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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. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

2000

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Eksperimentel: 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.
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Eksperimentel: 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.
Medicin: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-382
Eksperimentel: 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.
Medicin: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-382
Eksperimentel: 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.
Medicin: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-382
Eksperimentel: 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.
Medicin: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-382
Eksperimentel: 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
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Medicin: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-382
Eksperimentel: 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
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Medicin: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-382
Eksperimentel: 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
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Medicin: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-382
Eksperimentel: 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
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Medicin: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-382
Eksperimentel: 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.
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Eksperimentel: 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.
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Eksperimentel: 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.
Medicin: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperimentel: 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.
Medicin: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperimentel: 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.
Medicin: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperimentel: 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.
Medicin: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperimentel: 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.
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Medicin: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperimentel: 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.
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Medicin: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperimentel: 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.
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Medicin: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperimentel: 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.
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Medicin: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperimentel: 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
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Medicin: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Eksperimentel: 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
Medicin: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
  • ABBV-066
Medicin: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AbbVie

Efterforskere

  • Studieleder: ABBVIE INC., AbbVie

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

24. juli 2026

Primær færdiggørelse (Anslået)

1. oktober 2031

Studieafslutning (Anslået)

1. oktober 2031

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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