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

Completed · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The proposed study is a randomized, double-blind,placebo-controlled, multicenter phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active ulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 and time needed to induce clinical response in active ulcerative colitis patients. This is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded active arms 8-week extension phase. Early withdrawn subjects during the first treatment phase can not enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 18 weeks. SHR0302 is a Janus kinase 1(JAK1) inhibitor, capable of blocking Janus kinase-signal transducer and activator of transcription (JAK-STATs) pathway and controlling inflammation. Therefore it has the potential to be a treatment for ulcerative colitis.

Key facts

Study ID

NCT03675477

Run by

Reistone Biopharma Company Limited

People needed

164

Starts

2019-04-13

Expected to finish

2021-02-03

Last updated by the study team

2023-06-02

Who can join

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

You may qualify if…

• Male and Female subject age ≥ 18 and ≤75 years of age at randomization.
• Active ulcerative colitis with a 9-point modified Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (The duration of the time between endoscopy and baseline should not exceed 10 days and allow central over read turn over before randomization).
• Subject should have at least three-month history of Ulcerative Colitis diagnosis at randomization.

You may not qualify if…

• Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
• Subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or less).
• Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment).

Where it is running

• West Central Gastroenterology d/b/a Gastro Florida — Tampa, Florida, United States
• Digestive Disease Specialists, Inc. — Oklahoma City, Oklahoma, United States
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
• Henan Provincial People's Hospital — Zhengzhou, Henan, China
• Baotou Central Hospital — Baotou, Inner Mongalia, China
• Liaocheng People's Hospital — Liaocheng, Shandong, China
• Peking University Shougang Hospital — Beijing, China
• Peking University Third Hospital — Beijing, China
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, China
• The First Hospital of Jillin University — Changchun, China
• Xiangya Hospital Central South University — Changsha, China
• West China Hospital Sichuan University — Chengdu, China
• Fujian Provincial Hospital — Fuzhou, China
• The Sixth Affiliated Hospital of Sun Yat- Sen University — Guangzhou, China
• Sir Run Run Shaw Hospital — Hangzhou, China
• Huaian First People's Hospital — Huai'an, China
• Huzhou Central Hospital — Huzhou, China
• Qilu Hospital of Shandong University — Jinan, China
• The First People's Hospital of Lianyungang — Lianyungang, China
• Jiangsu Province Hospital — Nanjing, China
• Nanjing First Hospital — Nanjing, China
• Nanjing Drum Tower Hospital — Nanjing, China
• Zhongda Hospital Southeast University — Nanjing, China
• Wellness Clinical Research, LLLC-Central Florida — Lake Wales, Florida, United States

Full record on ClinicalTrials.gov

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