Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ABBVIE CALL CENTER
- Número de teléfono: 844-663-3742
- Correo electrónico: abbvieclinicaltrials@abbvie.com
Ubicaciones de estudio
-
-
-
Québec, Canadá, G1V 4T3
- Reclutamiento
- Diex Recherche Quebec Inc. /ID# 282307
-
-
-
-
Alabama
-
Dothan, Alabama, Estados Unidos, 36301
- Reclutamiento
- Digestive Health Specialists /ID# 280827
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85018
- Reclutamiento
- Elite Clinical Studies /ID# 280477
-
Contacto:
- Site Coordinator
- Número de teléfono: 602-788-3437
-
Sun City, Arizona, Estados Unidos, 85351
- Reclutamiento
- Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
-
-
California
-
Anaheim, California, Estados Unidos, 92805
- Reclutamiento
- Clinnova Research /ID# 280509
-
Coronado, California, Estados Unidos, 92118
- Reclutamiento
- Southern California Res. Ctr /ID# 280476
-
Lancaster, California, Estados Unidos, 93534
- Reclutamiento
- Gastro Care Institute /ID# 281071
-
Los Alamitos, California, Estados Unidos, 90720
- Reclutamiento
- United Medical Doctors - Los Alamitos /ID# 281125
-
Rialto, California, Estados Unidos, 92377
- Reclutamiento
- Inland Empire Liver Foundation - Rialto /ID# 280775
-
-
Colorado
-
Colorado Springs, Colorado, Estados Unidos, 80907
- Reclutamiento
- Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
-
-
Florida
-
Bradenton, Florida, Estados Unidos, 34209
- Reclutamiento
- Synergy Healthcare - Bradenton /ID# 284157
-
Kissimmee, Florida, Estados Unidos, 34741
- Reclutamiento
- Clinical Research of Osceola /ID# 280593
-
Largo, Florida, Estados Unidos, 33777
- Reclutamiento
- Florida Center For Gastroenterology - Largo /ID# 281059
-
Miami, Florida, Estados Unidos, 33134
- Reclutamiento
- Research Associates of South Florida /ID# 280929
-
Contacto:
- Site Coordinator
- Número de teléfono: 786-476-8790
-
New Port Richey, Florida, Estados Unidos, 34653
- Reclutamiento
- Advanced Research Institute, Inc /ID# 281062
-
Contacto:
- Site Coordinator
- Número de teléfono: 727-835-3261
-
Orlando, Florida, Estados Unidos, 32825
- Reclutamiento
- Digestive And Liver Center Of Florida - Orlando /ID# 280924
-
Tampa, Florida, Estados Unidos, 33609
- Reclutamiento
- Gcp Clinical Research /ID# 280469
-
-
Georgia
-
Macon, Georgia, Estados Unidos, 31201
- Reclutamiento
- Gastroenterology Associates of Central Georgia /ID# 280464
-
Roswell, Georgia, Estados Unidos, 30076
- Reclutamiento
- Gastroenterology Consultants - Roswell /ID# 281235
-
Contacto:
- Site Coordinator
- Número de teléfono: 404-596-4480
-
-
Idaho
-
Boise, Idaho, Estados Unidos, 83706
- Reclutamiento
- Treasure Valley Medical Research /ID# 281778
-
-
Illinois
-
Des Plaines, Illinois, Estados Unidos, 60016
- Reclutamiento
- Midwest Digestive Health & Nutrition /ID# 285250
-
Glenview, Illinois, Estados Unidos, 60026
- Reclutamiento
- Gi Alliance - Glenview /ID# 283932
-
Gurnee, Illinois, Estados Unidos, 60031
- Reclutamiento
- Illinois Gastroenterology Group /ID# 283933
-
Contacto:
- Site Coordinator
- Número de teléfono: 224-441-2217
-
Oak Lawn, Illinois, Estados Unidos, 60453
- Reclutamiento
- Southwest Gastroenterology - Oak Lawn /ID# 280841
-
-
Indiana
-
New Albany, Indiana, Estados Unidos, 47150
- Reclutamiento
- Gastroenterology Health Partners /ID# 284145
-
-
Kentucky
-
Louisville, Kentucky, Estados Unidos, 40218
- Reclutamiento
- Gastroenterology Health Partners /ID# 284144
-
-
Louisiana
-
Mandeville, Louisiana, Estados Unidos, 70471
- Reclutamiento
- Gastro Group and Endocenter: Mandeville, la /ID# 284186
-
Metairie, Louisiana, Estados Unidos, 70006
- Reclutamiento
- Metropolitan Gastroenterology Associates - Metairie /ID# 283922
-
Shreveport, Louisiana, Estados Unidos, 71103
- Reclutamiento
- Willis-Knighton Medical Center /ID# 280572
-
Contacto:
- Site Coordinator
