Ezt az oldalt automatikusan lefordították, és a fordítás pontossága nem garantált. Kérjük, olvassa el a angol verzió forrásszöveghez.

Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis

2026. szeptember 16. frissítette: 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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

2000

Fázis

  • 2. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Egyesült Államok
    • Alabama
      • Dothan, Alabama, Egyesült Államok, 36301
        • Toborzás
        • Digestive Health Specialists /ID# 280827
    • Arizona
      • Phoenix, Arizona, Egyesült Államok, 85018
        • Toborzás
        • Elite Clinical Studies /ID# 280477
        • Kapcsolatba lépni:
          • Site Coordinator
          • Telefonszám: 602-788-3437
      • Sun City, Arizona, Egyesült Államok, 85351
        • Toborzás
        • Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
    • California
      • Anaheim, California, Egyesült Államok, 92805
        • Toborzás
        • Clinnova Research /ID# 280509
      • Coronado, California, Egyesült Államok, 92118
        • Toborzás
        • Southern California Res. Ctr /ID# 280476
      • Lancaster, California, Egyesült Államok, 93534
        • Toborzás
        • Gastro Care Institute /ID# 281071
      • Los Alamitos, California, Egyesült Államok, 90720
        • Toborzás
        • United Medical Doctors - Los Alamitos /ID# 281125
      • Rialto, California, Egyesült Államok, 92377
        • Toborzás
        • Inland Empire Liver Foundation - Rialto /ID# 280775
    • Colorado
      • Colorado Springs, Colorado, Egyesült Államok, 80907
        • Toborzás
        • Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
    • Florida
      • Kissimmee, Florida, Egyesült Államok, 34741
        • Toborzás
        • Clinical Research of Osceola /ID# 280593
      • Miami, Florida, Egyesült Államok, 33134
        • Toborzás
        • Research Associates of South Florida /ID# 280929
        • Kapcsolatba lépni:
          • Site Coordinator
          • Telefonszám: 786-476-8790
      • New Port Richey, Florida, Egyesült Államok, 34653
        • Toborzás
        • Advanced Research Institute, Inc /ID# 281062
        • Kapcsolatba lépni:
          • Site Coordinator
          • Telefonszám: 727-835-3261
      • Orlando, Florida, Egyesült Államok, 32825
        • Toborzás
        • Digestive And Liver Center Of Florida - Orlando /ID# 280924
    • Georgia
      • Macon, Georgia, Egyesült Államok, 31201
        • Toborzás
        • Gastroenterology Associates of Central Georgia /ID# 280464
      • Roswell, Georgia, Egyesült Államok, 30076
        • Toborzás
        • Gastroenterology Consultants - Roswell /ID# 281235
        • Kapcsolatba lépni:
          • Site Coordinator
          • Telefonszám: 404-596-4480
    • Idaho
      • Boise, Idaho, Egyesült Államok, 83706
        • Toborzás
        • Treasure Valley Medical Research /ID# 281778
    • Illinois
      • Gurnee, Illinois, Egyesült Államok, 60031
        • Toborzás
        • Illinois Gastroenterology Group /ID# 283933
        • Kapcsolatba lépni:
          • Site Coordinator
          • Telefonszám: 224-441-2217
      • Oak Lawn, Illinois, Egyesült Államok, 60453
        • Toborzás
        • Southwest Gastroenterology - Oak Lawn /ID# 280841
    • Kentucky
      • Louisville, Kentucky, Egyesült Államok, 40218
        • Toborzás
        • Gastroenterology Health Partners /ID# 284144
    • Louisiana
      • Shreveport, Louisiana, Egyesült Államok, 71103
        • Toborzás
        • Willis-Knighton Medical Center /ID# 280572
        • Kapcsolatba lépni:
          • Site Coordinator
          • Telefonszám: 318-212-2863
    • Mississippi
      • Flowood, Mississippi, Egyesült Államok, 39232
        • Toborzás
        • Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967
    • Missouri
      • St Louis, Missouri, Egyesült Államok, 63141
        • Toborzás
        • Specialists In Gastroenterology /ID# 283939
    • Nevada
      • Las Vegas, Nevada, Egyesült Államok, 89128
        • Toborzás
        • Vector Clinical Trials /ID# 280843
    • New York
      • New York, New York, Egyesült Államok, 10075
        • Toborzás
        • New York Gastroenterology Associates - Upper East Side /ID# 281767
    • Ohio
      • Englewood, Ohio, Egyesült Államok, 45415
        • Toborzás
        • Dayton Gastroenterology - Englewood /ID# 284065
      • Westlake, Ohio, Egyesült Államok, 44145
        • Toborzás
        • Gastro Intestinal Research Institute of Northern Ohio /ID# 283860
    • Rhode Island
      • Providence, Rhode Island, Egyesült Államok, 02905
        • Toborzás
        • University Gastroenterology - Providence - Staniford Street /ID# 280919
    • Tennessee
      • Memphis, Tennessee, Egyesült Államok, 38104
        • Toborzás
        • Gastro One - Memphis /ID# 283948
    • Texas
      • Bellaire, Texas, Egyesült Államok, 77401
        • Toborzás
        • Novel Research - Bellaire /ID# 280925
      • Georgetown, Texas, Egyesült Államok, 78628
        • Toborzás
        • Amel Med /ID# 283864
      • Houston, Texas, Egyesült Államok, 77090
        • Toborzás
        • Integrity Advanced Therapeutics /ID# 283871
      • San Antonio, Texas, Egyesült Államok, 78229
        • Toborzás
        • Southern Star Research Institute /ID# 280822
    • Washington
      • Bellevue, Washington, Egyesült Államok, 98004
        • Toborzás
        • Washington Gastroenterology - Bellevue /ID# 283966
      • Tacoma, Washington, Egyesült Államok, 98405
        • Toborzás
        • Washington Gastroenterology - Tacoma /ID# 284143
      • Vancouver, Washington, Egyesült Államok, 98664
        • Toborzás
        • The Vancouver Clinic /ID# 280497
        • Kapcsolatba lépni:
          • Site Coordinator
          • Telefonszám: 360-397-3388
  • Tajvan
      • Taichung, Tajvan, 40447
        • Toborzás
        • China Medical University Hospital /ID# 280630

