Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
16. september 2026 opdateret af: 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.
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
2000
Fase
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Studiesteder
-
-
Alabama
-
Dothan, Alabama, Forenede Stater, 36301
- Rekruttering
- Digestive Health Specialists /ID# 280827
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85018
- Rekruttering
- Elite Clinical Studies /ID# 280477
-
Kontakt:
- Site Coordinator
- Telefonnummer: 602-788-3437
-
Sun City, Arizona, Forenede Stater, 85351
- Rekruttering
- Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
-
-
California
-
Anaheim, California, Forenede Stater, 92805
- Rekruttering
- Clinnova Research /ID# 280509
-
Coronado, California, Forenede Stater, 92118
- Rekruttering
- Southern California Res. Ctr /ID# 280476
-
Lancaster, California, Forenede Stater, 93534
- Rekruttering
- Gastro Care Institute /ID# 281071
-
Los Alamitos, California, Forenede Stater, 90720
- Rekruttering
- United Medical Doctors - Los Alamitos /ID# 281125
-
Rialto, California, Forenede Stater, 92377
- Rekruttering
- Inland Empire Liver Foundation - Rialto /ID# 280775
-
-
Colorado
-
Colorado Springs, Colorado, Forenede Stater, 80907
- Rekruttering
- Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
-
-
Florida
-
Kissimmee, Florida, Forenede Stater, 34741
- Rekruttering
- Clinical Research of Osceola /ID# 280593
-
Miami, Florida, Forenede Stater, 33134
- Rekruttering
- Research Associates of South Florida /ID# 280929
-
Kontakt:
- Site Coordinator
- Telefonnummer: 786-476-8790
-
New Port Richey, Florida, Forenede Stater, 34653
- Rekruttering
- Advanced Research Institute, Inc /ID# 281062
-
Kontakt:
- Site Coordinator
- Telefonnummer: 727-835-3261
-
Orlando, Florida, Forenede Stater, 32825
- Rekruttering
- Digestive And Liver Center Of Florida - Orlando /ID# 280924
-
-
Georgia
-
Macon, Georgia, Forenede Stater, 31201
- Rekruttering
- Gastroenterology Associates of Central Georgia /ID# 280464
-
Roswell, Georgia, Forenede Stater, 30076
- Rekruttering
- Gastroenterology Consultants - Roswell /ID# 281235
-
Kontakt:
- Site Coordinator
- Telefonnummer: 404-596-4480
-
-
Idaho
-
Boise, Idaho, Forenede Stater, 83706
- Rekruttering
- Treasure Valley Medical Research /ID# 281778
-
-
Illinois
-
Gurnee, Illinois, Forenede Stater, 60031
- Rekruttering
- Illinois Gastroenterology Group /ID# 283933
-
Kontakt:
- Site Coordinator
- Telefonnummer: 224-441-2217
-
Oak Lawn, Illinois, Forenede Stater, 60453
- Rekruttering
- Southwest Gastroenterology - Oak Lawn /ID# 280841
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40218
- Rekruttering
- Gastroenterology Health Partners /ID# 284144
-
-
Louisiana
-
Shreveport, Louisiana, Forenede Stater, 71103
- Rekruttering
- Willis-Knighton Medical Center /ID# 280572
-
Kontakt:
- Site Coordinator
- Telefonnummer: 318-212-2863
-
-
Mississippi
-
Flowood, Mississippi, Forenede Stater, 39232
- Rekruttering
- Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967
-
-
Missouri
-
St Louis, Missouri, Forenede Stater, 63141
- Rekruttering
- Specialists In Gastroenterology /ID# 283939
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89128
- Rekruttering
- Vector Clinical Trials /ID# 280843
-
-
New York
-
New York, New York, Forenede Stater, 10075
- Rekruttering
- New York Gastroenterology Associates - Upper East Side /ID# 281767
-
-
Ohio
-
Englewood, Ohio, Forenede Stater, 45415
- Rekruttering
- Dayton Gastroenterology - Englewood /ID# 284065
-
Westlake, Ohio, Forenede Stater, 44145
- Rekruttering
- Gastro Intestinal Research Institute of Northern Ohio /ID# 283860
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02905
- Rekruttering
- University Gastroenterology - Providence - Staniford Street /ID# 280919
-
-
Tennessee
-
Memphis, Tennessee, Forenede Stater, 38104
- Rekruttering
- Gastro One - Memphis /ID# 283948
-
-
Texas
-
Bellaire, Texas, Forenede Stater, 77401
- Rekruttering
- Novel Research - Bellaire /ID# 280925
-
Georgetown, Texas, Forenede Stater, 78628
- Rekruttering
- Amel Med /ID# 283864
-
Houston, Texas, Forenede Stater, 77090
- Rekruttering
- Integrity Advanced Therapeutics /ID# 283871
-
San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- Southern Star Research Institute /ID# 280822
-
-
Washington
-
Bellevue, Washington, Forenede Stater, 98004
- Rekruttering
- Washington Gastroenterology - Bellevue /ID# 283966
-
Tacoma, Washington, Forenede Stater, 98405
- Rekruttering
- Washington Gastroenterology - Tacoma /ID# 284143
-
Vancouver, Washington, Forenede Stater, 98664
- Rekruttering
- The Vancouver Clinic /ID# 280497
-
Kontakt:
- Site Coordinator
- Telefonnummer: 360-397-3388
-
-
-
-
-
Taichung, Taiwan, 40447
- Rekruttering
- China Medical University Hospital /ID# 280630
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
22
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
Andre navne:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Eksperimentel: 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
Andre navne:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Eksperimentel: 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
Andre navne:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Eksperimentel: 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
Andre navne:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Eksperimentel: 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
Andre navne:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Eksperimentel: 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
Andre navne:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: ABBVIE INC., AbbVie
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
31. juli 2026
Primær færdiggørelse (Anslået)
Primær færdiggørelse
1. oktober 2031
Studieafslutning (Anslået)
Studieafslutning
1. oktober 2031
Datoer for studieregistrering
Først indsendt
Først indsendt
7. juli 2026
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
7. juli 2026
Først opslået (Faktiske)
Først opslået
13. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. september 2026
Sidst verificeret
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- M26-266
- 2026-525960-16-00 (Anden identifikator: EU CT)
- 2026-525959-86-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD-delingsadgangskriterier
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .