A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease
NCT ID: NCT03677648
Last Updated: 2023-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2019-05-14
2021-12-09
Brief Summary
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With the wealth of scientific evidence on JAK/STAT involvement in IBD, the data from similar class of new drugs and the current data on SHR0302 (JAK1 inhibitor), support the rationale to proceed with phase II studies to evaluate the efficacy and safety of SHR0302 in patients with moderate to severe active CD.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SHR0302 dose A
Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 24.
SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
SHR0302 dose B
Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 24.
SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
SHR0302 dose C
Participants randomized in this arm will receive dose C of SHR0302 until end of study at week 24.
SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
Placebo
Participants randomized in this arm will receive placebo until week 12, and then will be re-randomized into one of the 3 active arms (dose A, dose B, and dose C of SHR0302) in a 1:1:1 allocation ratio until the end of study at week 24.
SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
Placebos
Placebos
Interventions
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SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
Placebos
Placebos
Eligibility Criteria
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Inclusion Criteria
* Subjects with a documented three-month history of diagnosed ileal, colonic, or ileocolonic Crohn's Disease at the time of randomization.
* Currently having Crohn's Disease with Crohn's Disease Activity Index (CDAI) score ≥ 220 to ≤450.
Exclusion Criteria
* Subject with CD with stoma, gastric or ileoanal pouch, proto-colectomy or total colectomy, symptomatic stenosis or stricture, history of bowel perforation, suspected abscess; actively draining fistula.
* Treatment naïve subjects diagnosed with Crohn's disease, (without previous exposure to treatment).
18 Years
75 Years
ALL
No
Sponsors
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Reistone Biopharma Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Xiang Chen
Role: STUDY_DIRECTOR
Reistone Biopharma
Locations
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West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, United States
Wellness Clinical Research, LLLC-Central Florida
Lake Wales, Florida, United States
West Central Gastroenterology d/b/a Gastro Florida
Tampa, Florida, United States
NECCR Primacare Research, LLC
Fall River, Massachusetts, United States
Wilmington Health
Wilmington, North Carolina, United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, United States
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Yijishan Hospital of Wannan Medical College
Yingshan, Anhul, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanchang University
Guangzhou, Guangzhou, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangzhou, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital Affiliated to Tongji Medicine College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Henan Provincial People's Hospital
Pingxiang, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Yangzhou First People's Hospital
Yangzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The first Hospital of Jilin University
Changchun, Jilin, China
Ruijin Hospital, Shanghai Jiaotong University, School of Medicne
Shanghai, Shanghai Municipality, China
Shanghai Xinhua Hospital
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Tianjin Union Medical Center
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital, Affiliated with the Zhejiang University School of Medicine
Hangzhou, Zheijiang, China
Huzhou Central Hospital
Huzhou, Zheijiang, China
Nanfang Hospital of Southern Medical University
Changchun, , China
Xiangya Hospital Central South University
Changsha, , China
st China Hospital Sichuan University
Chengdu, , China
Fujian Provincial Hospital
Fuzhou, , China
Qilu Hospital of Shandong University
Jinan, , China
Jiangsu Province Hospital
Nanjing, , China
Nanjing First Hospital
Nanjing, , China
The Affiliated Hospital of Nanjing University School
Nanjing, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, , China
Shanxi Provincial People's Hospital
Taiyuan, , China
Second hospital of Shanxi Medical university
Taiyuan, , China
Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurów, , Poland
Amicare Sp. z o.o. Sp.k
Lodz, , Poland
SALVE Zakład Opieki Zdrowotnej Sp. zo.o.
Lodz, , Poland
Nzoz Allmedica Badania
Nowy Targ, , Poland
Provita Profamilia
Piotrkow Trybunalski, , Poland
SOLUMED Centrum Medyczne
Poznan, , Poland
KO-MED Central Kliniczne Plulawy
Puławy, , Poland
Gabinet Lekarski Bartosz Korczowski
Rzeszów, , Poland
Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
Sopot, , Poland
KO-MED Centra Kliniczne Staszow
Staszów, , Poland
EZ-MED Centrum Medyczne
Swidnica, , Poland
Centrum Zdrowia MDM
Warsaw, , Poland
Centralny Szpital Kliniczny MSW
Warsaw, , Poland
Nzoz Vivamed
Warsaw, , Poland
PlanetMed sp. z o.o.
Wroclaw, , Poland
RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
Chernivtsi, , Ukraine
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
Dnipro, , Ukraine
I.I.Mechnykov Dnipropetrovsk
Dnipro, , Ukraine
Ivano-Frankivsk Hospital
Ivano-Frankivsk, , Ukraine
Ivano-Frankivsk Med. University
Ivano-Frankivsk, , Ukraine
CHI Kharkiv City Clinical Hospital #13
Kharkiv, , Ukraine
Public nonprofit enterprise
Kharkiv, , Ukraine
Kherson City Clinical Hospital
Kherson, , Ukraine
Khmelnyski Regional Hospital
Khmelnytskyi, , Ukraine
Tx-Dx Center Adonis Plus Ltd
Kiev, , Ukraine
Healthy and Happy
Kyiv, , Ukraine
Kyiv City Clinical Hospital
Kyiv, , Ukraine
Kyiv Clin Hospital on Railway St. 2
Kyiv, , Ukraine
Med. Cen.of Limited Liability
Kyiv, , Ukraine
Kyiv Regional Hospital #2
Kyiv, , Ukraine
Lviv Regional Clinical Hosp
Lviv, , Ukraine
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
Lviv, , Ukraine
Medical Center Pulse
Vinnytsia, , Ukraine
RCH Vinnytsia, Dept. Therapy
Vinnytsia, , Ukraine
Vinnytsia M I Pyrogov
Vinnytsia, , Ukraine
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia, , Ukraine
Communal Institution Center of the Primary Medical- Sanitary Care#2
Vinnytsia, , Ukraine
Center of primary health care
Vinnytsia, , Ukraine
City Clinical Hospital
Zaporizhzhya, , Ukraine
O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital
Zhytomyr, , Ukraine
Countries
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Other Identifiers
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RSJ10201
Identifier Type: -
Identifier Source: org_study_id
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