A study comparing the efficacy and safety of Vedolizumab with and without Upadacitinib in adults with moderate to severe active Crohn's disease (VICTRIVA)
Summary description of the study
Crohn's disease (CD) is a serious, chronic condition that can cause inflammation and painful open sores (ulcers) throughout the intestine, particularly in the colon. Common symptoms include diarrhea, bleeding, and abdominal pain. A cure is not known, but some available medications can reduce inflammation and decrease the likelihood of disease recurrence. For patients whose disease occurs in flares (known as moderately to severely active CD), this study investigates whether the combination of two different medications in the first three months of the study (this period is referred to as the induction phase) can better control symptoms than a single medication alone. Once symptoms are under control, one of the medications (Vedolizumab) may be sufficient to manage symptoms over a longer period (this is referred to as the maintenance phase). Vedolizumab and Upadacitinib are individually approved as medications for CD; however, the combination of these medications is not yet approved. The main goal of this study is to find out how effective Vedolizumab in combination with Upadacitinib (this is referred to as dual-targeted therapy or DTT) is in monitoring CD symptoms compared to the administration of Vedolizumab alone.
(BASEC)
Intervention under investigation
The main goal of this study is to find out how effective Vedolizumab is in controlling the symptoms of Crohn's disease when administered together with Upadacitinib, compared to administration alone. This is referred to as dual-targeted therapy. First, the study aims to determine how well this therapy works compared to Vedolizumab over 3 months (12 weeks), based on 2 different outcomes: Clinical outcomes and endoscopic outcomes. • The Crohn's Disease Activity Index (CDAI) will be used to assess clinical outcomes. Researchers will check whether the participant's condition has improved. The Simple Endoscopic Score for Crohn's Disease (SES CD) will be used to assess endoscopic outcomes. Researchers will check whether the SES-CD score after treatment is lower than at the start of the study (baseline). Second, the study aims to learn more about how well the DTT works over 12 weeks compared to Vedolizumab alone. Researchers will check how well the treatment controls or even improves the participants' condition after 12 weeks using values. The study consists of 4 parts: screening, induction, maintenance, and follow-up.
(BASEC)
Disease under investigation
Crohn's disease
(BASEC)
The participant has a diagnosis of Crohn's disease that has been established at least 3 months prior to screening through clinical and endoscopic findings and confirmed by a histopathological finding. Furthermore, they should have a confirmed diagnosis of moderately to severely active Crohn's disease according to the Crohn's Disease Activity Index. The participant has evidence of mucosal inflammation based on the Simple Endoscopic Score for Crohn's Disease. The participant does not tolerate corticosteroids, immunomodulators, or biological therapies well or at all. (BASEC)
Exclusion criteria
The participant has the following diagnoses: - Current ulcerative colitis or indeterminate colitis. - Infection(s) that need to be treated with intravenous anti-infectives within 30 days prior to study start or with oral/intramuscular anti-infectives within 14 days prior to study start. - An active infection during the screening period or had an infection within 30 days prior to screening or a persistent chronic infection. (BASEC)
Trial sites
Basel, Bern, Zurich
(BASEC)
Sponsor
ICON Clinical Research (Switzerland) GmbH
(BASEC)
Contact
Contact Person Switzerland
Pooja Oberai
+1 9175366958
Pooja.Oberai@cluttertakeda.comTakeda Development Center Americas, Inc.
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
20.05.2025
(BASEC)
ICTRP Trial ID
NCT06227910 (ICTRP)
Official title (approved by ethics committee)
Vedolizumab-3043 Eine randomisierte, doppelblinde, placebokontrollierte Phase-IIIb-Studie zur Beurteilung der kurz- und langfristigen Wirksamkeit und Sicherheit einer dualen, gezielten Therapie mit intravenös verabreichtem Vedolizumab und oral verabreichtem Upadacitinib im Vergleich zu intravenös verabreichter Vedolizumab-Monotherapie zur Behandlung erwachsener Patienten mit mässig bis schwergradig aktivem Morbus Crohn (BASEC)
Academic title
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 (ICTRP)
Public title
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease (ICTRP)
Disease under investigation
Crohn's Disease (ICTRP)
Intervention under investigation
Drug: VedolizumabDrug: UpadacitinibDrug: Placebo (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
1. 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.
2. The participant has a confirmed diagnosis of moderately to severely active CD as
assessed by CDAI of 220-450.
3. The participant has evidence of mucosal inflammation based on the SES-CD: SES-CD
score (excluding the presence of narrowing component) of >=6 (or >=4 for
participants with isolated ileal disease), as confirmed by a central reader.
4. The participant has demonstrated an inadequate response to, loss of response to, or
intolerance to corticosteroids, immunomodulators, or biologic therapy.
Exclusion Criteria:
1. The participant has a current diagnosis of ulcerative colitis or indeterminate
colitis.
2. 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.
3. 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.
4. The participant has a history of recurrent or disseminated (including a single
episode) herpes zoster, or disseminated (including a single episode) herpes simplex.
5. 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.
6. The participant has an ostomy or ileoanal pouch.
7. 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).
8. The participant has severe (Child-Pugh C) hepatic impairment. (ICTRP)
not available
Primary and secondary end points
Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12;Percentage of Participants Exhibiting an Endoscopic Response Based on Simple Endoscopic Score for CD (SES-CD) at Week 12 (ICTRP)
Percentage of Participants Achieving 2-item Patient-reported Outcome Measure (PRO2) Based Clinical Remission at Week 12;Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at 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;Percentage of Participants Exhibiting a Clinical Response Based on the CDAI at Week 12;Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 52;Percentage of Participants Exhibiting an Endoscopic Response Based on SES-CD at Week 52;Percentage of Participants Achieving 2-item PRO2 Based Clinical Remission at Week 52;Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at 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;Percentage of Participants Exhibiting a Clinical Response Based on the CDAI at Week 52 (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Study DirectorTakeda Contact, medinfoUS@takeda.com, +1-877-825-3327, Takeda (ICTRP)
Secondary trial IDs
2023-509391-42-00, Vedolizumab-3043 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06227910 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available