Vedolizumab for Ulcerative Colitis and 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 3
Recruiting
Sponsor: Takeda
Must not be taking: Anti-integrins, MAdCAM-1 antagonists
Disqualifiers: Neurological disorders, Tuberculosis, Hepatitis B, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC).
The participants will be treated with vedolizumab for up to 34 weeks.
During the study, participants will visit their study clinic several times.
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 failed or been intolerant to certain treatments like corticosteroids or TNF-α antagonists, which might imply some changes to your current medication plan. It's best to discuss this with the trial coordinators.
What data supports the effectiveness of the drug Vedolizumab for treating ulcerative colitis and Crohn's disease?
Research shows that Vedolizumab, a drug targeting gut inflammation, is effective for ulcerative colitis and Crohn's disease, with studies indicating it helps patients achieve remission without the need for steroids. Long-term and real-world studies also support its safety and effectiveness in managing these conditions.
12345Is vedolizumab safe for humans?
Vedolizumab has been shown to be generally safe for people with ulcerative colitis and Crohn's disease, with studies noting its safety in both short-term and long-term use.
678910What makes the drug vedolizumab unique for treating ulcerative colitis and Crohn's disease?
Vedolizumab is unique because it is a gut-selective drug that works by blocking certain immune cells from entering the gut, which helps reduce inflammation specifically in the digestive tract. This makes it different from other treatments that affect the entire immune system.
38111213Eligibility Criteria
This trial is for children and teenagers with moderately to severely active ulcerative colitis or Crohn's disease. They must weigh at least 10 kg, have a specific severity of their condition as measured by medical scores, and have tried other treatments like corticosteroids without success. Their vaccinations need to be up-to-date.Inclusion Criteria
Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines
I weigh at least 10 kg.
I was diagnosed with UC or CD over a month ago and my condition is moderate to severe.
+3 more
Exclusion Criteria
I have been diagnosed with indeterminate colitis.
Participants with positive Clostridioides difficile stool test at screening visit
Participants with hypersensitivity or allergies to vedolizumab or any of its excipients
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Induction
Participants receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight
6 weeks
3 visits (in-person)
Maintenance
Participants receive vedolizumab 108 mg SC injection every 2 or 4 weeks based on weight
20 weeks
5-10 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
18 weeks
1 visit (in-person)
Extension
Participants may be eligible to receive continued treatment with vedolizumab SC in an extension study
Participant Groups
The study tests how vedolizumab, given under the skin (subcutaneously), affects young patients with ulcerative colitis or Crohn's disease over a period of up to 34 weeks. The focus is on understanding how their bodies process the medication.
5Treatment groups
Experimental Treatment
Group I: Maintenance Period: Participants ≥30 kg, Vedolizumab 108 mg SC Q2WExperimental Treatment1 Intervention
Participants with clinical response at Week 14 weighing ≥30 kg will receive vedolizumab 108 mg, SC injection, Q2W from Week 14 to Week 32 in the Maintenance Period.
Group II: Maintenance Period: Participants ≥10 to <30 kg, Vedolizumab 108 mg SC Q4WExperimental Treatment1 Intervention
Participants with clinical response at Week 14 weighing ≥10 to \<30 kg will receive vedolizumab 108 mg, SC injection, Q4W from Week 14 to Week 30 in the Maintenance Period.
Group III: Induction Period: Participants ≥30 kg, Vedolizumab (High Dose) IVExperimental Treatment1 Intervention
Participants weighing ≥30 kg will receive vedolizumab (High Dose) IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
Group IV: Induction Period: Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) IVExperimental Treatment1 Intervention
Participants weighing ≥10 to ≤15 kg will receive vedolizumab (Low Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
Group V: Induction Period: Participants >15 to <30 kg, Vedolizumab (Medium Dose) IVExperimental Treatment1 Intervention
Participants weighing \>15 to \<30 kg will receive vedolizumab (Medium Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VVCRD Clinical ResearchGarden Grove, CA
Loma Linda University School of MedicineLoma Linda, CA
Morristown Medical CenterMorristown, NJ
The New York Presbyterian Hospital, Weill Cornell Medical CollegeNew York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
TakedaLead Sponsor
References
Higher Trough Vedolizumab Concentrations During Maintenance Therapy are Associated With Corticosteroid-Free Remission in Inflammatory Bowel Disease. [2020]Vedolizumab is an anti-α4β7 biologic approved for ulcerative colitis [UC] and Crohn's disease [CD]. We aimed to examine the association of maintenance vedolizumab concentrations with remission.
