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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

16 сентября 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

2000

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Экспериментальный: 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.
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Экспериментальный: 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.
Лекарство: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • ABBV-382
Экспериментальный: 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.
Лекарство: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • ABBV-382
Экспериментальный: 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.
Лекарство: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • ABBV-382
Экспериментальный: 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.
Лекарство: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • ABBV-382
Экспериментальный: 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
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Лекарство: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • ABBV-382
Экспериментальный: 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
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Лекарство: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • ABBV-382
Экспериментальный: 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
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Лекарство: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • ABBV-382
Экспериментальный: 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
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Лекарство: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • ABBV-382
Экспериментальный: 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.
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Экспериментальный: 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.
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Экспериментальный: 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.
Лекарство: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Экспериментальный: 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.
Лекарство: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Экспериментальный: 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.
Лекарство: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Экспериментальный: 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.
Лекарство: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Экспериментальный: 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.
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Лекарство: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Экспериментальный: 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.
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Лекарство: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Экспериментальный: 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.
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Лекарство: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Экспериментальный: 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.
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Лекарство: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Экспериментальный: 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
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Лекарство: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Экспериментальный: 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
Лекарство: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Другие имена:
  • АББВ-066
Лекарство: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

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Спонсор

AbbVie

Следователи

  • Директор по исследованиям: ABBVIE INC., AbbVie

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

31 июля 2026 г.

Первичное завершение (Оцененный)

1 октября 2031 г.

Завершение исследования (Оцененный)

1 октября 2031 г.

Даты регистрации исследования

Первый отправленный

7 июля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

7 июля 2026 г.

Первый опубликованный (Действительный)

13 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

18 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

16 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • M26-266
  • 2026-525960-16-00 (Другой идентификатор: EU CT)
  • 2026-525959-86-00 (Ктис)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Сроки обмена IPD

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Критерии совместного доступа к IPD

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Да

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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