Vedolizumab + Adalimumab/Ustekinumab for Crohn's Disease
Recruiting in Palo Alto (17 mi)
+56 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Takeda
Must not be taking: Anti-integrin antibodies
Disqualifiers: Ulcerative colitis, Abdominal abscess, Tuberculosis, Hepatitis B, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab together with ustekinumab in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment.
The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A.
Each participant will be followed up for at least 26 weeks after the last dose of treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug combination Vedolizumab + Adalimumab/Ustekinumab for Crohn's Disease?
Research shows that Adalimumab can help patients with Crohn's disease who did not respond well to another drug called infliximab. Additionally, Ustekinumab and Vedolizumab have been compared and used effectively in patients who did not respond to other treatments, suggesting they may be beneficial in combination.
12345Is the combination of Vedolizumab, Adalimumab, and Ustekinumab safe for humans?
Research shows that Vedolizumab, Adalimumab, and Ustekinumab have been studied for safety in people with Crohn's disease. These studies generally indicate a favorable safety profile, meaning they are considered safe for use in humans, although specific safety data for the combination of all three is not detailed.
13467How is the combination of Vedolizumab, Adalimumab, and Ustekinumab unique for treating Crohn's disease?
This treatment is unique because it combines three different drugs, each with a distinct mechanism of action, to target Crohn's disease. Vedolizumab works by blocking white blood cells from entering the gut, Adalimumab is an anti-TNF drug that reduces inflammation, and Ustekinumab targets specific proteins involved in inflammation. This combination may offer a new option for patients who have not responded to other treatments.
6891011Eligibility Criteria
Adults with moderate to severe Crohn's Disease who have had an inadequate response, lost response, or intolerance to certain treatments. They must have a confirmed diagnosis for at least 3 months and meet specific disease severity scores. Not eligible if they've had extensive colon resections, certain infections like TB or HIV, previous nonresponse to multiple treatments, or any immunodeficiency.Inclusion Criteria
I was diagnosed with Crohn's disease over 3 months ago, confirmed by an endoscopy.
My Crohn's disease is active, with a high severity score.
I am in remission at 26 weeks or showing significant improvement.
+7 more
Exclusion Criteria
I have been diagnosed with ulcerative colitis or indeterminate colitis.
I have a perianal fistula with an abscess.
I had major surgery on my colon with at least 2 parts left, over 6 months ago.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Part A
Participants receive dual targeted treatment with vedolizumab and either adalimumab or ustekinumab
26 weeks
Multiple visits for IV and SC administration
Treatment Part B
Participants who achieve clinical remission in Part A receive vedolizumab monotherapy
16 weeks
IV administration every 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
26 weeks
Participant Groups
The trial is testing the effectiveness of vedolizumab IV in combination with either adalimumab or ustekinumab in treating Crohn's Disease. Participants first receive dual therapy (Part A), then those responding continue with only vedolizumab (Part B). The follow-up period lasts at least 26 weeks post-treatment.
3Treatment groups
Experimental Treatment
Group I: Part B: Vedolizumab MonotherapyExperimental Treatment1 Intervention
Participants who achieve clinical remission in Part A will receive vedolizumab IV 300 mg monotherapy, Q8W from Week 30 until Week 46.
Group II: Part A, Cohort 2: Vedolizumab + UstekinumabExperimental Treatment2 Interventions
Participants will receive vedolizumab IV 300 mg, at Weeks 0, 2, and 6, then Q8W until Week 22 and ustekinumab IV 520, 390, or 260 mg (weight-based), then SC 90 mg 8 weeks after initial IV dose, then Q8W until Week 24.
Group III: Part A, Cohort 1: Vedolizumab + AdalimumabExperimental Treatment2 Interventions
Participants will receive vedolizumab IV 300 mg, at Weeks 0, 2, and 6, then every 8 weeks (Q8W) until Week 22 and adalimumab SC 160, 80, and 40 mg at Weeks 0, 2, and 4, respectively, then 40 mg every 2 weeks (Q2W) until Week 26.
Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
🇺🇸 Approved in United States as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
- Hidradenitis suppurativa
🇨🇦 Approved in Canada as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
🇯🇵 Approved in Japan as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Digestive Health SpecialsitsDothan, AL
University of California San Diego Health (UCSD)La Jolla, CA
Cedars-Sinai Medical CenterLos Angeles, CA
Medical Research Center of Connecticut, LLCHamden, CT
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
TakedaLead Sponsor
References
An indirect comparison of ustekinumab and vedolizumab in the therapy of TNF-failure Crohn's disease patients. [2019]An indirect comparison of ustekinumab versus vedolizumab in patients with active moderate-to-severe Crohn's disease who were nonresponsive or intolerant to previous TNF-antagonist therapy.
Adalimumab maintenance therapy for Crohn's disease with intolerance or lost response to infliximab: an open-label study. [2015]Adalimumab is effective in inducing remission in patients with active Crohn's disease who had secondary failure to infliximab therapy.
Comparative Safety and Effectiveness of Biologic Therapy for Crohn's Disease: A CA-IBD Cohort Study. [2023]We compared the safety and effectiveness of tumor necrosis factor α (TNF-α) antagonists vs vedolizumab vs ustekinumab in patients with Crohn's disease (CD) in a multicenter cohort (CA-IBD).
Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial. [2022]Active-comparator trials are important to inform patient and physician choice. We aimed to evaluate the efficacy and safety of monotherapy with either ustekinumab or adalimumab in biologic-naive patients with moderately to severely active Crohn's disease.
The outcome of Crohn's disease patients refractory to anti-TNF and either vedolizumab or ustekinumab. [2021]The aims of this study were to describe outcomes in patients with Crohn's disease who fail anti-tumor necrosis factor (TNF) and either vedolizumab or ustekinumab.
Real-World Evidence Comparing Vedolizumab and Ustekinumab in Antitumor Necrosis Factor-Experienced Patients With Crohn's Disease. [2023]Many patients with Crohn's disease (CD) lose response or become intolerant to antitumor necrosis factor (TNF) therapy and subsequently switch out of class. We compared the effectiveness and safety of ustekinumab to vedolizumab in a large, geographically diverse US population of TNF-experienced patients with CD.
Real-World Effectiveness and Safety of Ustekinumab in Elderly Crohn's Disease Patients. [2023]The efficacy and safety profile of ustekinumab (UST) in Crohn's disease (CD) is favorable; however, data in elderly patients are lacking. We aimed to assess the safety and efficacy of UST in elderly CD.
Systematic review with meta-analysis: the effectiveness of either ustekinumab or vedolizumab in patients with Crohn's disease refractory to anti-tumour necrosis factor. [2022]Ustekinumab and vedolizumab are commonly used after anti-tumour necrosis factor (TNF) failure in patients with Crohn's disease (CD). No randomised controlled trial has compared these drugs.
Comparative effectiveness of ustekinumab vs. vedolizumab for anti-TNF-naïve or anti-TNF-exposed Crohn's disease: a multicenter cohort study. [2023]Ustekinumab and vedolizumab are both effective for treating Crohn's disease (CD). However, no head-to-head trials have been conducted thus far. We aimed to compare the effectiveness of ustekinumab and vedolizumab in CD patients either naïve or exposed to tumor necrosis factor-alpha inhibitors (TNFi).
Ustekinumab is associated with superior effectiveness outcomes compared to vedolizumab in Crohn's disease patients with prior failure to anti-TNF treatment. [2021]Both vedolizumab and ustekinumab can be considered for the treatment of Crohn's disease (CD) when anti-TNF treatment fails. However, head-to-head trials are currently not available or planned.
An Objective Comparison of Vedolizumab and Ustekinumab Effectiveness in Crohn's Disease Patients' Failure to TNF-Alpha Inhibitors. [2022]The use of ustekinumab and vedolizumab as second-line therapies in patients with Crohn's disease (CD) in which tumour necrosis factor alpha inhibitors (TNFi) failed is still debated. The aim of this study was to compare, in a large multicenter observational retrospective cohort, the effectiveness of ustekinumab and vedolizumab as second-line therapies, as assessed by clinical and objective outcomes including endoscopy and gastrointestinal imaging.