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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. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

2000

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Experimentální: 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.
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Experimentální: 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.
Lék: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-382
Experimentální: 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.
Lék: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-382
Experimentální: 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.
Lék: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-382
Experimentální: 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.
Lék: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-382
Experimentální: 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
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Lék: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-382
Experimentální: 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
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Lék: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-382
Experimentální: 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
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Lék: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-382
Experimentální: 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
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Lék: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-382
Experimentální: 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.
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Experimentální: 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.
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Experimentální: 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.
Lék: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimentální: 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.
Lék: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimentální: 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.
Lék: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimentální: 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.
Lék: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimentální: 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.
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Lék: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimentální: 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.
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Lék: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimentální: 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.
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Lék: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimentální: 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.
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Lék: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimentální: 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
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Lék: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Experimentální: 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
Lék: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Ostatní jména:
  • ABBV-066
Lék: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Časové okno: 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
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

AbbVie

Vyšetřovatelé

  • Ředitel studie: ABBVIE INC., AbbVie

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

24. července 2026

Primární dokončení (Odhadovaný)

1. října 2031

Dokončení studie (Odhadovaný)

1. října 2031

Termíny zápisu do studia

První předloženo

7. července 2026

První předloženo, které splnilo kritéria kontroly kvality

7. července 2026

První zveřejněno (Aktuální)

13. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení IPD

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

Kritéria přístupu pro sdílení IPD

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

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Klinické studie na Risankizumab

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Gambia

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
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