396 Participants Needed

Vedolizumab + Upadacitinib for Crohn's Disease

(VICTRIVA Trial)

Recruiting at 141 trial locations
TC
MB
Overseen ByMatthew Barnes
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Takeda
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have had an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy, which might imply changes to current treatments.

What data supports the effectiveness of the drugs Vedolizumab and Upadacitinib for Crohn's Disease?

Vedolizumab has been shown to be effective for Crohn's disease in patients who did not respond to other treatments, and Upadacitinib has demonstrated positive results in clinical trials and real-world settings, showing improvement in patients with moderate-to-severe Crohn's disease.12345

What safety data exists for Vedolizumab and Upadacitinib in humans?

Upadacitinib was found to be well-tolerated over 30 months in patients with Crohn's disease. Vedolizumab has been associated with some adverse events, including serious ones, but is generally considered safe for Crohn's disease and ulcerative colitis, with longer-term studies needed to fully understand its safety profile.56789

How is the drug combination of Vedolizumab and Upadacitinib unique for treating Crohn's Disease?

This treatment is unique because it combines Vedolizumab, a biologic drug that targets specific proteins involved in gut inflammation, with Upadacitinib, an oral medication that inhibits Janus kinase (JAK), a protein involved in immune response. This combination may offer a novel approach by targeting different pathways in the immune system compared to other treatments.13101112

What is the purpose of this trial?

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.

Research Team

SD

Study Director

Principal Investigator

Takeda

Eligibility Criteria

Adults with moderately to severely active Crohn's Disease who haven't responded well to or can't tolerate corticosteroids, immunomodulators, or biologics. They must have a confirmed diagnosis for at least 3 months and show bowel inflammation on specific tests.

Inclusion Criteria

I was diagnosed with Crohn's disease over 3 months ago, confirmed by tests and a biopsy.
My Crohn's disease is moderate to severe, with a CDAI score between 220-450.
My test shows significant inflammation in my intestines.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive vedolizumab and upadacitinib or vedolizumab and placebo for 12 weeks

12 weeks
4 visits (in-person)

Maintenance

Participants who respond to induction treatment receive vedolizumab monotherapy for 40 weeks

40 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

Treatment Details

Interventions

  • Upadacitinib
  • Vedolizumab
Trial Overview The trial is testing if combining Vedolizumab and Upadacitinib (dual therapy) is better than using Vedolizumab alone (monotherapy) in reducing bowel inflammation after 12 weeks. Participants will first receive dual therapy, then responders continue with monotherapy for an additional 40 weeks.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Main Study Maintenance Phase: Vedolizumab MonotherapyExperimental Treatment1 Intervention
Participants who achieve a CDAI reduction of \>=70 points from baseline at Week 12 will receive vedolizumab 300 mg IV infusion (monotherapy), every 8 weeks (Q8W) starting at Week 14 to 52. The Q8W vedolizumab monotherapy may be escalated to Q4W at the investigator's discretion.
Group II: Double-blind Induction Phase: Vedolizumab + UpadacitinibExperimental Treatment2 Interventions
Participants will receive vedolizumab 300 mg intravenous (IV) infusion at Weeks 0, 2, 6 and 10 along with upadacitinib 45 mg, orally, once daily (QD) for 12 weeks.
Group III: Double-blind Induction Phase: Vedolizumab + PlaceboPlacebo Group2 Interventions
Participants will receive vedolizumab IV 300 mg infusion, at Weeks 0, 2, 6 and 10 along with upadacitinib matched placebo, orally, QD for 12 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials
1,255
Recruited
4,219,000+
Dr. Naoyoshi Hirota profile image

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber profile image

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Universitรฉ de Montpellier

Findings from Research

In a real-world study of 45 patients with moderate to severe Crohn's disease treated with upadacitinib, 63.6% achieved a clinical response and 27.2% achieved clinical remission after 3 months, indicating its efficacy in managing the disease.
The safety profile of upadacitinib was acceptable, with 26.7% of patients experiencing adverse events, and only 4.5% having serious adverse events without any reported mortality.
Multicentre Real-world Experience of Upadacitinib in the Treatment of Crohn's Disease.Chugh, R., Braga-Neto, MB., Fredrick, TW., et al.[2023]
Vedolizumab demonstrated the ability to maintain steroid-free clinical remission in 27.2% of patients with Crohn's disease and 40.5% of patients with ulcerative colitis at week 54, indicating its efficacy in long-term treatment.
The safety profile of vedolizumab was reasonable, with no deaths reported and only 7.2% of patients experiencing severe adverse events, although a notable number of patients, especially those with Crohn's disease, experienced a loss of response during the first year of treatment.
One-year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: a prospective multicentre cohort study.Amiot, A., Serrero, M., Peyrin-Biroulet, L., et al.[2022]
In a study of 53 patients with ulcerative colitis and Crohn's disease receiving vedolizumab therapy, 20% of ulcerative colitis patients and 14.3% of Crohn's disease patients achieved remission by week 30, indicating some efficacy in a treatment-refractory population.
Despite some patients responding to vedolizumab, a significant portion (48% for ulcerative colitis and 39.4% for Crohn's disease) did not respond satisfactorily, highlighting the need for alternative treatment options for those not achieving remission.
Real-World Outcomes of Vedolizumab Therapy in Ulcerative Colitis and Crohn's Disease at a Tertiary Referral Center.Hoffmann, P., Krisam, J., Stremmel, W., et al.[2018]

References

Multicentre Real-world Experience of Upadacitinib in the Treatment of Crohn's Disease. [2023]
One-year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: a prospective multicentre cohort study. [2022]
Real-World Outcomes of Vedolizumab Therapy in Ulcerative Colitis and Crohn's Disease at a Tertiary Referral Center. [2018]
Upadacitinib Is Safe and Effective for Crohn's Disease: Real-World Data from a Tertiary Center. [2023]
Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. [2022]
Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases. [2021]
Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn's disease - a systematic review with meta-analysis. [2023]
Vedolizumab as Induction and Maintenance for Inflammatory Bowel Disease: 12-month Effectiveness and Safety. [2020]
Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Budget Impact of Adding Vedolizumab to a Health Plan Formulary as Another First-Line Biologic Option for Ulcerative Colitis and Crohn's Disease. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Upadacitinib Induction and Maintenance Therapy for Crohn's Disease. [2023]
Higher Trough Vedolizumab Concentrations During Maintenance Therapy are Associated With Corticosteroid-Free Remission in Inflammatory Bowel Disease. [2020]
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