A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease
- Registration Number
- NCT03677648
- Lead Sponsor
- Reistone Biopharma Company Limited
- Brief Summary
The proposed study is a randomized, double-blind, placebo-controlled, multi-center Phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active Crohn's Disease. The study aims to evaluate the optimal dose of SHR0302 and time needed in inducing clinical remission in active CD. This is an 12+12 weeks study, in which participants who complete the first 12 weeks treatment phase, will have the option to enter a blinded active arms 12-week extension phase. Early withdrawn subjects during the first treatment phase cannot enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 26 weeks.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- Male and Female subject at ≥18 and ≤ 75 years of age at randomization.
- 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.
- Diagnosis of indeterminate colitis, or clinical findings suggestive of Ulcerative Colitis.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHR0302 dose B SHR0302 Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 24. SHR0302 dose C SHR0302 Participants randomized in this arm will receive dose C of SHR0302 until end of study at week 24. Placebo Placebos 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 dose A SHR0302 Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 24. Placebo SHR0302 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.
- Primary Outcome Measures
Name Time Method The percentage of subjects achieving clinical remission at week 12. week12 The percentage of subjects achieving clinical remission at week 12, defined as Crohn's Disease Activity Index (CDAI) score \< 150.
- Secondary Outcome Measures
Name Time Method The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24. week 1, 4, 8, 12, 13, 16, and 24 The percentage of subjects achieving clinical response defined as a CDAI decrease from baseline of ≥ 100 points at week 1, 4, 8, 12, 13, 16, and 24.
The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24. week 1, 4, 8, 12, 13, 16, and 24 The percentage of subjects achieving clinical remission defined as mean daily stool frequency (SF) ≤2.5, and abdominal pain (AP) ≤ 1 using the Patient Reported Outcome from CDAI at week 1, 4, 8, 12, 13, 16, and 24.
The percentage of subjects achieving clinical remission defined as PRO2 < 8 at week 1, 4, 8, 12, 13, 16, and 24. week 1, 4, 8, 12, 13, 16, and 24 The percentage of subjects achieving clinical remission defined as PRO2 \< 8 at week 1, 4, 8, 12, 13, 16, and 24.
Trial Locations
- Locations (79)
Gabinet Lekarski Bartosz Korczowski
🇵🇱Rzeszów, Poland
SALVE Zakład Opieki Zdrowotnej Sp. zo.o.
🇵🇱Łódź, Poland
I.I.Mechnykov Dnipropetrovsk
🇺🇦Dnipro, Ukraine
Ivano-Frankivsk Med. University
🇺🇦Ivano-Frankivs'k, Ukraine
Khmelnyski Regional Hospital
🇺🇦Khmelnytskyi, Ukraine
Healthy and Happy
🇺🇦Kyiv, Ukraine
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
🇺🇦Lviv, 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
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
🇨🇳Nanchang, Jiangxi, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Tongji Hospital Affiliated to Tongji Medicine College, Huazhong University of Science & Technology
🇨🇳Wuhan, Hubei, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
The first Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Ruijin Hospital, Shanghai Jiaotong University, School of Medicne
🇨🇳Shanghai, Shanghai, China
Shanghai Xinhua Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
Sir Run Run Shaw Hospital, Affiliated with the Zhejiang University School of Medicine
🇨🇳Hangzhou, Zheijiang, China
Huzhou Central Hospital
🇨🇳Huzhou, Zheijiang, China
Xiangya Hospital Central South University
🇨🇳Changsha, China
Fujian Provincial Hospital
🇨🇳Fuzhou, China
Qilu Hospital of Shandong University
🇨🇳Jinan, China
Second hospital of Shanxi Medical university
🇨🇳Taiyuan, China
Wellness Clinical Research, LLLC-Central Florida
🇺🇸Lake Wales, Florida, United States
The Sixth Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangzhou, China
NECCR Primacare Research, LLC
🇺🇸Fall River, Massachusetts, United States
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
SOLUMED Centrum Medyczne
🇵🇱Poznań, Poland
EZ-MED Centrum Medyczne
🇵🇱Świdnica, Poland
Henan Provincial People's Hospital
🇨🇳Pingxiang, Hunan, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
The University of Hong Kong-Shenzhen Hospital
🇨🇳Shenzhen, China
Nzoz Allmedica Badania
🇵🇱Nowy Targ, Poland
Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
🇵🇱Sopot, Poland
Nzoz Vivamed
🇵🇱Warszawa, Poland
Yangzhou First People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Shanxi Provincial People's Hospital
🇨🇳Taiyuan, China
Provita Profamilia
🇵🇱Piotrków Trybunalski, Poland
KO-MED Centra Kliniczne Staszow
🇵🇱Staszów, Poland
Tianjin Union Medical Center
🇨🇳Tianjin, Tianjin, China
Nanfang Hospital of Southern Medical University
🇨🇳Changchun, China
Centralny Szpital Kliniczny MSW
🇵🇱Warszawa, Poland
Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla
🇵🇱Knurów, Poland
RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
🇺🇦Chernivtsi, Ukraine
West Central Gastroenterology d/b/a Gastro Florida
🇺🇸Tampa, Florida, United States
Digestive Disease Specialists, Inc.
🇺🇸Oklahoma City, Oklahoma, United States
Wilmington Health
🇺🇸Wilmington, North Carolina, United States
Yijishan Hospital of Wannan Medical College
🇨🇳Yingshan, Anhul, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
st China Hospital Sichuan University
🇨🇳Chengdu, China
Kherson City Clinical Hospital
🇺🇦Kherson, Ukraine
Public nonprofit enterprise
🇺🇦Kharkiv, Ukraine
Kyiv Regional Hospital #2
🇺🇦Kyiv, Ukraine
Tx-Dx Center Adonis Plus Ltd
🇺🇦Kiev, Ukraine
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
🇺🇦Dnipro, Ukraine
Ivano-Frankivsk Hospital
🇺🇦Ivano-Frankivs'k, Ukraine
KO-MED Central Kliniczne Plulawy
🇵🇱Puławy, Poland
Kyiv City Clinical Hospital
🇺🇦Kyiv, Ukraine
Kyiv Clin Hospital on Railway St. 2
🇺🇦Kyiv, Ukraine
Medical Center Pulse
🇺🇦Vinnytsia, Ukraine
City Clinical Hospital
🇺🇦Zaporizhzhya, Ukraine
Centrum Zdrowia MDM
🇵🇱Warszawa, Poland
PlanetMed sp. z o.o.
🇵🇱Wrocław, Poland
CHI Kharkiv City Clinical Hospital #13
🇺🇦Kharkiv, Ukraine
Med. Cen.of Limited Liability
🇺🇦Kyiv, Ukraine
O.F. Herbachevskiyi Zhytomyr Regional Clinical Hospital
🇺🇦Zhytomyr, Ukraine
Amicare Sp. z o.o. Sp.k
🇵🇱Łódź, Poland
Lviv Regional Clinical Hosp
🇺🇦Lviv, Ukraine
Communal Institution Center of the Primary Medical- Sanitary Care#2
🇺🇦Vinnytsia, Ukraine
Center of primary health care
🇺🇦Vinnytsia, Ukraine
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
Shanghai Changhai Hospital
🇨🇳Shanghai, Shanghai, China
The Affiliated Hospital of Nanjing University School
🇨🇳Nanjing, China
Nanjing First Hospital
🇨🇳Nanjing, China
Jiangsu Province Hospital
🇨🇳Nanjing, China