NCT07845487招募中2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Induction and Maintenance Therapy With PALI-2108 in Participants With Moderately to Severely Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Palisade Bio
- 入组人数
- 204
- 试验地点
- 115
- 主要终点
- Proportion of participants with clinical remission using the 3-component modified Mayo Score (mMS) at Week 12.
研究概览
简要总结
The ASCENTRA-UC study is a phase 2 study testing PALI-2108 in patients with moderate to severe ulcerative colitis. Doses of drug will be compared against a placebo to see how well it works, how safe it is, and how the body responds to it.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Documented clinical diagnosis of UC for ≥ 3 months prior to Screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
- If a histopathology report is not available in the source records, a biopsy for a local histopathology evaluation (to obtain a report) can be obtained during the screening endoscopy procedure.
- Moderately to severely active UC, defined as:
- mMS of 5 to 9 (inclusive), AND
- ES ≥ 2, AND
- RB ≥ 1.
- Participants must satisfy at least one of the criteria listed under item a OR at least one of the criteria listed under item b: a. History of inadequate response or loss of response, or intolerance to at least one prior UC therapy, defined as: i. Oral prednisone ≥ 40 mg/day (or equivalent) or budesonide ≥ 9 mg/day for ≥ 2 weeks.
- ii. Corticosteroid dependence: unable to taper < 10 mg/day prednisone equivalent within 3 months, or relapse within 3 months of discontinuation.
- iii. Immunosuppressants: azathioprine ≥ 2 mg/kg/day, 6-mercaptopurine (6-MP) ≥ 1.0 mg/kg/day (or therapeutic 6-thioguanine nucleotide [6-TGN] level) for ≥ 12 weeks, or methotrexate ≥ 15 mg/week subcutaneous or intramuscular.
- iv. Approved advanced therapies at the approved labelled dose:
- Anti-tumor necrosis factor (TNF), anti-integrin (vedolizumab), or anti-IL-12/23 for at least 8 weeks; anti-IL 23 for at least 12 weeks.
- Janus kinase (JAK) inhibitor for at least 8 weeks; sphingosine-1-phosphate receptor (S1PR) modulator for at least 12 weeks.
- Note: Demonstration of intolerance requires no minimum dose nor duration of use.
- b. Currently receiving one or more of the following treatments: i. Stable oral prednisone at ≤ 20 mg/day (or equivalent) or budesonide ≤ 9 mg for ≥ 2 weeks prior to randomization.
- ii. Stable dose of thiopurine (azathioprine or 6-MP) for ≥ 4 weeks prior to randomization, and have started the treatment ≥ 12 weeks prior to randomization.
- iii. Stable dose of oral aminosalicylates for ≥ 2 weeks prior to randomization.
- Key
排除标准
- Diagnosis of Crohn's disease or IBD-Unclassified (IBD-U; indeterminate colitis) or a history of ischemic colitis or radiation colitis.
- UC limited to rectum (< 15 cm from anal verge).
- Any prior history of suicidal behavior (actual, interrupted, aborted attempt, or preparatory acts).
- Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation type 4 or 5, or any active suicidal ideation with some intent to act.
- Severe depression at Screening based on a validated scale threshold (e.g., Patient Health Questionnaire-9 [PHQ-9] ≥ 20, or PHQ-9 item 9 > 0) at Screening.
- Failure or intolerance of > 3 classes of approved advanced therapies or > 4 approved individual advanced therapies.
研究组 & 干预措施
Placebo
Placebo Comparator
QD
干预措施: Placebo (Drug)
PALI-2108 Dose 1
Experimental
15mg QD
干预措施: PALI-2108 (Drug)
PALI-2108 Dose 2
Experimental
30mg QD
干预措施: PALI-2108 (Drug)
结局指标
主要结局
Proportion of participants with clinical remission using the 3-component modified Mayo Score (mMS) at Week 12.
时间窗: Week 12
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
次要结局
- Proportion of participants with clinical response using 3-component mMS at Week 12.(At 12 weeks)
- Proportion of participants with endoscopic improvement at Week 12.(Week 12)
- Proportion of participants with HEMI at Week 12.(Week 12)
- Proportion of participants with clinical remission using the 3-component mMS at Week 48.(Week 48)
- Proportion of participants with endoscopic improvement at Week 48.(Week 48)
- Proportion of participants with HEMI at Week 48(Week48)
研究者
研究点 (115)
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标识符
- NCT 编号
- NCT07845487
- 其他研究编号
- PBI-2108-202
日期
- 首次提交
- (9天前)
- 首次发布
- (昨天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否
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