Vedolizumab as Induction and Maintenance for Inflammatory Bowel Disease: 12-month Effectiveness and Safety. [2020]Vedolizumab is approved for moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). We present prospective, 1-year data of the real-world effectiveness and safety of vedolizumab in inflammatory bowel disease.
Real-World Outcomes of Vedolizumab Therapy in Ulcerative Colitis and Crohn's Disease at a Tertiary Referral Center. [2018]Vedolizumab was approved for the therapy of ulcerative colitis and Crohn's disease in mid-2014. Real-world treatment data are necessary for a balanced assessment of its position among other therapeutic options.
Long-term clinical experience with vedolizumab in patients with inflammatory bowel disease. [2022]Vedolizumab, a gut-selective, anti-inflammatory monoclonal antibody, has shown preliminary efficacy in ulcerative colitis (UC) and Crohn's disease (CD). We report long-term experience with vedolizumab for active UC and CD.
Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study. [2022]This study aimed to compare real-world clinical effectiveness and safety of vedolizumab, an α4β7-integrin inhibitor, and anti-tumour necrosis factor-α [anti-TNFα] agents in biologic-naïve ulcerative colitis [UC] and Crohn's disease [CD] patients.
Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases. [2021]There are few real-world data on the safety of vedolizumab for treatment of Crohn's disease (CD) or ulcerative colitis (UC). We quantified rates and identified factors significantly associated with infectious and non-infectious adverse events in clinical practice.
Review of vedolizumab for the treatment of ulcerative colitis. [2020]The review summarises the key data on the efficacy and the safety of vedolizumab in the management of ulcerative colitis.
Vedolizumab: an α4β7 integrin inhibitor for inflammatory bowel diseases. [2018]To review the pharmacology, efficacy, and safety of vedolizumab in the treatment of patients with ulcerative colitis (UC) and Crohn's disease (CD).
Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme. [2022]Vedolizumab was shown to be effective and safe for patients with ulcerative colitis (UC) or Crohn's disease (CD) in the GEMINI phase 3 and long-term safety (LTS) studies.
Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn's disease - a systematic review with meta-analysis. [2023]The efficacy and safety of vedolizumab in bio-naïve patients with ulcerative colitis (UC) and Crohn's disease (CD) remain unknown.
Real-world outcomes of 54-week vedolizumab therapy and response durability after treatment discontinuation in ulcerative colitis: results from a multicenter prospective POLONEZ study. [2023]Vedolizumab is a gut-selective anti-lymphocyte trafficking agent used to treat ulcerative colitis (UC) and Crohn's disease.
Real-World Effectiveness of Vedolizumab Dose Escalation in Patients With Inflammatory Bowel Disease: A Systematic Literature Review. [2023]Vedolizumab is a gut-selective anti-lymphocyte trafficking agent approved for the treatment of moderate to severely active inflammatory bowel disease (IBD: ulcerative colitis [UC] and Crohn's disease [CD]).
Questions and answers about the management of Crohn's disease and ulcerative colitis with vedolizumab. [2020]Vedolizumab is an anti-integrin monoclonal antibody indicated for the treatment of patients with moderately to severely active Crohn's disease and ulcerative colitis who have failed conventional or anti-TNF therapies. The objective of this article is to answer a series of very practical questions regarding the management of both diseases with vedolizumab, based on data from published literature, as well as on the experience acquired by the authors in clinical practice in recent years.