- Número de teléfono: 318-212-2863
-
-
Massachusetts
-
New Bedford, Massachusetts, Estados Unidos, 02740
- Reclutamiento
- Lucida Clinical Trials /ID# 282000
-
-
Michigan
-
Wyoming, Michigan, Estados Unidos, 49519
- Reclutamiento
- West Michigan Clinical Research Center /ID# 280480
-
-
Mississippi
-
Flowood, Mississippi, Estados Unidos, 39232
- Reclutamiento
- Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967
-
Oxford, Mississippi, Estados Unidos, 38655
- Reclutamiento
- Gastroenterology Associates Of North Mississippi /ID# 285243
-
-
Missouri
-
St Louis, Missouri, Estados Unidos, 63141
- Reclutamiento
- Specialists In Gastroenterology /ID# 283939
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89128
- Reclutamiento
- Vector Clinical Trials /ID# 280843
-
-
New York
-
New York, New York, Estados Unidos, 10075
- Reclutamiento
- New York Gastroenterology Associates - Upper East Side /ID# 281767
-
-
North Carolina
-
Asheville, North Carolina, Estados Unidos, 28803
- Reclutamiento
- Digestive Health Partners /ID# 280490
-
Contacto:
- Site Coordinator
- Número de teléfono: (828) 254-0881
-
-
Ohio
-
Beavercreek, Ohio, Estados Unidos, 45440
- Reclutamiento
- Dayton Gastroenterology - Beavercreek /ID# 284065
-
Westlake, Ohio, Estados Unidos, 44145
- Reclutamiento
- Gastro Intestinal Research Institute of Northern Ohio /ID# 283860
-
-
Rhode Island
-
Providence, Rhode Island, Estados Unidos, 02905
- Reclutamiento
- University Gastroenterology - Providence - Staniford Street /ID# 280919
-
-
South Carolina
-
Greenville, South Carolina, Estados Unidos, 29607
- Reclutamiento
- Gastroenterology Associates - Patewood /ID# 283870
-
-
Tennessee
-
Knoxville, Tennessee, Estados Unidos, 37909
- Reclutamiento
- Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 283861
-
Memphis, Tennessee, Estados Unidos, 38104
- Reclutamiento
- Gastro One - Memphis /ID# 283948
-
-
Texas
-
Bellaire, Texas, Estados Unidos, 77401
- Reclutamiento
- Novel Research - Bellaire /ID# 280925
-
Fort Worth, Texas, Estados Unidos, 76104
- Reclutamiento
- Gi Alliance - Texas Digestive Disease Consultants - Fort Worth /ID# 283977
-
Garland, Texas, Estados Unidos, 75044
- Reclutamiento
- GI Alliance -Garland /ID# 284253
-
Contacto:
- Site Coordinator
- Número de teléfono: 972-265-8201
-
Georgetown, Texas, Estados Unidos, 78628
- Reclutamiento
- Amel Med /ID# 283864
-
Houston, Texas, Estados Unidos, 77090
- Reclutamiento
- Integrity Advanced Therapeutics /ID# 283871
-
Lubbock, Texas, Estados Unidos, 74910
- Reclutamiento
- GI Alliance - Lubbock /ID# 283920
-
Lubbock, Texas, Estados Unidos, 79424
- Reclutamiento
- Caprock Gastro Research - Lubbock /ID# 283921
-
Mansfield, Texas, Estados Unidos, 76063
- Reclutamiento
- GI Alliance - Mansfield /ID# 283924
-
San Antonio, Texas, Estados Unidos, 78229
- Reclutamiento
- Southern Star Research Institute /ID# 280822
-
Shenandoah, Texas, Estados Unidos, 77384
- Reclutamiento
- Center for Digestive Disease /ID# 280870
-
Contacto:
- Site Coordinator
- Número de teléfono: 832-234-1023
-
Southlake, Texas, Estados Unidos, 76092
- Reclutamiento
- Texas Digestive Disease Consultants - Southlake /ID# 283931
-
Contacto:
- Site Coordinator
- Número de teléfono: 817-424-1525
-
Tyler, Texas, Estados Unidos, 75701
- Reclutamiento
- Tyler Research Institute /ID# 284247
-
Contacto:
- Site Coordinator
- Número de teléfono: 903-630-6211
-
Webster, Texas, Estados Unidos, 77598
- Reclutamiento
- Texas Digestive Disease Consultants /ID# 284245
-
-
Virginia
-
Lansdowne Town Center, Virginia, Estados Unidos, 20176
- Reclutamiento
- Emeritas Research Group /ID# 284388
-
Richmond, Virginia, Estados Unidos, 23229
- Reclutamiento
- GI Alliance - Richmond /ID# 284244
-
-
Washington
-
Bellevue, Washington, Estados Unidos, 98004
- Reclutamiento
- Washington Gastroenterology - Bellevue /ID# 283966
