Efficacy and Safety of Risankizumab Compared to Vedolizumab in Adult Patients with Moderate to Severe Ulcerative Colitis
Zusammenfassung der Studie
Ulcerative colitis is a chronic inflammation of the colon that leads to stomach pain, cramps, and diarrhea. This study assesses the efficacy and safety of Risankizumab compared to Vedolizumab in treating adult patients with ulcerative colitis who have not yet received targeted therapy. Targeted therapies are understood to be medications that block specific immune cells, thereby containing or controlling inflammation. Patients aged between 18 and 80 years, diagnosed with moderate to severe active ulcerative colitis, will be enrolled. At the beginning of the study, they will be randomly assigned to either the Risankizumab or the Vedolizumab group. The aim of the study is to determine how many patients in the Risankizumab or Vedolizumab group show a reduction in inflammation in the colon after 48 weeks of treatment. For this purpose, a long flexible tube with a tiny video camera will be inserted into the rectum to assess the inside of the intestine (endoscopy). The main risk of treatment with Risankizumab is the impairment of the immune system, which helps the body fight infections and other diseases. This can lead to increased infections. An injection of Risankizumab may also cause skin reactions at the injection site and other allergic reactions. These allergic reactions can be severe or life-threatening. Therefore, the safety of patients in the study will be closely monitored to mitigate these risks. This study also includes treatment with Vedolizumab. Patients will discuss potential risks with the investigator.
(BASEC)
Untersuchte Intervention
This study is 'open', meaning that both the patients and the investigators know which study treatment the patients are receiving. A computer program will be used to randomly assign patients to either the Risankizumab or the Vedolizumab group. This step helps ensure that the distribution in the groups is similar and that there are not too many differences between the groups. Risankizumab is administered intravenously (using a needle into a vein directly into the bloodstream) or subcutaneously (with a syringe under the skin). Vedolizumab is administered only intravenously.
The Risankizumab group receives the medication intravenously on Day 1, at Week 4, and Week 8. From Week 12, participants will receive a subcutaneous injection every 8 weeks until Week 44 in 2 different doses. The high or low dose of Risankizumab depends on how well the patient responded to the intravenous dose of Risankizumab. The Vedolizumab group receives a consistent dose on Day 1, at Week 2, and Week 6, and then every 8 weeks until Week 46.
During the study, patients will provide blood, urine, and stool samples, undergo an electrocardiogram (measurement of electrical signals in the heart), an endoscopy with intestinal biopsies (small tissue samples will be taken), and fill out questionnaires about their ulcerative colitis symptoms. Some study centers will participate in an abdominal ultrasound examination. Ultrasound is a procedure that uses sound waves to look inside the body.
(BASEC)
Untersuchte Krankheit(en)
Ulcerative colitis
(BASEC)
- Individuals aged 18 to 80 years - Confirmed diagnosis of moderate to severe active ulcerative colitis at least 3 months prior to study initiation - Documented intolerance or inadequate response to one or more of the following drug classes: aminosalicylates, corticosteroids, and immunomodulators (BASEC)
Ausschlusskriterien
- Individuals who have already received targeted therapy for their ulcerative colitis, including but not limited to: Infliximab, Etanercept, Adalimumab, Natalizumab, Certolizumab, Golimumab, Ozanimod, Ustekinumab, Etrolizumab, Vedolizumab, Tofacitinib, Filgotinib, Etrasimod, Guselkumab, Mirikizumab, Upadacitinib, or Risankizumab. - Individuals who have received corticosteroids (intravenously or intramuscularly) within 14 days prior to study initiation or during screening - Individuals who have received a therapeutic enema or suppository (i.e., rectal aminosalicylates/corticosteroids) within 14 days prior to study initiation or during screening, unless required for endoscopy. (BASEC)
Studienstandort
Bern, Luzern, St Gallen, Zürich
(BASEC)
Sponsor
AbbVie Inc. North Chicago USA AbbVie AG Cham
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Franzisca Rusca
+41 41 399 16 89
franzisca.rusca@clutterabbvie.comAbbVie Medical Information
(BASEC)
Allgemeine Auskünfte
AbbVie Deutschland GmbH & Co. KG
+4961117201520
global-clinical-trials@abbvie.com(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Ostschweiz EKOS
(BASEC)
Datum der Bewilligung durch die Ethikkommission
15.05.2025
(BASEC)
ICTRP Studien-ID
CTIS2024-518998-33-00 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who are Naïve to Targeted Therapies (BASEC)
Wissenschaftlicher Titel
A Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who are Nave to Targeted Therapies - M25-540 (ICTRP)
Öffentlicher Titel
A Study to Compare Risankizumab to Vedolizumab in Adult Subjects With Moderate to Severe Ulcerative Colitis (ICTRP)
Untersuchte Krankheit(en)
Ulcerative Colitis
MedDRA version: 20.1Level: LLTClassification code: 10045365Term: Ulcerative colitis Class: 10017947Therapeutic area: Diseases [C] - Digestive System Diseases [C06] (ICTRP)
Untersuchte Intervention
Product Name: ABBV-066, Product Code:PRD10369455, Pharmaceutical Form: SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, Other descriptive name: , Strength: , Product Name: Entyvio 300 mg powder for concentrate for solution for infusion, Product Code:PRD1598541, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: ABBV-066 / Risankizumab, Product Code:PRD10391031, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: (ICTRP)
Studientyp
Interventional clinical trial of medicinal product (ICTRP)
Studiendesign
Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Number of treatment arms in the trial: (ICTRP)
Ein-/Ausschlusskriterien
Inclusion criteria: Subject has confirmed diagnosis of Ulcerative Colitis for at least 3 months prior to Baseline., Subject has active Ulcerative Colitis with an modified Mayo Score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader), Subject has demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids (prednisone or equivalent), and immunomodulators. (ICTRP)
Exclusion criteria: Subject with a current diagnosis of Crohn's disease (CD) or Irritable Bowel Disease (IBD)-unclassified or a history of radiation colitis or ischemic colitis., Subject has received any targeted therapies (TaTs) for UC, including but not limited to infliximab, etanercept, adalimumab, natalizumab, golimumab, ozanimod, ustekinumab, etrolizumab, vedolizumab, tofacitinib, filgotinib, etrasimod, guselkumab, mirikizumab, upadacitinib, and risankizumab., Active systemic infection/Clinically important infection during the last 2 weeks prior to Baseline Visit as assessed by the investigator.
Primäre und sekundäre Endpunkte
nicht verfügbar
Secondary end point(s):The achievement of clinical remission per mMS at Week 48, defined as SFS = 1 and not greater than Baseline, RBS = 0, and a centrally read endoscopy subscore of 0 or 1 (score of 1 modified to exclude friability): non-inferiority of risankizumab vs. vedolizumab test first followed by superiority test. (ICTRP)
Registrierungsdatum
20.03.2025 (ICTRP)
Einschluss des ersten Teilnehmers
11.08.2025 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Bernhard Dodell, global-clinical-trials@abbvie.com, +4961117201520, AbbVie Deutschland GmbH & Co. KG (ICTRP)
Sekundäre IDs
nicht verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
YesAbbVie 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. (ICTRP)
Weitere Informationen zur Studie
https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-518998-33-00 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar