121 Participants Needed

Vedolizumab for Ulcerative Colitis

Recruiting at 138 trial locations
TS
TC
Overseen ByTakeda Contact
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be unresponsive or intolerant to their current standard of care, which might imply changes to your medication routine. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the drug Vedolizumab for treating ulcerative colitis?

Vedolizumab has been shown to be effective for treating moderate to severe ulcerative colitis, with clinical trials indicating higher rates of clinical response and remission compared to a placebo. It is specifically designed to target inflammation in the gut, making it a useful option for patients who have not responded well to other treatments.12345

Is Vedolizumab safe for humans?

Vedolizumab (Entyvio) has been shown to be a safe treatment for inflammatory bowel diseases like Crohn's disease and ulcerative colitis, with a low frequency of serious infections reported in clinical trials and real-world use.12356

How does the drug Vedolizumab differ from other treatments for ulcerative colitis?

Vedolizumab is unique because it specifically targets the α4β7 integrin, which helps prevent immune cells from reaching the gut and causing inflammation, making it gut-specific and reducing the risk of certain side effects seen with other treatments. This mechanism is different from other drugs like anti-TNF agents, which can affect the entire immune system.12345

Eligibility Criteria

This trial is for children and teenagers weighing at least 10 kg with moderate to severe ulcerative colitis diagnosed over a month ago. They must have tried treatments like corticosteroids or TNF-α antagonists without success, or cannot tolerate them. Participants should not have had certain surgeries, live vaccines recently, other biologic treatments too close to the study start, active infections including TB or hepatitis B/C, or any history of neurological disorders.

Inclusion Criteria

My ulcerative colitis is active and not responding to current treatments.
My ulcerative colitis extends beyond the rectum.
My previous treatments for my condition, including steroids or immunomodulators, have not worked or caused side effects.
See 4 more

Exclusion Criteria

I haven't had a serious infection like pneumonia or COVID-19 in the last 30 days.
I haven't taken any experimental or approved biologic drugs recently.
I have had surgery to remove all or part of my colon, or I have a stoma or known narrow section in my intestine.
See 12 more

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 at Baseline

6 weeks
3 visits (in-person)

Maintenance

Participants who achieve clinical response receive vedolizumab IV infusions every 8 weeks up to Week 46

32 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks
1 visit (in-person or virtual)

Long-term follow-up

Participants enter an observational long-term follow-up period of 2 years after the last dose of study drug

104 weeks
Every 6 months (in-person or phone call)

Treatment Details

Interventions

  • Vedolizumab
Trial OverviewThe trial tests Vedolizumab's effectiveness in achieving remission from ulcerative colitis symptoms in young patients. Remission is when symptoms improve greatly or disappear and an endoscopy shows little to no disease signs. Initially, participants get three infusions over six weeks; responders continue with one of three doses every eight weeks.
Participant Groups
9Treatment groups
Experimental Treatment
Group I: Maintenance Period: Participants ≥30 kg, Vedolizumab 300 mgExperimental Treatment1 Intervention
Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.
Group II: Maintenance Period: Participants ≥30 kg, Vedolizumab 150 mgExperimental Treatment1 Intervention
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.
Group III: Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mgExperimental Treatment1 Intervention
Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of \>15 to \<30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.
Group IV: Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mgExperimental Treatment1 Intervention
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of \>15 to \<30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Group V: Maintenance Period: Participants 10 to 15 kg, Vedolizumab 150 mgExperimental Treatment1 Intervention
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.
Group VI: Maintenance Period: Participants 10 to 15 kg, Vedolizumab 100 mgExperimental Treatment1 Intervention
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Group VII: Induction Period: Participants ≥30 kg, Vedolizumab 300 mgExperimental Treatment1 Intervention
Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of ≥30 kg are included in this arm.
Group VIII: Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mgExperimental Treatment1 Intervention
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of \>15 to \<30 kg are included in this arm.
Group IX: Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mgExperimental Treatment1 Intervention
Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg are included in this arm.

Vedolizumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Entyvio for:
  • Ulcerative colitis
  • Crohn's disease
🇺🇸
Approved in United States as Entyvio for:
  • Ulcerative colitis
  • Crohn's disease
🇨🇦
Approved in Canada as Entyvio for:
  • Ulcerative colitis
  • Crohn's disease
🇯🇵
Approved in Japan as Entyvio for:
  • Ulcerative colitis
  • Crohn's disease

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 Université de Montpellier

Findings from Research

Vedolizumab is a humanized monoclonal antibody that targets the α4β7 integrin receptor, specifically designed for treating moderate-to-severe ulcerative colitis and Crohn's disease in adults who have not responded well to standard therapies.
It has received global approval, including in the US and EU, for patients who have had inadequate responses to other treatments, highlighting its role as an important option for those with difficult-to-treat inflammatory bowel diseases.
Vedolizumab: first global approval.Poole, RM.[2021]
Vedolizumab is a monoclonal antibody that effectively targets the α4β7 integrin to inhibit gut lymphocyte trafficking, providing a safe treatment option for patients with moderate to severe Crohn's disease and ulcerative colitis.
Unlike anti-TNF agents, which some patients may become intolerant to or lose response over time, vedolizumab offers a promising alternative for those who are primary nonresponders or have developed antidrug antibodies.
Vedolizumab as a Treatment for Crohn's Disease and Ulcerative Colitis.Ha, C., Kornbluth, A.[2022]
Vedolizumab is an effective treatment for moderate-to-severe inflammatory bowel diseases like Crohn's disease and ulcerative colitis, with a well-established safety profile based on extensive clinical trial data and real-world studies.
The safety data indicates no unexpected long-term risks, making vedolizumab a strong candidate for combination therapies in patients with complex or refractory cases of inflammatory bowel disease.
An update on the safety of long-term vedolizumab use in inflammatory bowel disease.Honap, S., Netter, P., Danese, S., et al.[2023]

References

Vedolizumab: first global approval. [2021]
Vedolizumab as a Treatment for Crohn's Disease and Ulcerative Colitis. [2022]
An update on the safety of long-term vedolizumab use in inflammatory bowel disease. [2023]
Vedolizumab: a review of its use in adult patients with moderately to severely active ulcerative colitis or Crohn's disease. [2016]
Low Frequency of Opportunistic Infections in Patients Receiving Vedolizumab in Clinical Trials and Post-Marketing Setting. [2023]
Influence of Drug Exposure on Vedolizumab-Induced Endoscopic Remission in Anti-Tumour Necrosis Factor [TNF] Naïve and Anti-TNF Exposed IBD Patients. [2021]