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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

keskiviikko 16. syyskuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

2000

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Kokeellinen: 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.
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Kokeellinen: 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.
Lääke: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-382
Kokeellinen: 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.
Lääke: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-382
Kokeellinen: 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.
Lääke: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-382
Kokeellinen: 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.
Lääke: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-382
Kokeellinen: 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
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Lääke: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-382
Kokeellinen: 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
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Lääke: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-382
Kokeellinen: 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
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Lääke: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-382
Kokeellinen: 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
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Lääke: Trosunilimab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-382
Kokeellinen: 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.
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Kokeellinen: 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.
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Kokeellinen: 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.
Lääke: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kokeellinen: 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.
Lääke: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kokeellinen: 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.
Lääke: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kokeellinen: 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.
Lääke: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kokeellinen: 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.
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Lääke: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kokeellinen: 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.
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Lääke: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kokeellinen: 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.
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Lääke: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kokeellinen: 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.
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Lääke: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kokeellinen: 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
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Lääke: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Kokeellinen: 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
Lääke: Risankizumab
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
  • ABBV-066
Lääke: ABBV-701
Intravenous/Subcutaneous/Intramuscular Injection/Infusion

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

AbbVie

Tutkijat

  • Opintojohtaja: ABBVIE INC., AbbVie

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Perjantai 31. heinäkuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Keskiviikko 1. lokakuuta 2031

Opintojen valmistuminen (Arvioitu)

Keskiviikko 1. lokakuuta 2031

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 7. heinäkuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 7. heinäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Maanantai 13. heinäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 18. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 16. syyskuuta 2026

Viimeksi vahvistettu

Tiistai 1. syyskuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

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IPD-suunnitelman kuvaus

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-jaon aikakehys

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

IPD-jaon käyttöoikeuskriteerit

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

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

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Yhdysvalloissa valmistettu ja sieltä viety tuote

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