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Shr0302    (DrugBank: -)

4 diseases
告示番号疾患名（ページ内リンク）臨床試験数
46悪性関節リウマチ5
96クローン病2
97潰瘍性大腸炎2
271強直性脊椎炎1

46. 悪性関節リウマチ　［臨床試験数：4,183，薬物数：2,538（DrugBank：401），標的遺伝子数：183，標的パスウェイ数：219］
Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
5 / 4,183 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT04333771
(ClinicalTrials.gov)		July 31, 20202/4/2020A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid ArthritisA Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs.Rheumatoid ArthritisDrug: SHR0302;Drug: PlaceboJiangsu HengRui Medicine Co., Ltd.NULLRecruiting18 Years75 YearsAll600Phase 3China
2NCT03254966
(ClinicalTrials.gov)		September 201715/8/2017Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) PatientsRandomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisDrug: SHR0302;Drug: PlaceboJiangsu HengRui Medicine Co., Ltd.NULLNot yet recruiting18 Years70 YearsAll170Phase 2China
3NCT02892370
(ClinicalTrials.gov)		August 20162/9/2016Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy SubjectsAn Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy VolunteersRheumatoid ArthritisDrug: SHR0302Jiangsu HengRui Medicine Co., Ltd.NULLRecruiting18 Years45 YearsMale14Phase 1China
4NCT02665910
(ClinicalTrials.gov)		May 201624/1/2016Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) PatientsA Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RARheumatoid ArthritisDrug: SHR0302;Drug: SHR0302 placebo comparatorJiangsu HengRui Medicine Co., Ltd.NULLNot yet recruiting18 Years70 YearsBoth48Phase 1China
5NCT02423538
(ClinicalTrials.gov)		April 20157/4/2015First-in-Human Single Ascending Dose of SHR0302A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy VolunteersRheumatoid ArthritisDrug: SHR0302;Drug: SHR0302 placebo comparatorJiangsu HengRui Medicine Co., Ltd.NULLActive, not recruiting18 Years45 YearsBoth64Phase 1China

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96. クローン病　［臨床試験数：2,209，薬物数：1,276（DrugBank：240），標的遺伝子数：166，標的パスウェイ数：210］
Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 2,209 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT03677648
(ClinicalTrials.gov)		May 14, 201917/9/2018A Phase II Study in Patients With Moderate to Severe Active Crohn's DiseaseA Phase II Randomized, Placebo Controlled, Double-blind, Four Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Crohn's DiseaseCrohn's DiseaseDrug: SHR0302;Drug: PlacebosReistone Biopharma Company LimitedNULLRecruiting18 Years75 YearsAll144Phase 2United States;China;Poland;Ukraine
2EUCTR2018-003303-19-PL
(EUCTR)		15/03/201923/01/2019A Phase II Study in Patients With Moderate to Severe Active Crohn’s Disease.A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Crohn’s Disease. Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Reistone Biopharma Company LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		144Phase 2United States;Poland;Ukraine;China

97. 潰瘍性大腸炎　［臨床試験数：2,269，薬物数：1,331（DrugBank：241），標的遺伝子数：114，標的パスウェイ数：181］
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 2,269 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT03675477
(ClinicalTrials.gov)		April 13, 201916/9/2018A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.A Phase II Randomized, Placebo Controlled, Double-blind, 4 Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Ulcerative Colitis.Ulcerative ColitisDrug: SHR0302;Drug: PlacebosReistone Biopharma Company LimitedNULLActive, not recruiting18 Years75 YearsAll164Phase 2United States;China;Poland;Puerto Rico;Ukraine
2EUCTR2018-003364-31-PL
(EUCTR)		15/03/201923/01/2019A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Ulcerative Colitis. Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Product Code: SHR0302
INN or Proposed INN: Pending		Reistone Biopharma Company LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		152Phase 2United States;Poland;Ukraine;China

271. 強直性脊椎炎　［臨床試験数：531，薬物数：343（DrugBank：66），標的遺伝子数：41，標的パスウェイ数：141］
Searched query = "Ankylosing spondylitis", "Spondylarthritis ankylopoietica"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 531 trial found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT04481139
(ClinicalTrials.gov)		October 21, 202015/7/2020A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Adaptive Seamless Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Ankylosing Spondylitis SubjectsAnkylosing SpondylitisDrug: SHR0302;Drug: SHR0302 placeboJiangsu HengRui Medicine Co., Ltd.NULLRecruiting18 Years75 YearsAll480Phase 2;Phase 3China

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