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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 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

2000

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • 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
  • Belgio
      • Liège, Belgio, 4000
        • CHU de Liege /ID# 281182
    • Antwerpen
      • Edegem, Antwerpen, Belgio, 2650
        • Universitair Ziekenhuis Antwerpen /ID# 282218
    • Hainaut
      • Lodelinsart, Hainaut, Belgio, 6042
        • Chu De Charleroi - Hopital Civil Marie Curie /ID# 281632
    • Namur
      • Yvoir, Namur, Belgio, 5530
        • Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 281312
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgio, 8800
        • AZ-Delta. /ID# 281031
  • Germania
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germania, 72076
        • Universitaetsklinikum Tuebingen /ID# 282958
  • Giappone
    • Iwate
      • Shiwa-gun, Iwate, Giappone, 028-3695
        • Iwate Medical University Hospital /ID# 282387
    • Miyagi
      • Sendai, Miyagi, Giappone, 981-3213
        • Takagi Clinic - Sendai /ID# 281805
  • Slovenia
      • Maribor, Slovenia, 2000
        • University Medical Centre Maribor /ID# 281175
  • Spagna
      • Córdoba, Spagna, 14004
        • Hospital Universitario Reina Sofia /ID# 281446
      • Valladolid, Spagna, 47012
        • Hospital Rio Hortega /ID# 281426
    • Vizcaya
      • Galdakao, Vizcaya, Spagna, 48960
        • Hospital Galdakao-Usansolo /ID# 280388
  • Stati Uniti
    • Florida
      • Lakeland, Florida, Stati Uniti, 33813
        • Auzmer Research /ID# 280786
      • Miami, Florida, Stati Uniti, 33176
        • Gastro Health - Miami /ID# 282001
    • Maine
      • Portland, Maine, Stati Uniti, 04102
        • Portland Gastroenterology Center - Portland - Congress Street /ID# 281970
    • New Jersey
      • Hackensack, New Jersey, Stati Uniti, 07601
        • Hackensack Meridian Health - Hackensack University Medical Center /ID# 281865
    • New York
      • New York, New York, Stati Uniti, 11428
        • Queens Village Primary Medical Center /ID# 281857
    • Ohio
      • Brunswick, Ohio, Stati Uniti, 44212
        • Digestive Disease Consultants - Brunswick /ID# 283935
    • Tennessee
      • Jackson, Tennessee, Stati Uniti, 38301
        • Skyline Gastroenterology of West Tennessee /ID# 284146
    • Texas
      • Austin, Texas, Stati Uniti, 78731
        • Texas Digestive Disease Consultants /ID# 284159
      • San Marcos, Texas, Stati Uniti, 78666
        • Gi Alliance - Texas Digestive Disease Consultants - San Marcos /ID# 283947
  • Sud Africa
    • Gauteng
      • Johannesburg, Gauteng, Sud Africa, 1821
        • Lenasia Clinical Trial Centre - Johannesburg /ID# 281415
      • Johannesburg, Gauteng, Sud Africa, 1864
        • Chris Hani Baragwanath Hospital /ID# 284122
    • Western Cape
      • George, Western Cape, Sud Africa, 6529
        • Excellentis Clinical Trial Consultants /ID# 282430
  • Svizzera
    • Canton of Zurich
      • Zurich, Canton of Zurich, Svizzera, 8091
        • University Hospital Zurich /ID# 280548

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Sperimentale: 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.
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Sperimentale: 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.
Droga: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-382
Sperimentale: 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.
Droga: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-382
Sperimentale: 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.
Droga: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-382
Sperimentale: 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.
Droga: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-382
Sperimentale: 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
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Droga: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-382
Sperimentale: 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
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Droga: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-382
Sperimentale: 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
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Droga: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-382
Sperimentale: 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
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Droga: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-382
Sperimentale: 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.
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Sperimentale: 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.
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Sperimentale: 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.
Droga: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Sperimentale: 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.
Droga: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Sperimentale: 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.
Droga: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Sperimentale: 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.
Droga: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Sperimentale: 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.
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Droga: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Sperimentale: 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.
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Droga: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Sperimentale: 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.
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Droga: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Sperimentale: 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.
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Droga: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Sperimentale: 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
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Droga: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Sperimentale: 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
Droga: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Altri nomi:
  • ABBV-066
Droga: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AbbVie

Investigatori

  • Direttore dello studio: ABBVIE INC., AbbVie

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

24 luglio 2026

Completamento primario (Stimato)

1 ottobre 2031

Completamento dello studio (Stimato)

1 ottobre 2031

Date di iscrizione allo studio

Primo inviato

7 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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