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

Completed · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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 Early withdrawn subjects during the first treatment phase cannot enter the extension phase.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.

Key facts

Study ID

NCT03677648

Run by

Reistone Biopharma Company Limited

People needed

112

Starts

2019-05-14

Expected to finish

2021-12-09

Last updated by the study team

2023-03-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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
• West Central Gastroenterology d/b/a Gastro Florida — Clearwater, Florida, United States

Full record on ClinicalTrials.gov

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