A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy Signal of TP-317 in Patients With Active Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Safety of TP317
研究概览
简要总结
Purpose of study is to evaluate the safety, tolerability, pharmacokinetics of TP317 vs. placebo in adults with active ulcerative colitis. Participants will be randomly assigned to receive either daily oral tablets (8 tablets) of TP317 (80 mg) or an identical placebo pill. Study will include 2 colonoscopies, daily dosing (including at home and in clinic), safety assessments, diary and questionnaire completion and 5 in clinic visits.
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)
盲法说明
Sponsor, Clinical Research Organization
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of UC with disease duration of at least 12 weeks prior to randomization
- •Evidence of active UC at Screening, defined by all of the following:
- •MMS of 5 to 8, inclusive;
- •RBS of ≥ 1; and
- •Evidence of active UC extending ≥15 cm from the anal verge via colonoscopy (confirmed by central read)
- •UCEIS score ≥ 4 with erosion/ulcer sub-score of ≥1 (confirmed by central read)
- •An inadequate response to, loss of response to, or intolerance to at least 1 of the following conventional therapies as defined below:
- •Oral 5-ASA compounds
- •Glucocorticoids (topical or systemic)
- •Thiopurines
- •If receiving oral 5-aminosalicylates (5-ASAs) or oral corticosteroids (≤20 mg prednisolone equivalent) for treatment of their UC, they must be on a stable dose for at least 28 days prior to randomization
- •Previous exposure to a single biologic agent, JAK inhibitor, or S1P inhibitor is allowed (not required) if it was discontinued for reasons other than primary no response. Discontinuation must have been more than 8 weeks or 5 half-lives (whichever is longer) prior to first dose of study treatment.
排除标准
- •Severe extensive colitis as evidenced by:
- •Likeliness to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within 12 weeks after randomization
- •Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation
- •Has severe UC during as defined by ≥6 bloody stools per day AND at least 1 of the following during Screening:
- •Pulse >90 bpm
- •Oral temperature of >37.8 °C
- •Hemoglobin <10.5 g/dL
- •CRP of >30 mg/L
- •Erythrocyte sedimentation rate >30 mm/h
- •Diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, acute diverticulitis, or the presence or history of a fistula consistent with CD based on medical history
- •History of or current evidence of colonic dysplasia; or recent history (within 2 years prior to randomization). Note: If adenomatous polyps present, must be completely removed per routine practice prior to the study participant's first dose of investigational product.
- •History of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy; or is planning to undergo bowel surgery during the course of the study.
- •History of spontaneous gastrointestinal (GI) perforation (other than appendicitis or mechanical injury), or at significantly increased risk of GI perforation based on the Investigator's judgment
研究组 & 干预措施
Placebo
Participants will receive 8 tablets of matching Placebo daily, via oral administration for 12 weeks
干预措施: Matching placebo (Drug)
Active TP317 80 mg
Participants will receive 8 tablets (80 mg) of TP317 daily, via oral administration for 12 weeks
干预措施: TP317 (Drug)
结局指标
主要结局
Safety of TP317
时间窗: Baseline through Week 12
Number of Participants with Clinically Significant Laboratory Abnormalities
Safety of TP317
时间窗: Baseline to Week 12
Changes in 12-lead electrocardiogram parameters
Pharmacokinetics of TP317
时间窗: Baseline through Week 12
Maximum observed plasma concentration (Cmax) of TP317
Safety of TP317
时间窗: Collected from baseline through Week 12
Incidence, duration and severity of all adverse events (AEs).
次要结局
未报告次要终点