A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension Phase
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 29
- 主要终点
- Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57
研究概览
简要总结
This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, of any race, ≥18 and ≤60 years of age.
- •Have been diagnosed with active UC for ≥3 months prior to Day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation.
- •Have a total Mayo score ≥6, an endoscopic subscore ≥2, rectal bleeding subscore ≥1, and a stool frequency subscore ≥1, regardless of standard of care history.
- •Able to comprehend and willing to voluntarily sign an ICF and to abide by the study restrictions.
排除标准
- •Have received:
- •intravenous corticosteroids, rectally administered corticosteroids, or rectally administered 5-aminosalicylic acid within 3 weeks, or
- •Janus kinase (JAK) inhibitors within 2 weeks, or
- •cyclosporine, mycophenolate, tacrolimus, or methotrexate within 5 weeks, or
- •anti-TNF-α biologics within 9 weeks, or
- •any other biologics (including ustekinumab and vedolizumab) for the treatment of UC within 12 weeks.
- •Have received orally administered azathioprine or 6-mercaptopurine that has been stable for <8 weeks.
- •Have received orally administered 5-aminosalicylic acid, sulphasalazine, or low-dose corticosteroids (prednisolone ≤20 mg/day or equivalent) that have been stable for <5 weeks.
- •Have received any other concomitant medications for UC that have been stable (ie, have not started dosing with a new drug or had a change to their dosing regimen) for <7 days or 5 half-lives, whichever is longer.
- •Have Crohn's disease, indeterminate colitis, ischaemic colitis, fulminant colitis, toxic megacolon, chronic (as determined by the investigator) pancolitis, confined proctitis (distal, ≤15 cm), or symptomatic intestinal stenosis.
- •Have a history of extensive colonic resection (subtotal or total colectomy) or are anticipated to require surgical intervention for UC.
- •Have an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- •Have a positive test for Clostridium difficile, or have evidence of treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to Day 1.
研究组 & 干预措施
BBT-401-1S (800mg)
-
Induction Phase: BBT-401 800mg for 8 weeks
-
Extension Phase: After 8 weeks,
-
Participants who achieved clinical remission in the induction phase will continue the same treatment for 8 weeks
-
Participants who did not achieve clinical remission in the induction phase will receive BBT-401 1600mg for 8 weeks
干预措施: BBT-401-1S or Placebo (Drug)
BBT-401-1S (1,600mg)
- Induction Phase: BBT-401 1600mg for 8 weeks
- Extension Phase: After 8 weeks, Participants will continue the same treatment for 8 weeks
干预措施: BBT-401-1S or Placebo (Drug)
Placebo
-
Induction Phase: Placebo for 8 weeks
-
Extension Phase: After 8 weeks,
-
Participants who achieved clinical remission in the induction phase will continue the same treatment for 8 weeks
-
Participants who did not achieve clinical remission in the induction phase will receive BBT-401 800mg for 8 weeks
干预措施: BBT-401-1S or Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57
时间窗: Day 57
Clinical Response was defined as a Total Mayo Score, as measured by a reduction of ≥ 3 points and ≥ 30% improvement from baseline of Total Mayo Score, which included a decrease in rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore ≤ 1
次要结局
- Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score at Day 57(Day 57)
- Percentage of Participants Who Achieved an Endoscopic Remission at Day 57(Day 57)
- Change From Baseline to Day 57 in Total Mayo Score(Baseline, Day 57)