NCT03800420终止2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 11
- 主要终点
- Change From Baseline in Total Mayo Score
研究概览
简要总结
This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis.
This study consists of three cohorts with 16-week treatment period per cohort that will be conducted sequentially.
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
- 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
- •Provision of signed and dated informed consent form (ICF)
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged >=18 years
- •Diagnosed with active UC for at least 3 months prior to screening
- •Total Mayo score >=5 and Endoscopic sub-score >=1
- •Stable dosing regimens of oral drugs (if currently administered) as follows: 5-ASA or sulfasalazine at a stable dose for at least 4 weeks, purine analogues (azathioprine, mercaptopurine, thiopurines) or methotrexate at a stable dose for at least 12 weeks, and low-dose oral corticosteroid (up to 20 mg prednisone/day or equivalent) for at least 4 weeks prior to the first dose of study treatment. Doses of oral drugs must remain stable until the end of study treatment (with possible exception for tapering steroid dose after 8 weeks)
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the last dose
- •For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 3 months after the last dose
排除标准
- •Use of anti-TNF-a biologics or any other biologics for treatment of UC within 60 days prior to randomization.
- •Any rectal therapy for treatment of UC or intravenous corticosteroids within 2 weeks prior to randomization.
- •Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
- •Previous extensive colonic resection (subtotal or total colectomy)
- •Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- •Evidence of or treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to randomization
- •Active infection with the HIV or Hepatitis B or C viruses
- •Clinically significant active extra-intestinal infection (e.g., pneumonia, pyelonephritis)
- •Clinically significant abnormal vital signs, physical examination or 12-lead electrocardiogram (ECG) at screening or baseline
- •Clinically significant abnormal results of liver function tests (ALT/AST, bilirubin and alkaline phosphatase) > 2X the upper limit of normal (ULN) at screening
- •Other clinically significant abnormal laboratory results at screening in the investigator's opinion
- •History of any clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study
- •Pregnancy or lactation
- •Treatment with another investigational drug or other intervention within 30 days prior to screening
研究组 & 干预措施
BBT-401-1S
Experimental
BBT-401-1S, Oral capsule, QD
干预措施: BBT-401-1S first and then Placebo (Drug)
Placebo
Placebo Comparator
Placebo, Oral capsule, QD
干预措施: Placebo first and then BBT-401-1S (Drug)
结局指标
主要结局
Change From Baseline in Total Mayo Score
时间窗: Week 8
The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points. The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.
次要结局
- Change From Baseline in Partial Mayo Score(Week 8)
- Change From Baseline in Histologic Assessment of Endoscopic Biopsy(Week 8)
- Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)(Week 8)
- Number and Severity of TEAEs(up to 8 weeks after the last dose)
- Plasma Concentration of BBT- 401-1S(Day 1, Week 4, Week 8)
- Change From Baseline in Concentration of Serum CRP(Week 8)
- Change From Baseline in Concentration of Fecal Calprotectin(Week 8)
- Change From Baseline in Concentration of Fecal Lactoferrin(Week 8)
研究者
研究点 (11)
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