A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157
详细描述
This is a multi-center, long-term safety study to evaluate the safety and tolerability of TD-1473 for up to 156 weeks (3 years) + 4 week follow-up in subjects with moderate to severe UC exiting the preceding Maintenance Study of Protocol 0157 (NCT03758443).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for the study, subjects are required to enter the LTS Study within 14 days of exiting the Maintenance Study of Protocol 0157 and must meet all the following criteria:
- •Capable of providing informed consent, which must be obtained prior to any study related procedures.
- •One of the following:
- •Those who demonstrated persistent loss of response (no improvement 8 weeks after meeting loss of response criteria) OR
- •Two Clinical Flares after an episode of loss of response during the Maintenance Study OR
- •Those who have completed the Maintenance Study and confirmation of clinical remission status results are available
- •During the study and for 7 days after receiving the last dose of the study drug, females of childbearing potential or men capable of fathering children must agree to use highly effective birth control measures (failure rate <1% when used consistently and correctly)) or agree to abstain from sexual intercourse. Females of childbearing potential must test negative for pregnancy at Day 1
- •All male subjects must agree to refrain from semen donation during the study and for 7 days after the last dose of study drug.
- •Must be able and willing to adhere to the study visit schedule and comply with other study requirements.
排除标准
- •Has symptoms suggestive of fulminant colitis, megacolon or intestinal perforation
- •Likely to require surgery for UC or other major surgeries
- •Has previously received / is currently receiving prohibited medications
- •Has been diagnosed during Protocol 0157 with Crohn's disease, other colitis conditions or the subject has a current or past diagnosis of a fistula or abdominal abscess
- •Has endoscopic findings during Protocol 0157 of colitis-associated colonic dysplasia (with the exception of subjects with non-colitis associated spontaneous adenomas that have been completely resected)
- •Has clinically significant abnormalities in laboratory evaluations
- •Additional exclusion criteria apply
研究组 & 干预措施
Active Treatment TD-1473 with Dose A
Oral daily dose of TD-1473 for up to 156 weeks
干预措施: TD-1473 Dose A (Drug)
Active Treatment TD-1473 with Dose B
Oral daily dose of TD-1473 for up to 156 weeks
干预措施: TD-1473 Dose B (Drug)
Active Treatment TD-1473 with Dose C
Oral daily dose of TD-1473 for up to 156 weeks
干预措施: TD-1473 Dose C (Drug)
结局指标
主要结局
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
时间窗: Day 1 up to 4 weeks after last dose of study drug (median treatment duration was: TD-1473 20 mg - 142 days; TD-1473 80 mg - 180.0 days; TD-1473 200 mg - 158 days)
A TEAE was defined as any AE with a recorded start date on or after the date of the first dose of study drug up through 4 weeks after the last dose of study drug. Any clinically significant changes in laboratory safety tests, electrocardiograms (ECGs) and vital signs, were also recorded as TEAEs.
次要结局
未报告次要终点