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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 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

2000

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • 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
  • Deutschland
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Deutschland, 72076
        • Universitaetsklinikum Tuebingen /ID# 282958
  • 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
  • Slowenien
      • Maribor, Slowenien, 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
  • Südafrika
    • Gauteng
      • Johannesburg, Gauteng, Südafrika, 1821
        • Lenasia Clinical Trial Centre - Johannesburg /ID# 281415
      • Johannesburg, Gauteng, Südafrika, 1864
        • Chris Hani Baragwanath Hospital /ID# 284122
    • Western Cape
      • George, Western Cape, Südafrika, 6529
        • Excellentis Clinical Trial Consultants /ID# 282430
  • Vereinigte Staaten
    • Florida
      • Lakeland, Florida, Vereinigte Staaten, 33813
        • Auzmer Research /ID# 280786
      • Miami, Florida, Vereinigte Staaten, 33176
        • Gastro Health - Miami /ID# 282001
    • Maine
      • Portland, Maine, Vereinigte Staaten, 04102
        • Portland Gastroenterology Center - Portland - Congress Street /ID# 281970
    • New Jersey
      • Hackensack, New Jersey, Vereinigte Staaten, 07601
        • Hackensack Meridian Health - Hackensack University Medical Center /ID# 281865
    • New York
      • New York, New York, Vereinigte Staaten, 11428
        • Queens Village Primary Medical Center /ID# 281857
    • Ohio
      • Brunswick, Ohio, Vereinigte Staaten, 44212
        • Digestive Disease Consultants - Brunswick /ID# 283935
    • Tennessee
      • Jackson, Tennessee, Vereinigte Staaten, 38301
        • Skyline Gastroenterology of West Tennessee /ID# 284146
    • Texas
      • Austin, Texas, Vereinigte Staaten, 78731
        • Texas Digestive Disease Consultants /ID# 284159
      • San Marcos, Texas, Vereinigte Staaten, 78666
        • Gi Alliance - Texas Digestive Disease Consultants - San Marcos /ID# 283947

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Experimental: 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.
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Experimental: 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.
Arzneimittel: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-382
Experimental: 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.
Arzneimittel: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-382
Experimental: 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.
Arzneimittel: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-382
Experimental: 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.
Arzneimittel: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-382
Experimental: 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
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Arzneimittel: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-382
Experimental: 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
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Arzneimittel: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-382
Experimental: 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
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Arzneimittel: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-382
Experimental: 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
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Arzneimittel: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-382
Experimental: 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.
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Experimental: 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.
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Experimental: 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.
Arzneimittel: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: 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.
Arzneimittel: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: 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.
Arzneimittel: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: 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.
Arzneimittel: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: 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.
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Arzneimittel: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: 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.
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Arzneimittel: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: 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.
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Arzneimittel: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: 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.
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Arzneimittel: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: 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
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Arzneimittel: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimental: 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
Arzneimittel: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere Namen:
  • ABBV-066
Arzneimittel: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AbbVie

Ermittler

  • Studienleiter: ABBVIE INC., AbbVie

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

24. Juli 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2031

Studienabschluss (Geschätzt)

1. Oktober 2031

Studienanmeldedaten

Zuerst eingereicht

7. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juli 2026

Zuerst gepostet (Tatsächlich)

13. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

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JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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