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A Trial to Investigate PALI-2108 Versus Placebo in Participants With Moderately to Severely Active Ulcerative Colitis (ASCENTRA-UC)

2026年10月20日 更新者：Palisade Bio

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

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

204

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 乔治亚州
    • Quebec
      • Batumi、Quebec、乔治亚州、6010
      • Tbilisi、Quebec、乔治亚州、0102
      • Tbilisi、Quebec、乔治亚州、0144
      • Tbilisi、Quebec、乔治亚州、0159
      • Tbilisi、Quebec、乔治亚州、0160
      • Tbilisi、Quebec、乔治亚州、0178
      • Tbilisi、Quebec、乔治亚州、0180
      • Tbilisi、Quebec、乔治亚州、0180
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4L7
      • Edmonton、Alberta、加拿大、T6K 4E8
    • Ontario
      • Greater Sudbury、Ontario、加拿大、P3C1X3
      • London、Ontario、加拿大、N6K 1M6
      • Scarborough Village、Ontario、加拿大、M1B3V4
    • Quebec
      • Montreal、Quebec、加拿大、H1T 2M4
      • Montreal、Quebec、加拿大、H2X 3E4
  • 匈牙利
      • Budapest、匈牙利、1024
      • Budapest、匈牙利、H-1062
      • Budapest、匈牙利、H-1088
      • Debrecen、匈牙利、H-4025
      • Gyöngyös、匈牙利、H-3200
      • Tatabánya、匈牙利、H-2800
      • Veszprém、匈牙利、8200
  • 塞尔维亚
      • Belgrade、塞尔维亚、11 000
      • Belgrade、塞尔维亚、11 080
      • Belgrade、塞尔维亚、11000
      • Leskovac、塞尔维亚、16000
      • Užice、塞尔维亚、31000
      • Zrenjanin、塞尔维亚、23 000
  • 意大利
      • Bari、意大利、70124
      • Bologna、意大利、40138
      • Matera、意大利、75100
      • Negrar、意大利、37024
      • Rome、意大利、00128
      • Rome、意大利、00133
      • Rome、意大利、00168
      • Rozzano、意大利、20089
      • San Giovanni Rotondo、意大利、71013
      • Turin、意大利、10126
  • 拉脱维亚
      • Liepāja、拉脱维亚、LV-3414
      • Riga、拉脱维亚、LV-1002
      • Riga、拉脱维亚、LV-1012
  • 捷克语
      • Brno、捷克语、602 00
      • Brno、捷克语、615 00
      • Havířov、捷克语、736 01
      • Hradec Králové、捷克语、500 12
      • Prague、捷克语、150 00
      • Slaný、捷克语、274 01
  • 斯洛伐克
      • Banská Bystrica、斯洛伐克、975 17
      • Košice、斯洛伐克、040 13
      • Prešov、斯洛伐克、080 01
      • Prešov、斯洛伐克、080 01
      • Zvolen、斯洛伐克、960 01
  • 法国
      • Amiens、法国、80000
      • Clermont-Ferrand、法国、63003
      • Neuilly-sur-Seine、法国、92200
      • Nice、法国、06200
      • Saint-Priest-en-Jarez、法国、42270
  • 波兰
      • Bydgoszcz、波兰、85-794
      • Elblag、波兰、82-300
      • Katowice、波兰、40-748
      • Kielce、波兰、25-375
      • Krakow、波兰、30-363
      • Krakow、波兰、31-228
      • Kłodzko、波兰、57-300
      • Lodz、波兰、91-495
      • Lublin、波兰、20-582
      • Nowy Targ、波兰、34-400
      • Opole、波兰、45-819
      • Poznan、波兰、60-529
      • Sopot、波兰、81-756
      • Staszów、波兰、28-200
      • Szczecin、波兰、71-434
      • Szczecin、波兰、71-685
      • Torun、波兰、87-100
      • Tychy、波兰、43-100
      • Warsaw、波兰、00-189
      • Warsaw、波兰、04-501
      • Wroclaw、波兰、52-416
      • Wroclaw、波兰、53-611
  • 罗马尼亚
      • Bucharest、罗马尼亚、020125
      • Bucharest、罗马尼亚、021967
      • Constanța、罗马尼亚、900663
      • Ploieşti、罗马尼亚、100032
      • Timișoara、罗马尼亚、300002
      • Timișoara、罗马尼亚、300239
  • 美国
    • Arizona
      • Sun City、Arizona、美国、85351
    • California
      • San Diego、California、美国、92103
    • Connecticut
      • Bristol、Connecticut、美国、06010
    • Florida
      • Orlando、Florida、美国、32825
    • Illinois
      • Des Plaines、Illinois、美国、60016
      • Glenview、Illinois、美国、60026
      • Gurnee、Illinois、美国、60031
    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
      • Mandeville、Louisiana、美国、70471
    • Mississippi
      • Tupelo、Mississippi、美国、38801
    • Missouri
      • St Louis、Missouri、美国、63141
    • New Jersey
      • Clifton、New Jersey、美国、07013
    • New York
      • Albany、New York、美国、12206
      • Rochester、New York、美国、14618
    • Ohio
      • Brunswick、Ohio、美国、44212
      • Dayton、Ohio、美国、45415
      • Westlake、Ohio、美国、44145
    • Rhode Island
      • Providence、Rhode Island、美国、02905
    • Tennessee
      • Cordova、Tennessee、美国、38018
    • Texas
      • Garland、Texas、美国、75044
      • Georgetown、Texas、美国、78628
      • Houston、Texas、美国、77024
      • Lubbock、Texas、美国、79424
      • Mansfield、Texas、美国、760063
      • Southlake、Texas、美国、76092
      • Tyler、Texas、美国、75701
    • Virginia
      • Richmond、Virginia、美国、23229
    • Washington
      • Bellevue、Washington、美国、98004
      • Tacoma、Washington、美国、98405
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53215

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Key Inclusion Criteria:

  • 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:

  1. 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.
  2. 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 Exclusion Criteria:• 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：PALI-2108 Dose 1

15mg QD
药品：PALI-2108

Oral Dose
实验性的：PALI-2108 Dose 2

30mg QD
药品：PALI-2108

Oral Dose
安慰剂比较：Placebo

QD
药品：Placebo

Oral Dose

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of participants with clinical remission using the 3-component modified Mayo Score (mMS) at Week 12.
大体时间：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.
Week 12

次要结果测量

结果测量
措施说明
大体时间
Proportion of participants with clinical response using 3-component mMS at Week 12.
大体时间：At 12 weeks

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.
At 12 weeks
Proportion of participants with endoscopic improvement at Week 12.
大体时间：Week 12

Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Week 12
Proportion of participants with HEMI at Week 12.
大体时间：Week 12

HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Week 12
Proportion of participants with clinical remission using the 3-component mMS at Week 48.
大体时间：Week 48

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.
Week 48
Proportion of participants with endoscopic improvement at Week 48.
大体时间：Week 48

Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Week 48
Proportion of participants with HEMI at Week 48
大体时间：Week48

HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Week48

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Palisade Bio

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月28日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年9月21日

首先提交符合 QC 标准的

2026年9月22日

首次发布 (实际的)

2026年9月29日

研究记录更新

最后更新发布 (实际的)

2026年10月21日

上次提交的符合 QC 标准的更新

2026年10月20日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PBI-2108-202

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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