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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

7 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

2000

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Afryka Południowa
    • Gauteng
      • Johannesburg, Gauteng, Afryka Południowa, 1821
        • Lenasia Clinical Trial Centre - Johannesburg /ID# 281415
      • Johannesburg, Gauteng, Afryka Południowa, 1864
        • Chris Hani Baragwanath Hospital /ID# 284122
    • Western Cape
      • George, Western Cape, Afryka Południowa, 6529
        • Excellentis Clinical Trial Consultants /ID# 282430
  • Australia
    • New South Wales
      • Macquarie University, New South Wales, Australia, 02109
        • Macquarie Hospital /ID# 281739
      • Newcastle, New South Wales, Australia, 2305
        • John Hunter Hospital /ID# 282537
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Hospital Brisbane /ID# 281738
      • Southport, Queensland, Australia, 4215
        • Gold Coast Hospital /ID# 282434
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health - Monash Medical Centre - Clayton /ID# 281711
  • Belgia
      • Liège, Belgia, 4000
        • CHU de Liege /ID# 281182
    • Antwerpen
      • Edegem, Antwerpen, Belgia, 2650
        • Universitair Ziekenhuis Antwerpen /ID# 282218
    • Hainaut
      • Lodelinsart, Hainaut, Belgia, 6042
        • Chu De Charleroi - Hopital Civil Marie Curie /ID# 281632
    • Namur
      • Yvoir, Namur, Belgia, 5530
        • Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 281312
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgia, 8800
        • AZ-Delta. /ID# 281031
  • Hiszpania
      • Córdoba, Hiszpania, 14004
        • Hospital Universitario Reina Sofia /ID# 281446
      • Valladolid, Hiszpania, 47012
        • Hospital Rio Hortega /ID# 281426
    • Vizcaya
      • Galdakao, Vizcaya, Hiszpania, 48960
        • Hospital Galdakao-Usansolo /ID# 280388
  • Japonia
    • Iwate
      • Shiwa-gun, Iwate, Japonia, 028-3695
        • Iwate Medical University Hospital /ID# 282387
    • Miyagi
      • Sendai, Miyagi, Japonia, 981-3213
        • Takagi Clinic - Sendai /ID# 281805
  • Niemcy
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Niemcy, 72076
        • Universitaetsklinikum Tuebingen /ID# 282958
  • Stany Zjednoczone
    • Florida
      • Lakeland, Florida, Stany Zjednoczone, 33813
        • Auzmer Research /ID# 280786
      • Miami, Florida, Stany Zjednoczone, 33176
        • Gastro Health - Miami /ID# 282001
    • Maine
      • Portland, Maine, Stany Zjednoczone, 04102
        • Portland Gastroenterology Center - Portland - Congress Street /ID# 281970
    • New Jersey
      • Hackensack, New Jersey, Stany Zjednoczone, 07601
        • Hackensack Meridian Health - Hackensack University Medical Center /ID# 281865
    • New York
      • New York, New York, Stany Zjednoczone, 11428
        • Queens Village Primary Medical Center /ID# 281857
    • Ohio
      • Brunswick, Ohio, Stany Zjednoczone, 44212
        • Digestive Disease Consultants - Brunswick /ID# 283935
    • Tennessee
      • Jackson, Tennessee, Stany Zjednoczone, 38301
        • Skyline Gastroenterology of West Tennessee /ID# 284146
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78731
        • Texas Digestive Disease Consultants /ID# 284159
      • San Marcos, Texas, Stany Zjednoczone, 78666
        • Gi Alliance - Texas Digestive Disease Consultants - San Marcos /ID# 283947
  • Szwajcaria
    • Canton of Zurich
      • Zurich, Canton of Zurich, Szwajcaria, 8091
        • University Hospital Zurich /ID# 280548
  • Słowenia
      • Maribor, Słowenia, 2000
        • University Medical Centre Maribor /ID# 281175

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Eksperymentalny: 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.
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Eksperymentalny: 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.
Lek: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-382
Eksperymentalny: 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.
Lek: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-382
Eksperymentalny: 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.
Lek: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-382
Eksperymentalny: 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.
Lek: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-382
Eksperymentalny: 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
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Lek: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-382
Eksperymentalny: 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
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Lek: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-382
Eksperymentalny: 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
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Lek: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-382
Eksperymentalny: 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
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Lek: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-382
Eksperymentalny: 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.
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Eksperymentalny: 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.
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Eksperymentalny: 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.
Lek: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperymentalny: 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.
Lek: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperymentalny: 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.
Lek: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperymentalny: 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.
Lek: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperymentalny: 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.
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Lek: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperymentalny: 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.
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Lek: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperymentalny: 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.
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Lek: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperymentalny: 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.
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Lek: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperymentalny: 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
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Lek: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperymentalny: 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
Lek: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Inne nazwy:
  • ABBV-066
Lek: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AbbVie

Śledczy

  • Dyrektor Studium: ABBVIE INC., AbbVie

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

24 lipca 2026

Zakończenie podstawowe (Szacowany)

1 października 2031

Ukończenie studiów (Szacowany)

1 października 2031

Daty rejestracji na studia

Pierwszy przesłany

7 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 lipca 2026

Pierwszy wysłany (Rzeczywisty)

13 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • M26-266
  • 2026-525960-16-00 (Inny identyfikator: EU CT)
  • 2026-525959-86-00 (Ctis)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Choroba Crohna

Badania kliniczne na Risankizumab

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Guatemala

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

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