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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: ABBVIE CALL CENTER
- Puhelinnumero: 844-663-3742
- Sähköposti: abbvieclinicaltrials@abbvie.com
Opiskelupaikat
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Southern District
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Ashdod, Southern District, Israel, 7747600
- Rekrytointi
- Assuta Ashdod Medical Center /ID# 280535
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Hiroshima
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Kure, Hiroshima, Japani, 737-0811
- Rekrytointi
- Kure Kyosai Hospital /ID# 282006
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Québec, Kanada, G1V 4T3
- Rekrytointi
- Diex Recherche Quebec Inc. /ID# 282307
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Kaohsiung City, Taiwan, 807
- Rekrytointi
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 280640
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Taichung, Taiwan, 40447
- Rekrytointi
- China Medical University Hospital /ID# 280630
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Alabama
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Dothan, Alabama, Yhdysvallat, 36301
- Rekrytointi
- Digestive Health Specialists /ID# 280827
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Arizona
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Phoenix, Arizona, Yhdysvallat, 85018
- Rekrytointi
- Elite Clinical Studies /ID# 280477
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Ottaa yhteyttä:
- Site Coordinator
- Puhelinnumero: 602-788-3437
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Sun City, Arizona, Yhdysvallat, 85351
- Rekrytointi
- Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
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California
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Anaheim, California, Yhdysvallat, 92805
- Rekrytointi
- Clinnova Research /ID# 280509
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Coronado, California, Yhdysvallat, 92118
- Rekrytointi
- Southern California Res. Ctr /ID# 280476
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Lancaster, California, Yhdysvallat, 93534
- Rekrytointi
- Gastro Care Institute /ID# 281071
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Los Alamitos, California, Yhdysvallat, 90720
- Rekrytointi
- United Medical Doctors - Los Alamitos /ID# 281125
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Rialto, California, Yhdysvallat, 92377
- Rekrytointi
- Inland Empire Liver Foundation - Rialto /ID# 280775
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Colorado
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Colorado Springs, Colorado, Yhdysvallat, 80907
- Rekrytointi
- Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
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Florida
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Bradenton, Florida, Yhdysvallat, 34209
- Rekrytointi
- Synergy Healthcare - Bradenton /ID# 284157
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Kissimmee, Florida, Yhdysvallat, 34741
- Rekrytointi
- Clinical Research of Osceola /ID# 280593
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Largo, Florida, Yhdysvallat, 33777
- Rekrytointi
- Florida Center For Gastroenterology - Largo /ID# 281059
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Miami, Florida, Yhdysvallat, 33134
- Rekrytointi
- Research Associates of South Florida /ID# 280929
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Ottaa yhteyttä:
- Site Coordinator
- Puhelinnumero: 786-476-8790
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New Port Richey, Florida, Yhdysvallat, 34653
- Rekrytointi
- Advanced Research Institute, Inc /ID# 281062
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Ottaa yhteyttä:
- Site Coordinator
- Puhelinnumero: 727-835-3261
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Orlando, Florida, Yhdysvallat, 32825
- Rekrytointi
- Digestive And Liver Center Of Florida - Orlando /ID# 280924
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Tampa, Florida, Yhdysvallat, 33609
- Rekrytointi
- Gcp Clinical Research /ID# 280469
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Georgia
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Macon, Georgia, Yhdysvallat, 31201
- Rekrytointi
- Gastroenterology Associates of Central Georgia /ID# 280464
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Roswell, Georgia, Yhdysvallat, 30076
- Rekrytointi
- Gastroenterology Consultants - Roswell /ID# 281235
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Ottaa yhteyttä:
- Site Coordinator
- Puhelinnumero: 404-596-4480
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Idaho
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Boise, Idaho, Yhdysvallat, 83706
- Rekrytointi
- Treasure Valley Medical Research /ID# 281778
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Illinois
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Des Plaines, Illinois, Yhdysvallat, 60016
- Rekrytointi
- Midwest Digestive Health & Nutrition /ID# 285250
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Glenview, Illinois, Yhdysvallat, 60026
- Rekrytointi
- Gi Alliance - Glenview /ID# 283932
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Gurnee, Illinois, Yhdysvallat, 60031
- Rekrytointi
- Illinois Gastroenterology Group /ID# 283933
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Ottaa yhteyttä:
- Site Coordinator
- Puhelinnumero: 224-441-2217
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Oak Lawn, Illinois, Yhdysvallat, 60453
- Rekrytointi
- Southwest Gastroenterology - Oak Lawn /ID# 280841
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Indiana
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New Albany, Indiana, Yhdysvallat, 47150
- Rekrytointi
- Gastroenterology Health Partners /ID# 284145
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Kentucky
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Louisville, Kentucky, Yhdysvallat, 40218
- Rekrytointi
- Gastroenterology Health Partners /ID# 284144
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Louisiana
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Mandeville, Louisiana, Yhdysvallat, 70471
- Rekrytointi
- Gastro Group and Endocenter: Mandeville, la /ID# 284186
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Metairie, Louisiana, Yhdysvallat, 70006
- Rekrytointi
- Metropolitan Gastroenterology Associates - Metairie /ID# 283922
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Shreveport, Louisiana, Yhdysvallat, 71103
- Rekrytointi
- Willis-Knighton Medical Center /ID# 280572
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Ottaa yhteyttä:
- Site Coordinator
- Puhelinnumero: 318-212-2863
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Massachusetts
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New Bedford, Massachusetts, Yhdysvallat, 02740
- Rekrytointi
- Lucida Clinical Trials /ID# 282000
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Michigan
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Wyoming, Michigan, Yhdysvallat, 49519
- Rekrytointi
- West Michigan Clinical Research Center /ID# 280480
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Mississippi
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Flowood, Mississippi, Yhdysvallat, 39232
- Rekrytointi
- Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967
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Oxford, Mississippi, Yhdysvallat, 38655
- Rekrytointi
- Gastroenterology Associates Of North Mississippi /ID# 285243
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Missouri
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St Louis, Missouri, Yhdysvallat, 63141
- Rekrytointi
- Specialists In Gastroenterology /ID# 283939
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Nevada
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Las Vegas, Nevada, Yhdysvallat, 89128
- Rekrytointi
- Vector Clinical Trials /ID# 280843
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New York
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New York, New York, Yhdysvallat, 10075
- Rekrytointi
- New York Gastroenterology Associates - Upper East Side /ID# 281767
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North Carolina
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Asheville, North Carolina, Yhdysvallat, 28803
- Rekrytointi
- Digestive Health Partners /ID# 280490
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Ottaa yhteyttä:
- Site Coordinator
- Puhelinnumero: (828) 254-0881
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Ohio
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Beavercreek, Ohio, Yhdysvallat, 45440
- Rekrytointi
- Dayton Gastroenterology - Beavercreek /ID# 284065
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Westlake, Ohio, Yhdysvallat, 44145
- Rekrytointi
- Gastro Intestinal Research Institute of Northern Ohio /ID# 283860
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Rhode Island
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Providence, Rhode Island, Yhdysvallat, 02905
- Rekrytointi
- University Gastroenterology - Providence - Staniford Street /ID# 280919
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South Carolina
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Greenville, South Carolina, Yhdysvallat, 29607
- Rekrytointi
- Gastroenterology Associates - Patewood /ID# 283870
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Tennessee
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Knoxville, Tennessee, Yhdysvallat, 37909
- Rekrytointi
- Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 283861
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Memphis, Tennessee, Yhdysvallat, 38104
- Rekrytointi
- Gastro One - Memphis /ID# 283948
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Texas
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Bellaire, Texas, Yhdysvallat, 77401
- Rekrytointi
- Novel Research - Bellaire /ID# 280925
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Fort Worth, Texas, Yhdysvallat, 76104
- Rekrytointi
- Gi Alliance - Texas Digestive Disease Consultants - Fort Worth /ID# 283977
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Garland, Texas, Yhdysvallat, 75044
- Rekrytointi
- GI Alliance -Garland /ID# 284253
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Ottaa yhteyttä:
- Site Coordinator
- Puhelinnumero: 972-265-8201
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Georgetown, Texas, Yhdysvallat, 78628
- Rekrytointi
- Amel Med /ID# 283864
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Houston, Texas, Yhdysvallat, 77090
- Rekrytointi
- Integrity Advanced Therapeutics /ID# 283871
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Lubbock, Texas, Yhdysvallat, 74910
- Rekrytointi
- GI Alliance - Lubbock /ID# 283920
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Lubbock, Texas, Yhdysvallat, 79424
- Rekrytointi
- Caprock Gastro Research - Lubbock /ID# 283921
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Mansfield, Texas, Yhdysvallat, 76063
- Rekrytointi
- GI Alliance - Mansfield /ID# 283924
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San Antonio, Texas, Yhdysvallat, 78229
- Rekrytointi
- Southern Star Research Institute /ID# 280822
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Shenandoah, Texas, Yhdysvallat, 77384
- Rekrytointi
- Center for Digestive Disease /ID# 280870
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Ottaa yhteyttä:
- Site Coordinator
- Puhelinnumero: 832-234-1023
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Southlake, Texas, Yhdysvallat, 76092
- Rekrytointi
- Texas Digestive Disease Consultants - Southlake /ID# 283931
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Ottaa yhteyttä:
- Site Coordinator
- Puhelinnumero: 817-424-1525
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Tyler, Texas, Yhdysvallat, 75701
- Rekrytointi
- Tyler Research Institute /ID# 284247
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Ottaa yhteyttä:
- Site Coordinator
- Puhelinnumero: 903-630-6211
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Webster, Texas, Yhdysvallat, 77598
- Rekrytointi
- Texas Digestive Disease Consultants /ID# 284245
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Virginia
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Lansdowne Town Center, Virginia, Yhdysvallat, 20176
- Rekrytointi
- Emeritas Research Group /ID# 284388
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Richmond, Virginia, Yhdysvallat, 23229
- Rekrytointi
- GI Alliance - Richmond /ID# 284244
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Washington
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Bellevue, Washington, Yhdysvallat, 98004
- Rekrytointi
- Washington Gastroenterology - Bellevue /ID# 283966
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Tacoma, Washington, Yhdysvallat, 98405
- Rekrytointi
- Washington Gastroenterology - Tacoma /ID# 284143
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Vancouver, Washington, Yhdysvallat, 98664
- Rekrytointi
- The Vancouver Clinic /ID# 280497
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Ottaa yhteyttä:
- Site Coordinator
- Puhelinnumero: 360-397-3388
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Wisconsin
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Milwaukee, Wisconsin, Yhdysvallat, 53215
- Rekrytointi
- Wisconsin Center for Advanced Research /ID# 284250
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
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
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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
|
|
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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
|
|
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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
|
|
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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
|
|
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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
|
|
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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
|
|
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 |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
|
|
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 |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
|
|
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 |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
|
|
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 |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
|
|
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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
|
|
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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
|
|
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. |
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. |
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. |
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. |
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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
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. |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
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 |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
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 |
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Muut nimet:
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
Sponsori
Tutkijat
- Opintojohtaja: ABBVIE INC., AbbVie
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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)?
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
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
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