-
Tacoma, Washington, Estados Unidos, 98405
- Reclutamiento
- Washington Gastroenterology - Tacoma /ID# 284143
-
Vancouver, Washington, Estados Unidos, 98664
- Reclutamiento
- The Vancouver Clinic /ID# 280497
-
Contacto:
- Site Coordinator
- Número de teléfono: 360-397-3388
-
-
Wisconsin
-
Milwaukee, Wisconsin, Estados Unidos, 53215
- Reclutamiento
- Wisconsin Center for Advanced Research /ID# 284250
-
-
-
-
Southern District
-
Ashdod, Southern District, Israel, 7747600
- Reclutamiento
- Assuta Ashdod Medical Center /ID# 280535
-
-
-
-
Hiroshima
-
Kure, Hiroshima, Japón, 737-0811
- Reclutamiento
- Kure Kyosai Hospital /ID# 282006
-
-
-
-
-
Kaohsiung City, Taiwán, 807
- Reclutamiento
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 280640
-
Taichung, Taiwán, 40447
- Reclutamiento
- China Medical University Hospital /ID# 280630
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
Otros nombres:
|
|
Experimental: 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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Otros nombres:
|
|
Experimental: 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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Otros nombres:
|
|
Experimental: 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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Otros nombres:
|
|
Experimental: 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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Otros nombres:
|
|
Experimental: 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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Otros nombres:
|
|
Experimental: 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
Otros nombres:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Otros nombres:
|
|
Experimental: 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
Otros nombres:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Otros nombres:
|
|
Experimental: 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
Otros nombres:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Otros nombres:
|
|
Experimental: 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
Otros nombres:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Otros nombres:
|
|
Experimental: 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
Otros nombres:
|
|
Experimental: 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
Otros nombres:
|
|
Experimental: 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 |
|
Experimental: 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 |
|
Experimental: 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 |
|
Experimental: 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 |
|
Experimental: 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
Otros nombres:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion |
|
Experimental: 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
Otros nombres:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion |
|
Experimental: 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
Otros nombres:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion |
|
Experimental: 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
Otros nombres:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion |
|
Experimental: 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
Otros nombres:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion |
|
Experimental: 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
Otros nombres:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: ABBVIE INC., AbbVie
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M26-266
- 2026-525960-16-00 (Otro identificador: EU CT)
- 2026-525959-86-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Criterios de acceso compartido de IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .