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Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

2026年9月16日 更新者：AbbVie

A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC).

This study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide.

There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.

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)

2000

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。

学习联系方式

学习地点

  • 台湾
      • Taichung、台湾、40447
        • 招聘中
        • China Medical University Hospital /ID# 280630
  • 美国
    • Alabama
      • Dothan、Alabama、美国、36301
        • 招聘中
        • Digestive Health Specialists /ID# 280827
    • Arizona
      • Phoenix、Arizona、美国、85018
        • 招聘中
        • Elite Clinical Studies /ID# 280477
        • 接触：
          • Site Coordinator
          • 电话号码：602-788-3437
      • Sun City、Arizona、美国、85351
        • 招聘中
        • Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
    • California
      • Anaheim、California、美国、92805
        • 招聘中
        • Clinnova Research /ID# 280509
      • Coronado、California、美国、92118
        • 招聘中
        • Southern California Res. Ctr /ID# 280476
      • Lancaster、California、美国、93534
        • 招聘中
        • Gastro Care Institute /ID# 281071
      • Los Alamitos、California、美国、90720
        • 招聘中
        • United Medical Doctors - Los Alamitos /ID# 281125
      • Rialto、California、美国、92377
        • 招聘中
        • Inland Empire Liver Foundation - Rialto /ID# 280775
    • Colorado
      • Colorado Springs、Colorado、美国、80907
        • 招聘中
        • Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
    • Florida
      • Kissimmee、Florida、美国、34741
        • 招聘中
        • Clinical Research of Osceola /ID# 280593
      • Miami、Florida、美国、33134
        • 招聘中
        • Research Associates of South Florida /ID# 280929
        • 接触：
          • Site Coordinator
          • 电话号码：786-476-8790
      • New Port Richey、Florida、美国、34653
        • 招聘中
        • Advanced Research Institute, Inc /ID# 281062
        • 接触：
          • Site Coordinator
          • 电话号码：727-835-3261
      • Orlando、Florida、美国、32825
        • 招聘中
        • Digestive And Liver Center Of Florida - Orlando /ID# 280924
    • Georgia
      • Macon、Georgia、美国、31201
        • 招聘中
        • Gastroenterology Associates of Central Georgia /ID# 280464
      • Roswell、Georgia、美国、30076
        • 招聘中
        • Gastroenterology Consultants - Roswell /ID# 281235
        • 接触：
          • Site Coordinator
          • 电话号码：404-596-4480
    • Idaho
      • Boise、Idaho、美国、83706
        • 招聘中
        • Treasure Valley Medical Research /ID# 281778
    • Illinois
      • Gurnee、Illinois、美国、60031
        • 招聘中
        • Illinois Gastroenterology Group /ID# 283933
        • 接触：
          • Site Coordinator
          • 电话号码：224-441-2217
      • Oak Lawn、Illinois、美国、60453
        • 招聘中
        • Southwest Gastroenterology - Oak Lawn /ID# 280841
    • Kentucky
      • Louisville、Kentucky、美国、40218
        • 招聘中
        • Gastroenterology Health Partners /ID# 284144
    • Louisiana
      • Shreveport、Louisiana、美国、71103
        • 招聘中
        • Willis-Knighton Medical Center /ID# 280572
        • 接触：
          • Site Coordinator
          • 电话号码：318-212-2863
    • Mississippi
      • Flowood、Mississippi、美国、39232
        • 招聘中
        • Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967
    • Missouri
      • St Louis、Missouri、美国、63141
        • 招聘中
        • Specialists In Gastroenterology /ID# 283939
    • Nevada
      • Las Vegas、Nevada、美国、89128
        • 招聘中
        • Vector Clinical Trials /ID# 280843
    • New York
      • New York、New York、美国、10075
        • 招聘中
        • New York Gastroenterology Associates - Upper East Side /ID# 281767
    • Ohio
      • Englewood、Ohio、美国、45415
        • 招聘中
        • Dayton Gastroenterology - Englewood /ID# 284065
      • Westlake、Ohio、美国、44145
        • 招聘中
        • Gastro Intestinal Research Institute of Northern Ohio /ID# 283860
    • Rhode Island
      • Providence、Rhode Island、美国、02905
        • 招聘中
        • University Gastroenterology - Providence - Staniford Street /ID# 280919
    • Tennessee
      • Memphis、Tennessee、美国、38104
        • 招聘中
        • Gastro One - Memphis /ID# 283948
    • Texas
      • Bellaire、Texas、美国、77401
        • 招聘中
        • Novel Research - Bellaire /ID# 280925
      • Georgetown、Texas、美国、78628
        • 招聘中
        • Amel Med /ID# 283864
      • Houston、Texas、美国、77090
        • 招聘中
        • Integrity Advanced Therapeutics /ID# 283871
      • San Antonio、Texas、美国、78229
        • 招聘中
        • Southern Star Research Institute /ID# 280822
    • Washington
      • Bellevue、Washington、美国、98004
        • 招聘中
        • Washington Gastroenterology - Bellevue /ID# 283966
      • Tacoma、Washington、美国、98405
        • 招聘中
        • Washington Gastroenterology - Tacoma /ID# 284143
      • Vancouver、Washington、美国、98664
        • 招聘中
        • The Vancouver Clinic /ID# 280497
        • 接触：
          • Site Coordinator
          • 电话号码：360-397-3388

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

CD specific:

  • Crohn's Disease Activity Index (CDAI) score of ≥ 220
  • Confirmed diagnosis of CD at least 90 days prior to Baseline
  • Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.
  • Demonstrated failure of 1 or more therapy for CD

UC specific:

  • Confirmed diagnosis of UC at least 90 days prior to Baseline
  • Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3
  • Demonstrated failure of 1 or more therapy for UC

Exclusion Criteria:

  • Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)
  • Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment
  • Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame
  • Participants with surgical bowel resection within the past 3 months prior to Baseline

CD specific:

  • Participants with >3 prior bowel resections
  • Participants with previous small bowel resection(s) of combined length >100 cm

UC specific:

  • Participants with prior colectomy (total or subtotal)
  • Participants with extent of disease limited to < 10 cm of rectum

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Substudy 1: UC Arm 1 Risankizumab monotherapy
Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
实验性的：Substudy 1: CD Arm 1 Risankizumab monotherapy
Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
实验性的：Substudy 1: UC Arm 2 Trosunilimab monotherapy
Ulcerative Colitis (UC) participants will receive Trosunilimab Dose A as induction treatment followed by Trosunilimab Dose C as maintenance treatment.
药品：Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-382
实验性的：Substudy 1: CD Arm 2 Trosunilimab monotherapy
Crohn's Disease (CD) participants will receive Trosunilimab Dose B as induction treatment followed by Trosunilimab Dose D as maintenance treatment.
药品：Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-382
实验性的：Substudy 1: UC Arm 3 Trosunilimab monotherapy
Ulcerative Colitis (UC) participants will receive Trosunilimab Dose E as induction treatment followed by Trosunilimab Dose G as maintenance treatment.
药品：Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-382
实验性的：Substudy 1: CD Arm 3 Trosunilimab monotherapy
Crohn's Disease (CD) participants will receive Trosunilimab Dose F as induction treatment followed by Trosunilimab Dose H as maintenance treatment.
药品：Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-382
实验性的：Substudy 1: UC Arm 4 ABBV-466 (Risankizumab/Trosunilimab)
Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose A followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose C
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
药品：Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-382
实验性的：Substudy 1: CD Arm 4 ABBV-466 (Risankizumab/Trosunilimab)
Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose B followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose D
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
药品：Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-382
实验性的：Substudy 1: UC Arm 5 ABBV-466 (Risankizumab/Trosunilimab)
Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose E followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose G
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
药品：Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-382
实验性的：Substudy 1: CD Arm 5 ABBV-466 (Risankizumab/Trosunilimab)
Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab/Trosunilimab) combo Dose F followed by a combination maintenance (Risankizumab/Trosunilimab) combo Dose H
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
药品：Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-382
实验性的：Substudy 2: UC Arm 1 Risankizumab monotherapy
Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
实验性的：Substudy 2: CD Arm 1 Risankizumab monotherapy
Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
实验性的：Substudy 2: UC Arm 2 ABBV-701 monotherapy
Ulcerative Colitis (UC) participants will receive ABBV-701 Dose A as induction treatment and Dose C maintenance treatment.
药品：ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
实验性的：Substudy 2: CD Arm 2 ABBV-701 monotherapy
Crohn's Disease (CD) participants will receive ABBV-701 Dose B as induction treatment and Dose D maintenance treatment.
药品：ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
实验性的：Substudy 2: UC Arm 3 ABBV-701 monotherapy
Ulcerative Colitis (UC) participants will receive ABBV-701 Dose E as induction treatment and Dose G maintenance treatment.
药品：ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
实验性的：Substudy 2: CD Arm 3 ABBV-701 monotherapy
Crohn's Disease (CD) participants will receive ABBV-701 Dose F as induction treatment and Dose H maintenance treatment.
药品：ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
实验性的：Substudy 2: UC Arm 4 ABBV-7066 (Risankizumab/ABBV-701)
Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose A followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose C.
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
药品：ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
实验性的：Substudy 2: CD Arm 4 ABBV-7066 (Risankizumab/ABBV-701)
Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose B followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose D.
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
药品：ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
实验性的：Substudy 2: UC Arm 5 ABBV-7066 (Risankizumab/ABBV-701)
Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose E followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose G.
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
药品：ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
实验性的：Substudy 2: CD Arm 5 ABBV-7066 (Risankizumab/ABBV-701)
Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose F followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose H.
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
药品：ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
实验性的：Substudy 2: UC Arm 6 ABBV-7066 (Risankizumab/ABBV-701)
Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose I followed by maintenance treatment of ABBV-7066 (Risankizumab/ABBV-701) combination Dose J
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
药品：ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
实验性的：Substudy 2: CD Arm 6 ABBV-7066 (Risankizumab/ABBV-701)
Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab/ ABBV-701) combination Dose K followed by maintenance treatment of ABBV-7066 (Risankizumab/ ABBV-701) combination Dose L
药品：Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
其他名称：
  • ABBV-066
药品：ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion

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
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
大体时间：At Week 28
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
At Week 28
Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission
大体时间：At Week 28
Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
At Week 28
Number of Participants with Adverse Events (AEs)
大体时间：Up to 98 Weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Up to 98 Weeks

次要结果测量

结果测量
措施说明
大体时间
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
大体时间：At Week 12
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
At Week 12
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response
大体时间：At Week 12
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Response is defined as a decrease in SES-CD > 50% from Baseline, and/or endoscopic remission, as scored by central reader.
At Week 12
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response
大体时间：At Week 28
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Response is defined as a decrease in SES-CD > 50% from Baseline, and/or endoscopic remission, as scored by central reader.
At Week 28
Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission
大体时间：At Week 12
Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
At Week 12
Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission
大体时间：At Week 28
Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
At Week 28
Crohn's Disease Specific: Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)
大体时间：At Week 12
SF/APS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.
At Week 12
Crohn's Disease Specific: Percentage of Participants With Clinical Remission Per Stool Frequency/Abdominal Pain Score (SF/APS)
大体时间：At Week 28
SF/APS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.
At Week 28
Ulcerative Colitis Specific: Percentage of Participants with Clinical Remission per modified Mayo Score (mMS)
大体时间：At Week 12
Clinical remission on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore <= 1, AND not greater than baseline. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
At Week 12
Ulcerative Colitis Specific: Percentage of Participants with Clinical Remission per mMS
大体时间：At Week 28
Clinical remission on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore <= 1, AND not greater than baseline. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
At Week 28
Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission
大体时间：At Week 12
Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
At Week 12
Ulcerative Colitis Specific: Percentage of Participants Achieving Endoscopic Improvement
大体时间：At Week 12
Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
At Week 12
Ulcerative Colitis Specific: Percentage of Participants Achieving Endoscopic Improvement
大体时间：At Week 28
Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
At Week 28
Ulcerative Colitis Specific: Percentage of Participants who Achieve Clinical Response Per mMS
大体时间：At Week 12
Clinical response per mMS is defined as decrease from baseline >=2 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
At Week 12
Ulcerative Colitis Specific: Percentage of Participants who Achieve Clinical Response Per mMS
大体时间：At Week 28
Clinical response per mMS is defined as decrease from baseline >=2 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.
At Week 28

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AbbVie

调查人员

  • 研究主任：ABBVIE INC.、AbbVie

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7月31日

初级完成 (估计的)

2031年10月1日

研究完成 (估计的)

2031年10月1日

研究注册日期

首次提交

2026年7月7日

首先提交符合 QC 标准的

2026年7月7日

首次发布 (实际的)

2026年7月13日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月16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

  • M26-266
  • 2026-525960-16-00 (其他标识符：EU CT)
  • 2026-525959-86-00 (克蒂斯)

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是的

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IPD 共享支持信息类型

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  • 树液

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

在美国制造并从美国出口的产品

是的

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