1 (JAK1) under investigation for the treatment of various immuno-inflammatory conditions. While ivarmactinib has yet to receive marketing authorization, as of February 2022 clinical trials are ongoing or completed evaluating its use in atopic dermatitis, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, graft-versus-host disease, vitiligo, ulcerative colitis, alopecia areata, and primary membranous nephropathy.

Clinical Trials

A Phase II Study in Patients With Alopecia Areata

Phase 2

Completed

Conditions: Alopecia Areata

Interventions: Drug: SHR0302

First Posted Date: 2020-04-15

Last Posted Date: 2021-07-16

Lead Sponsor: Reistone Biopharma Company Limited

Target Recruit Count: 94

Registration Number: NCT04346316

Locations: 🇨🇳
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China
🇨🇳
The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
🇨🇳
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

and more 26 locations

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

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Placebo
Drug: SHR0302

First Posted Date: 2020-04-03

Last Posted Date: 2023-11-22

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 566

Registration Number: NCT04333771

Locations: 🇨🇳
Liuzhou workers' Hospital, Liuzhou, Guangxi, China

Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

Phase 1

Completed

Conditions: Hepatic Impairment

Interventions: Drug: SHR0302

First Posted Date: 2020-03-03

Last Posted Date: 2021-10-14

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 24

Registration Number: NCT04293029

Locations: 🇨🇳
The First Affiliated Hospital of Jilin University, Changchun, Jilin, China

SHR0302 and Steroid As First Line Therapy for Chronic GVHD

Early Phase 1

Completed

Conditions: Chronic GVHD

Interventions: Drug: SHR0302
Drug: Prednisone

First Posted Date: 2019-10-31

Last Posted Date: 2024-11-13

Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Target Recruit Count: 28

Registration Number: NCT04146207

Locations: 🇨🇳
Shanghai General Hospital, Shanghai, Shanghai, China
🇨🇳
Xianmin Song, Shanghai, Shanghai, China

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

Phase 2

Completed

Conditions: Crohn's Disease

Interventions: Drug: SHR0302
Drug: Placebos

First Posted Date: 2018-09-19

Last Posted Date: 2023-03-15

Lead Sponsor: Reistone Biopharma Company Limited

Target Recruit Count: 112

Registration Number: NCT03677648

Locations: 🇵🇱
Gabinet Lekarski Bartosz Korczowski, Rzeszów, Poland
🇵🇱
SALVE Zakład Opieki Zdrowotnej Sp. zo.o., Łódź, Poland
🇺🇦
I.I.Mechnykov Dnipropetrovsk, Dnipro, Ukraine

and more 76 locations

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

Phase 2

Completed

Conditions: Ulcerative Colitis

Interventions: Drug: SHR0302
Drug: Placebo

First Posted Date: 2018-09-18

Last Posted Date: 2023-06-02

Lead Sponsor: Reistone Biopharma Company Limited

Target Recruit Count: 164

Registration Number: NCT03675477

Locations: 🇺🇸
Wellness Clinical Research, LLLC-Central Florida, Lake Wales, Florida, United States
🇺🇦
Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU, Ivano-Frankivs'k, Ukraine
🇵🇱
Nzoz Formed, Wadowice, Poland

and more 63 locations