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Kettős

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Kísérleti: 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.
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Kísérleti: 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.
Drog: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-382
Kísérleti: 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.
Drog: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-382
Kísérleti: 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.
Drog: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-382
Kísérleti: 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.
Drog: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-382
Kísérleti: 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
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Drog: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-382
Kísérleti: 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
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Drog: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-382
Kísérleti: 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
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Drog: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-382
Kísérleti: 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
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Drog: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-382
Kísérleti: 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.
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Kísérleti: 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.
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Kísérleti: 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.
Drog: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kísérleti: 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.
Drog: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kísérleti: 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.
Drog: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kísérleti: 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.
Drog: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kísérleti: 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.
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Drog: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kísérleti: 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.
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Drog: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kísérleti: 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.
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Drog: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kísérleti: 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.
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Drog: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kísérleti: 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
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Drog: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kísérleti: 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
Drog: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Más nevek:
  • ABBV-066
Drog: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Időkeret: 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
Időkeret: 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)
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

AbbVie

Nyomozók

  • Tanulmányi igazgató: ABBVIE INC., AbbVie

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. július 31.

Elsődleges befejezés (Becsült)

2031. október 1.

A tanulmány befejezése (Becsült)

2031. október 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. július 7.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 7.

Első közzététel (Tényleges)

2026. július 13.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 18.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 16.

Utolsó ellenőrzés

2026. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

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

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

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 megosztási időkeret

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

IPD-megosztási hozzáférési feltételek

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

Az IPD megosztását támogató információ típusa

  • STUDY_PROTOCOL
  • NEDV

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Igen

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

az Egyesült Államokban gyártott és onnan exportált termék

Igen

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Iratkozz fel