Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
16 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
2000
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: ABBVIE CALL CENTER
- Telefoonnummer: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Studie Locaties
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Taichung, Taiwan, 40447
- Werving
- China Medical University Hospital /ID# 280630
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Alabama
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Dothan, Alabama, Verenigde Staten, 36301
- Werving
- Digestive Health Specialists /ID# 280827
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85018
- Werving
- Elite Clinical Studies /ID# 280477
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Contact:
- Site Coordinator
- Telefoonnummer: 602-788-3437
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Sun City, Arizona, Verenigde Staten, 85351
- Werving
- Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
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California
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Anaheim, California, Verenigde Staten, 92805
- Werving
- Clinnova Research /ID# 280509
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Coronado, California, Verenigde Staten, 92118
- Werving
- Southern California Res. Ctr /ID# 280476
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Lancaster, California, Verenigde Staten, 93534
- Werving
- Gastro Care Institute /ID# 281071
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Los Alamitos, California, Verenigde Staten, 90720
- Werving
- United Medical Doctors - Los Alamitos /ID# 281125
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Rialto, California, Verenigde Staten, 92377
- Werving
- Inland Empire Liver Foundation - Rialto /ID# 280775
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80907
- Werving
- Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
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Florida
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Kissimmee, Florida, Verenigde Staten, 34741
- Werving
- Clinical Research of Osceola /ID# 280593
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Miami, Florida, Verenigde Staten, 33134
- Werving
- Research Associates of South Florida /ID# 280929
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Contact:
- Site Coordinator
- Telefoonnummer: 786-476-8790
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New Port Richey, Florida, Verenigde Staten, 34653
- Werving
- Advanced Research Institute, Inc /ID# 281062
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Contact:
- Site Coordinator
- Telefoonnummer: 727-835-3261
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Orlando, Florida, Verenigde Staten, 32825
- Werving
- Digestive And Liver Center Of Florida - Orlando /ID# 280924
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Georgia
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Macon, Georgia, Verenigde Staten, 31201
- Werving
- Gastroenterology Associates of Central Georgia /ID# 280464
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Roswell, Georgia, Verenigde Staten, 30076
- Werving
- Gastroenterology Consultants - Roswell /ID# 281235
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Contact:
- Site Coordinator
- Telefoonnummer: 404-596-4480
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Idaho
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Boise, Idaho, Verenigde Staten, 83706
- Werving
- Treasure Valley Medical Research /ID# 281778
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Illinois
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Gurnee, Illinois, Verenigde Staten, 60031
- Werving
- Illinois Gastroenterology Group /ID# 283933
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Contact:
- Site Coordinator
- Telefoonnummer: 224-441-2217
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Oak Lawn, Illinois, Verenigde Staten, 60453
- Werving
- Southwest Gastroenterology - Oak Lawn /ID# 280841
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Kentucky
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Louisville, Kentucky, Verenigde Staten, 40218
- Werving
- Gastroenterology Health Partners /ID# 284144
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Louisiana
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Shreveport, Louisiana, Verenigde Staten, 71103
- Werving
- Willis-Knighton Medical Center /ID# 280572
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Contact:
- Site Coordinator
- Telefoonnummer: 318-212-2863
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Mississippi
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Flowood, Mississippi, Verenigde Staten, 39232
- Werving
- Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967
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Missouri
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St Louis, Missouri, Verenigde Staten, 63141
- Werving
- Specialists In Gastroenterology /ID# 283939
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89128
- Werving
- Vector Clinical Trials /ID# 280843
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New York
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New York, New York, Verenigde Staten, 10075
- Werving
- New York Gastroenterology Associates - Upper East Side /ID# 281767
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Ohio
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Englewood, Ohio, Verenigde Staten, 45415
- Werving
- Dayton Gastroenterology - Englewood /ID# 284065
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Westlake, Ohio, Verenigde Staten, 44145
- Werving
- Gastro Intestinal Research Institute of Northern Ohio /ID# 283860
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02905
- Werving
- University Gastroenterology - Providence - Staniford Street /ID# 280919
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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38104
- Werving
- Gastro One - Memphis /ID# 283948
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Texas
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Bellaire, Texas, Verenigde Staten, 77401
- Werving
- Novel Research - Bellaire /ID# 280925
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Georgetown, Texas, Verenigde Staten, 78628
- Werving
- Amel Med /ID# 283864
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Houston, Texas, Verenigde Staten, 77090
- Werving
- Integrity Advanced Therapeutics /ID# 283871
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San Antonio, Texas, Verenigde Staten, 78229
- Werving
- Southern Star Research Institute /ID# 280822
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Washington
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Bellevue, Washington, Verenigde Staten, 98004
- Werving
- Washington Gastroenterology - Bellevue /ID# 283966
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Tacoma, Washington, Verenigde Staten, 98405
- Werving
- Washington Gastroenterology - Tacoma /ID# 284143
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Vancouver, Washington, Verenigde Staten, 98664
- Werving
- The Vancouver Clinic /ID# 280497
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Contact:
- Site Coordinator
- Telefoonnummer: 360-397-3388
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
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Experimenteel: 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.
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Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
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Experimenteel: 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.
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Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
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Experimenteel: 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.
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Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
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Experimenteel: 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.
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Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
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Experimenteel: 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.
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Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
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Experimenteel: 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
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
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Experimenteel: 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
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
|
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Experimenteel: 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
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
|
|
Experimenteel: 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
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
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Experimenteel: 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.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
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Experimenteel: 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.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
|
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Experimenteel: 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.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
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Experimenteel: 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.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
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Experimenteel: 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.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
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Experimenteel: 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.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
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Experimenteel: 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.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Experimenteel: 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.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Experimenteel: 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.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Experimenteel: 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.
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Experimenteel: 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
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Experimenteel: 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
|
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andere namen:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: ABBVIE INC., AbbVie
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
31 juli 2026
Primaire voltooiing (Geschat)
1 oktober 2031
Studie voltooiing (Geschat)
1 oktober 2031
Studieregistratiedata
Eerst ingediend
7 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
7 juli 2026
Eerst geplaatst (Werkelijk)
13 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 september 2026
Laatste update ingediend die voldeed aan QC-criteria
16 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- M26-266
- 2026-525960-16-00 (Andere identificatie: EU CT)
- 2026-525959-86-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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-tijdsbestek voor delen
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD-toegangscriteria voor delen
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .