A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Vedolizumab, Upadacitinib, Placebo.
- Кому может быть актуально
- Состояния в реестре: Crohn's Disease. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Австрия, Бельгия, Бразилия, Канада +21
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized, Double-Blind, Phase 3b Study to Evaluate the Short- and Long-Term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn's Disease
Обзор
The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants. All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks. Participants responding to the treatment will then receive vedolizumab only (monotherapy) for an additional 40 weeks. During the study, participants will visit their study clinic 15 times.
Подробное описание
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderately to severely active CD. The study will look at the efficacy and safety of vedolizumab with and without upadacitinib. The study will enroll approximately 396 patients. Participants will be assigned in a 1:1 ratio to one of the two treatment groups in the 12-weeks Induction Phase:
* Induction Phase: Vedolizumab + Upadacitinib * Induction Phase: Vedolizumab + Placebo
Participants who achieve a Crohn's disease activity index (CDAI) reduction of greater than or equal to (\>=)70 points from baseline at Week 12 will enter the main study Maintenance Phase (40 weeks) of the study to receive vedolizumab monotherapy. Participants will be followed for a further 18-week safety follow-up period up to Week 70.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 70 weeks.
Вмешательства
- Препарат Vedolizumab
Vedolizumab IV infusion. - Препарат Upadacitinib
Upadacitinib over-encapsulated tablets. - Препарат Placebo
Upadacitinib matched placebo capsules.
Первичные конечные точки
- Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12 [Срок оценки: Week 12]
- Percentage of Participants Exhibiting an Endoscopic Response Based on Simple Endoscopic Score for CD (SES-CD) at Week 12 [Срок оценки: Week 12]
Вторичные конечные точки (10)
- Percentage of Participants Achieving 2-item Patient-reported Outcome Measure (PRO2) Based Clinical Remission at Week 12 [Срок оценки: Week 12]
- Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12 [Срок оценки: Week 12]
- Percentage of Participants Exhibiting Corticosteroid-free Clinical Remission in Participants who Were Taking Corticosteroids at Baseline Based on the CDAI at Week 12 [Срок оценки: Week 12]
- Percentage of Participants Exhibiting a Clinical Response Based on the CDAI at Week 12 [Срок оценки: Week 12]
- Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 52 [Срок оценки: Week 52]
- Percentage of Participants Exhibiting an Endoscopic Response Based on SES-CD at Week 52 [Срок оценки: Week 52]
- Percentage of Participants Achieving 2-item PRO2 Based Clinical Remission at Week 52 [Срок оценки: Week 52]
- Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 52 [Срок оценки: Week 52]
- Percentage of Participants Exhibiting Corticosteroid-free Clinical Remission in Participants who Were Taking Corticosteroids at Baseline Based on the CDAI at Week 52 [Срок оценки: Week 52]
- Percentage of Participants Exhibiting a Clinical Response Based on the CDAI at Week 52 [Срок оценки: Week 52]
Критерии участия
Критерии включения
- The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence and corroborated by a histopathology report.
- The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450.
- The participant has evidence of mucosal inflammation based on the SES-CD: SES-CD score of >=6 (or >=4 for participants with isolated ileal disease), as confirmed by a central reader.
- The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy.
Критерии исключения
- The participant has a current diagnosis of ulcerative colitis or indeterminate colitis.
- The participant has infection(s) requiring treatment with IV anti-infectives within 30 days prior to baseline or oral/intramuscular anti-infectives within 14 days prior to baseline.
- The participant has evidence of an active infection during the screening period, or clinically significant infection within 30 days prior to screening, or ongoing chronic infection.
- The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex.
- The participant has any of the following ongoing known complications of CD: abscess (abdominal or peri-anal); symptomatic bowel strictures; 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; fulminant colitis; toxic megacolon; or any other manifestation that might require surgery while enrolled in the study.
- The participant has an ostomy or ileoanal pouch.
- The participant has severe renal impairment, defined as an estimated glomerular filtration rate of <30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2).
- The participant has severe (Child-Pugh C) hepatic impairment.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 19 центров
- UCSD Medical Center — La Jolla
- Keck Medicine Of USC - USC Healthcare Center 1 — Los Angeles
- Peak Gastroenterology Associates — Colorado Springs
- GI PROS, Inc. — Naples
- Orlando Health Ambulatory Care Center — Orlando
- USF Health Morsani Center for Advanced Healthcare — Tampa
- Indiana University (IU) Health University Hospital — Indianapolis
- University of Kentucky — Lexington
- … и ещё 11 центров
Канада · 9 центров
- Heritage Medical Research Clinic - University Of Calgary — Calgary
- University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre — Winnipeg
- Dalhousie University — Halifax
- Barrie GI Associates — Barrie
- McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI) — Hamilton
- Taunton Surgical Centre-Oshawa Clinic — Oshawa
- Toronto Immune and Digestive Health Institute (TIDHI) — Toronto
- Toronto Digestive Disease Associates — Vaughan
- … и ещё 1 центр
Франция · 8 центров
- CHU d'Amiens-Picardie - Hopital SUD — Amiens
- Hopital Huriez - CHRU de Lille — Lille
- Chu - Hopital Nord — Marseille
- Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu — Nantes
- Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque — Pessac
- CHU St Etienne Hopital Nord — Saint-Etienne
- Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil — Toulouse
- Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois — Vandœuvre-lès-Nancy
South Korea · 8 центров
Список центров уточняется — проверьте первичный протокол.
Бразилия · 7 центров
- Hospital Universitario Cajuru — Curitiba
- Faculdade de Medicina de Botucatu — Botucatu
- Centro de Estudos Clinico do Interior Paulista - CECIP — Jaú
- Pesquisare Saude — Santo André
- Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filh — Rio de Janeiro
- Hospital das Clinicas of the University of Sao Paulo (Hospital das Clinicas da Faculdade d — São Paulo
- Unidade de Pesquisa Clinica UPC Hospital das Clinicas da Faculdade de Medicina de Ribeirao — São Paulo
Германия · 7 центров
- Krankenhaus Waldfriede e.V. — Berlin
- Agaplesion Markus Krankenhaus — Frankfurt am Main
- Studiengesellschaft BSF — Halle
- Universitaetsklinikum Jena — Jena
- Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel — Kiel
- St. Marien- und St. Annastiftskrankenhaus — Ludwigshafen
- Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik — Mannheim
Италия · 6 центров
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Испания · 6 центров
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Тайвань · 6 центров
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Австрия · 5 центров
- Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universita — Vienna
- Medical University Innsbruck — Innsbruck
- Johannes Kepler Universitat Linz (JKU) — Linz
- Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss — Salzburg
- Krankenhaus der Barmherzigen Brueder Wien — Vienna
Бельгия · 5 центров
- Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel — Brussels
- Imelda GI Clinical Research Center — Bonheiden
- Universitair Ziekenhuis Gent — Ghent
- University Hospitals Leuven — Leuven
- Centre Hospitalier Chretien MontLegia — Liège
Израиль · 5 центров
- Soroka Medical Center — Beersheba
- Rambam Health Care Campus (RHCC) — Haifa
- … и ещё 3 центра
Польша · 5 центров
Список центров уточняется — проверьте первичный протокол.
Чехия · 4 центра
- Nemocnice Ceske Budejovice, a.s. — České Budějovice
- Fakultni Nemocnice Hradec Kralove — Hradec Králové
- Hepato-Gastroenterologie HK, s.r.o. — Hradec Králové
- IBD Clinical and Research centre — Prague
Нидерланды · 4 центра
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Норвегия · 4 центра
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Швеция · 4 центра
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Швейцария · 4 центра
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Великобритания · 4 центра
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Хорватия · 3 центра
- Poliklinika Borzan d.o.o. — Osijek
- Clinical Hospital Center Rijeka — Rijeka
- University Hospital Centre Sestre Milosrdnice — Zagreb
Греция · 3 центра
- University of Athens School of Medicine, Alexandra General Hospital — Athens
- Metaxa Cancer Hospital — Piraeus
- University Hospital of Heraklion — Heraklion
Венгрия · 3 центра
- Central Hospital of Northern Pest - Military Hospital — Budapest
- Semmelweis Egyetem — Budapest
- Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent-Gyorgyi Albert Klinikai Kozpont — Szeged
Ирландия · 3 центра
- Adelaide, Meath and National Children's Hospital — Dublin
- University College Dublin (UCD) - St. Vincent's University Hospital (SVUH) — Dublin
- Beaumont Hospital — Dublin
Португалия · 3 центра
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Дания · 2 центра
- Aalborg Hospital — Aalborg
- Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling — Hvidovre
Словения · 1 центр
Список центров уточняется — проверьте первичный протокол.
Публикации
- Danese S, Sands BE, Feagan BG, Jairath V, Panaccione R, Peyrin-Biroulet L, Irving PM, Schreiber S, Dotan I, Ferrante M, D'Haens GR, Jones S, Freire M, Lindner D, Adsul S, Oberai P, Colombel JF. Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease. Contemp Clin Trials Commun. 2025 Nov 24;48:101574. PMID 41403476
Идентификаторы
NCT: NCT06227910 · Vedolizumab-3043 · 2023-509391-42-00