Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
16. september 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
2000
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-post: abbvieclinicaltrials@abbvie.com
Studiesteder
-
-
Alabama
-
Dothan, Alabama, Forente stater, 36301
- Rekruttering
- Digestive Health Specialists /ID# 280827
-
-
Arizona
-
Phoenix, Arizona, Forente stater, 85018
- Rekruttering
- Elite Clinical Studies /ID# 280477
-
Ta kontakt med:
- Site Coordinator
- Telefonnummer: 602-788-3437
-
Sun City, Arizona, Forente stater, 85351
- Rekruttering
- Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
-
-
California
-
Anaheim, California, Forente stater, 92805
- Rekruttering
- Clinnova Research /ID# 280509
-
Coronado, California, Forente stater, 92118
- Rekruttering
- Southern California Res. Ctr /ID# 280476
-
Lancaster, California, Forente stater, 93534
- Rekruttering
- Gastro Care Institute /ID# 281071
-
Los Alamitos, California, Forente stater, 90720
- Rekruttering
- United Medical Doctors - Los Alamitos /ID# 281125
-
Rialto, California, Forente stater, 92377
- Rekruttering
- Inland Empire Liver Foundation - Rialto /ID# 280775
-
-
Colorado
-
Colorado Springs, Colorado, Forente stater, 80907
- Rekruttering
- Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
-
-
Florida
-
Kissimmee, Florida, Forente stater, 34741
- Rekruttering
- Clinical Research of Osceola /ID# 280593
-
Miami, Florida, Forente stater, 33134
- Rekruttering
- Research Associates of South Florida /ID# 280929
-
Ta kontakt med:
- Site Coordinator
- Telefonnummer: 786-476-8790
-
New Port Richey, Florida, Forente stater, 34653
- Rekruttering
- Advanced Research Institute, Inc /ID# 281062
-
Ta kontakt med:
- Site Coordinator
- Telefonnummer: 727-835-3261
-
Orlando, Florida, Forente stater, 32825
- Rekruttering
- Digestive And Liver Center Of Florida - Orlando /ID# 280924
-
-
Georgia
-
Macon, Georgia, Forente stater, 31201
- Rekruttering
- Gastroenterology Associates of Central Georgia /ID# 280464
-
Roswell, Georgia, Forente stater, 30076
- Rekruttering
- Gastroenterology Consultants - Roswell /ID# 281235
-
Ta kontakt med:
- Site Coordinator
- Telefonnummer: 404-596-4480
-
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Idaho
-
Boise, Idaho, Forente stater, 83706
- Rekruttering
- Treasure Valley Medical Research /ID# 281778
-
-
Illinois
-
Gurnee, Illinois, Forente stater, 60031
- Rekruttering
- Illinois Gastroenterology Group /ID# 283933
-
Ta kontakt med:
- Site Coordinator
- Telefonnummer: 224-441-2217
-
Oak Lawn, Illinois, Forente stater, 60453
- Rekruttering
- Southwest Gastroenterology - Oak Lawn /ID# 280841
-
-
Kentucky
-
Louisville, Kentucky, Forente stater, 40218
- Rekruttering
- Gastroenterology Health Partners /ID# 284144
-
-
Louisiana
-
Shreveport, Louisiana, Forente stater, 71103
- Rekruttering
- Willis-Knighton Medical Center /ID# 280572
-
Ta kontakt med:
- Site Coordinator
- Telefonnummer: 318-212-2863
-
-
Mississippi
-
Flowood, Mississippi, Forente stater, 39232
- Rekruttering
- Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967
-
-
Missouri
-
St Louis, Missouri, Forente stater, 63141
- Rekruttering
- Specialists In Gastroenterology /ID# 283939
-
-
Nevada
-
Las Vegas, Nevada, Forente stater, 89128
- Rekruttering
- Vector Clinical Trials /ID# 280843
-
-
New York
-
New York, New York, Forente stater, 10075
- Rekruttering
- New York Gastroenterology Associates - Upper East Side /ID# 281767
-
-
Ohio
-
Englewood, Ohio, Forente stater, 45415
- Rekruttering
- Dayton Gastroenterology - Englewood /ID# 284065
-
Westlake, Ohio, Forente stater, 44145
- Rekruttering
- Gastro Intestinal Research Institute of Northern Ohio /ID# 283860
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02905
- Rekruttering
- University Gastroenterology - Providence - Staniford Street /ID# 280919
-
-
Tennessee
-
Memphis, Tennessee, Forente stater, 38104
- Rekruttering
- Gastro One - Memphis /ID# 283948
-
-
Texas
-
Bellaire, Texas, Forente stater, 77401
- Rekruttering
- Novel Research - Bellaire /ID# 280925
-
Georgetown, Texas, Forente stater, 78628
- Rekruttering
- Amel Med /ID# 283864
-
Houston, Texas, Forente stater, 77090
- Rekruttering
- Integrity Advanced Therapeutics /ID# 283871
-
San Antonio, Texas, Forente stater, 78229
- Rekruttering
- Southern Star Research Institute /ID# 280822
-
-
Washington
-
Bellevue, Washington, Forente stater, 98004
- Rekruttering
- Washington Gastroenterology - Bellevue /ID# 283966
-
Tacoma, Washington, Forente stater, 98405
- Rekruttering
- Washington Gastroenterology - Tacoma /ID# 284143
-
Vancouver, Washington, Forente stater, 98664
- Rekruttering
- The Vancouver Clinic /ID# 280497
-
Ta kontakt med:
- Site Coordinator
- Telefonnummer: 360-397-3388
-
-
-
-
-
Taichung, Taiwan, 40447
- Rekruttering
- China Medical University Hospital /ID# 280630
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
|
|
Eksperimentell: 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 navn:
|
|
Eksperimentell: 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 navn:
|
|
Eksperimentell: 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 navn:
|
|
Eksperimentell: 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 navn:
|
|
Eksperimentell: 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 navn:
|
|
Eksperimentell: 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 navn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navn:
|
|
Eksperimentell: 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 navn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navn:
|
|
Eksperimentell: 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 navn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navn:
|
|
Eksperimentell: 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 navn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andre navn:
|
|
Eksperimentell: 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 navn:
|
|
Eksperimentell: 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 navn:
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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 navn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Eksperimentell: 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 navn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Eksperimentell: 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 navn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Eksperimentell: 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 navn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Eksperimentell: 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 navn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Eksperimentell: 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 navn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: ABBVIE INC., AbbVie
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
31. juli 2026
Primær fullføring (Antatt)
1. oktober 2031
Studiet fullført (Antatt)
1. oktober 2031
Datoer for studieregistrering
Først innsendt
7. juli 2026
Først innsendt som oppfylte QC-kriteriene
7. juli 2026
Først lagt ut (Faktiske)
13. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- M26-266
- 2026-525960-16-00 (Annen identifikator: EU CT)
- 2026-525959-86-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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/
Tilgangskriterier for IPD-deling
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .