Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis
16 september 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
2000
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-post: abbvieclinicaltrials@abbvie.com
Studieorter
-
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Alabama
-
Dothan, Alabama, Förenta staterna, 36301
- Rekrytering
- Digestive Health Specialists /ID# 280827
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85018
- Rekrytering
- Elite Clinical Studies /ID# 280477
-
Kontakt:
- Site Coordinator
- Telefonnummer: 602-788-3437
-
Sun City, Arizona, Förenta staterna, 85351
- Rekrytering
- Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084
-
-
California
-
Anaheim, California, Förenta staterna, 92805
- Rekrytering
- Clinnova Research /ID# 280509
-
Coronado, California, Förenta staterna, 92118
- Rekrytering
- Southern California Res. Ctr /ID# 280476
-
Lancaster, California, Förenta staterna, 93534
- Rekrytering
- Gastro Care Institute /ID# 281071
-
Los Alamitos, California, Förenta staterna, 90720
- Rekrytering
- United Medical Doctors - Los Alamitos /ID# 281125
-
Rialto, California, Förenta staterna, 92377
- Rekrytering
- Inland Empire Liver Foundation - Rialto /ID# 280775
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80907
- Rekrytering
- Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507
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Florida
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Kissimmee, Florida, Förenta staterna, 34741
- Rekrytering
- Clinical Research of Osceola /ID# 280593
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Miami, Florida, Förenta staterna, 33134
- Rekrytering
- Research Associates of South Florida /ID# 280929
-
Kontakt:
- Site Coordinator
- Telefonnummer: 786-476-8790
-
New Port Richey, Florida, Förenta staterna, 34653
- Rekrytering
- Advanced Research Institute, Inc /ID# 281062
-
Kontakt:
- Site Coordinator
- Telefonnummer: 727-835-3261
-
Orlando, Florida, Förenta staterna, 32825
- Rekrytering
- Digestive And Liver Center Of Florida - Orlando /ID# 280924
-
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Georgia
-
Macon, Georgia, Förenta staterna, 31201
- Rekrytering
- Gastroenterology Associates of Central Georgia /ID# 280464
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Roswell, Georgia, Förenta staterna, 30076
- Rekrytering
- Gastroenterology Consultants - Roswell /ID# 281235
-
Kontakt:
- Site Coordinator
- Telefonnummer: 404-596-4480
-
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Idaho
-
Boise, Idaho, Förenta staterna, 83706
- Rekrytering
- Treasure Valley Medical Research /ID# 281778
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Illinois
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Gurnee, Illinois, Förenta staterna, 60031
- Rekrytering
- Illinois Gastroenterology Group /ID# 283933
-
Kontakt:
- Site Coordinator
- Telefonnummer: 224-441-2217
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Oak Lawn, Illinois, Förenta staterna, 60453
- Rekrytering
- Southwest Gastroenterology - Oak Lawn /ID# 280841
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40218
- Rekrytering
- Gastroenterology Health Partners /ID# 284144
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Louisiana
-
Shreveport, Louisiana, Förenta staterna, 71103
- Rekrytering
- Willis-Knighton Medical Center /ID# 280572
-
Kontakt:
- Site Coordinator
- Telefonnummer: 318-212-2863
-
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Mississippi
-
Flowood, Mississippi, Förenta staterna, 39232
- Rekrytering
- Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967
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Missouri
-
St Louis, Missouri, Förenta staterna, 63141
- Rekrytering
- Specialists In Gastroenterology /ID# 283939
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-
Nevada
-
Las Vegas, Nevada, Förenta staterna, 89128
- Rekrytering
- Vector Clinical Trials /ID# 280843
-
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New York
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New York, New York, Förenta staterna, 10075
- Rekrytering
- New York Gastroenterology Associates - Upper East Side /ID# 281767
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Ohio
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Englewood, Ohio, Förenta staterna, 45415
- Rekrytering
- Dayton Gastroenterology - Englewood /ID# 284065
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Westlake, Ohio, Förenta staterna, 44145
- Rekrytering
- Gastro Intestinal Research Institute of Northern Ohio /ID# 283860
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02905
- Rekrytering
- University Gastroenterology - Providence - Staniford Street /ID# 280919
-
-
Tennessee
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Memphis, Tennessee, Förenta staterna, 38104
- Rekrytering
- Gastro One - Memphis /ID# 283948
-
-
Texas
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Bellaire, Texas, Förenta staterna, 77401
- Rekrytering
- Novel Research - Bellaire /ID# 280925
-
Georgetown, Texas, Förenta staterna, 78628
- Rekrytering
- Amel Med /ID# 283864
-
Houston, Texas, Förenta staterna, 77090
- Rekrytering
- Integrity Advanced Therapeutics /ID# 283871
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San Antonio, Texas, Förenta staterna, 78229
- Rekrytering
- Southern Star Research Institute /ID# 280822
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-
Washington
-
Bellevue, Washington, Förenta staterna, 98004
- Rekrytering
- Washington Gastroenterology - Bellevue /ID# 283966
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Tacoma, Washington, Förenta staterna, 98405
- Rekrytering
- Washington Gastroenterology - Tacoma /ID# 284143
-
Vancouver, Washington, Förenta staterna, 98664
- Rekrytering
- The Vancouver Clinic /ID# 280497
-
Kontakt:
- Site Coordinator
- Telefonnummer: 360-397-3388
-
-
-
-
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Taichung, Taiwan, 40447
- Rekrytering
- China Medical University Hospital /ID# 280630
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andra namn:
|
|
Experimentell: 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
Andra namn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andra namn:
|
|
Experimentell: 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
Andra namn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andra namn:
|
|
Experimentell: 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
Andra namn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
Andra namn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Experimentell: 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
Andra namn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Experimentell: 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
Andra namn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Experimentell: 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
Andra namn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Experimentell: 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
Andra namn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
|
Experimentell: 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
Andra namn:
Intravenous/Subcutaneous/Intramuscular Injection/Infusion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission
Tidsram: 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
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: ABBVIE INC., AbbVie
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
31 juli 2026
Primärt slutförande (Beräknad)
1 oktober 2031
Avslutad studie (Beräknad)
1 oktober 2031
Studieregistreringsdatum
Först inskickad
7 juli 2026
Först inskickad som uppfyllde QC-kriterierna
7 juli 2026
Första postat (Faktisk)
13 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- M26-266
- 2026-525960-16-00 (Annan identifierare: EU CT)
- 2026-525959-86-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Kriterier för IPD Sharing Access
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .