Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis

Официальное название

Efficacy and Safety Analysis of Sequential Treatment of Moderate to Severe Ulcerative Colitis With Vedolizumab and Upadacitinib: A Multicenter Prospective Randomized Controlled Clinical Study

Обзор

It's of great importance to effectively induce and maintain disease remission in patients with moderate to severe ulcerative colitis (UC). Vedolizumab (VDZ) is known for its high safety profile and confirmed therapeutic efficacy in UC treatment. However, according to the experience in clinical practice, the effect onset speed of vedolizumab is relatively slow. Upadacitinib (UPA), however, works quickly, which complements the defect of slow onset of VDZ induction. However, the safety of UPA used in situations such as infection and tumors is inferior to that of VDZ, and long-term use requires testing for the risk of adverse events such as deep vein thrombosis. Therefore, if the advantages of long-term maintenance therapy safety of VDZ and rapid induced remission of UPA are fully utilized, the combination of VDZ and UPA induction for 8 weeks, followed by the use of single drug VDZ in maintenance therapy, can maximize the clinical benefits of UC patients. Due to the lack of high-level clinical research data at home and abroad, we plan to conduct a multicenter prospective randomized controlled clinical study to provide the evidence-based basis for the efficacy analysis of the sequential treatment of moderate to severe UC patients with VDZ and UPA.

Вмешательства

• Препарат Upadacitinib
  Oral upadacitinib 45mg/d for 8 weeks in the induction therapy.
• Препарат Vedolizumab
  Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.

Первичные конечные точки

• 8th-week endoscopic remission rate [Срок оценки: 8th-week]

Вторичные конечные точки (11)

• Clinical remission rate at the 8th week [Срок оценки: 8th-week]
• clincial response rate at 8th-week [Срок оценки: 8th-week]
• Endoscopic response rate at 8th-week [Срок оценки: 8th-week]
• normalization rate of CRP at the 8th week [Срок оценки: 8th-week]
• life quality score at the 8th week [Срок оценки: 8th-week]
• Clinical remission rate at the 54th-week [Срок оценки: 54th-week]
• Clinical response rate at 54th week [Срок оценки: 54th week]
• endoscopic remission rate at 54th-week [Срок оценки: 54th-week]
• Endoscopic response rate at 54th-week [Срок оценки: 54th-week]
• normalization rate of CRP at the 54th week [Срок оценки: 54th-week]
• life quality score at the 54th week [Срок оценки: 54th-week]

Критерии участия

Критерии включения

• Diagnosed UC for at least 3 months, including endoscopic evidence supporting UC and histopathological evidence supporting UC diagnosis
• Suffering from moderate to severe UC, defined as modified Mayo score ≥ 4 and endoscopic subscale (ESS) ≥ 2
• Indications for VDZ or UPA application

Критерии исключения

• Patients who are unable to take oral UPA and receive regular intravenous VDZ infusion therapy
• Evidence of toxic megacolon was found during screening
• Previously underwent extensive colectomy, subtotal resection, or total colectomy, ileostomy, or colostomy due to UC
• Subjects who require surgery due to UC or plan to undergo elective surgery during the study period
• There is evidence indicating that the subjects suffer from severe, progressive, or uncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurological diseases
• Evidence of active hepatitis B or C infection during screening

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• the Sixth Affiliated Hospital of Sun Yat-Sen University — Гуанчжоу

Публикации

• Yao J, Wu H, Wu L, Yu Q, Cao X, Xie T, Zhong X, Chen H, Wu J, Liu X, Shi L, Zhang M, Peng X, Deng J, Wang W, Liu T, Su T, Yang H, Xia D, Zhi M. Combined Upadacitinib and Vedolizumab as 8-Week Induction Therapy for Moderate-to-Severe Ulcerative Colitis: A Multicenter, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 May 22:S1542-3565(26)00388-5. doi: 10.1016/j.cgh.2026.05.010. Online a PMID 42173298

Идентификаторы

NCT: NCT06095596 · 2023ZSLYEC-469

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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