Condition: Inflammatory Bowel Diseases · Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
This phase will commence following dose escalation in the 24mg bid group during Phase I. Employing a 1:1:1 randomized, double-blind, placebo-controlled study design, it will evaluate the efficacy, safety, and Pharmacokinetics/Pharmacodynamics (PK/PD) characteristics of TQH3906 capsules in subjects with moderate-to-severe active ulcerative colitis. The study will include a maximum 4-week screening period, a 12-week treatment period, and a 4-week post-treatment follow-up period, enrolling a total of 105 subjects. Among these, subjects who failed conventional therapy and those who failed biologic therapy each constitute 35% of the cohort. week treatment period, and a 4-week post-treatment follow-up period. A total of 105 subjects will be enrolled, with 50% comprising subjects who failed conventional therapy and 50% comprising subjects who failed biologic therapy. Dose Group Design: Group A: Placebo Group B: 32mg dose group Group C: 24mg bid dose group The specific dose will be determined based on the 48mg dose group's medication experience from Phase I and adjusted as necessary.
This description comes directly from the study's public registry record.
Xiaowei Liu, Postdoctoral researcher · 13548762632 · liuxw@csu.edu.cn
Always discuss trial participation with your own doctor first.
| The First Affilliated Hospital of Bengbu Medical University | Bengbu, Anhui, China | Not Yet Recruiting |
| Gansu Wuwei Tumour Hospital | Wuwei, Gansu, China | Not Yet Recruiting |
| First affiliated hospital of guangzhou medical university | Guangzhou, Guangdong, China | Not Yet Recruiting |
| Zhujiang Hospital, of Southern Medical University | Guangzhou, Guangdong, China | Not Yet Recruiting |
| Huizhou First People's Hospital | Huizhou, Guangdong, China | Not Yet Recruiting |
| Heilongjiang provincial hospital | Harbin, Heilongjiang, China | Not Yet Recruiting |
| Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital) | Luoyang, Henan, China | Not Yet Recruiting |
| Luoyang First People's Hospital | Luoyang, Henan, China | Not Yet Recruiting |
| Nanyang Second General Hospital | Nanyang, Henan, China | Not Yet Recruiting |
| Henan Provincial People's Hospital | Zhengzhou, Henan, China | Not Yet Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou, Henan, China | Not Yet Recruiting |
| The Second Affiliated Hospital of Zhengzhou University | Zhengzhou, Henan, China | Not Yet Recruiting |
+ 18 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06754891