Vedolizumab for Ulcerative Colitis and Crohn's Disease

Recruiting in Palo Alto (17 mi)

+71 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Takeda

Must be taking: Vedolizumab

Disqualifiers: Surgery, Cardiovascular, Pregnancy, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, participants must have tapered off steroids at least 12 weeks before a certain point in the study, so discuss your current medications with the study team to be sure.

What data supports the effectiveness of the drug Vedolizumab for treating ulcerative colitis and Crohn's disease?

Vedolizumab has been shown to be effective in treating ulcerative colitis, with higher rates of clinical response and remission compared to placebo in clinical trials. For Crohn's disease, the results were mixed, but it was more effective than placebo in maintaining remission at 52 weeks. ^{1 2 3 4 5}

Is vedolizumab safe for humans?

Vedolizumab, used for treating Crohn's disease and ulcerative colitis, is generally considered safe based on clinical trials and real-world data. It is well tolerated and has a gut-specific action, reducing the risk of certain serious side effects seen with similar drugs. However, some adverse events have been reported, and longer-term studies are needed to fully understand its safety profile. ^{1 2 3 4 6}

How is the drug Vedolizumab different from other treatments for Crohn's disease and ulcerative colitis?

Vedolizumab is unique because it is a monoclonal antibody that specifically targets the α4β7 integrin, which helps control inflammation in the gut without affecting the rest of the body. This makes it different from other treatments like anti-TNF drugs, which can affect the entire immune system and may lead to more side effects. ^{1 2 3 7 8}

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

This trial is for children with Ulcerative Colitis or Crohn's Disease who completed previous studies MLN0002-3024 or MLN0002-3025 and responded well without steroids. Participants must agree to use effective contraception if they are sexually active.

Inclusion Criteria

I am a man who will use condoms if my partner can get pregnant.

For Treatment Cohort: Participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54, as defined by specific criteria

For Observational Cohort: Participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study.

Exclusion Criteria

I need or will likely need major surgery for my ulcerative colitis or Crohn's disease during the study.

Participant has other serious comorbidities that will limit their ability to complete the study

Participant is unable to comply with all study assessments

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive vedolizumab IV infusion every 8 weeks for up to approximately 5 years

Up to 5 years

Visits every 8 weeks for IV infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

Final safety/end of study visit 18 weeks after last dose

Observational Cohort

Participants who are not eligible for the Treatment Cohort are monitored for prespecified safety events

Up to 2 years

Assessment visits at Day 1 and Weeks 8, 34, 60, and 86

Treatment Details

Interventions

• Vedolizumab IV (Monoclonal Antibodies)

Trial Overview The study tests the long-term safety of Vedolizumab, a medication given through IV, in children. It extends two prior studies and continues to monitor those who previously received Vedolizumab.

Participant Groups

Group I: Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mg Experimental Treatment 1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 300 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group II: Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mg Experimental Treatment 1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group III: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mg Experimental Treatment 1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 200 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group IV: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mg Experimental Treatment 1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group V: Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mg Experimental Treatment 1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group VI: Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mg Experimental Treatment 1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group VII: Observational Cohort: Early Terminated Participants From Parent Studies Experimental Treatment 1 Intervention

Participants will have assessment visits at Day 1 and Weeks 8, 34, 60, and 86 as part of a long-term follow-up period to assess prespecified safety events of interest and to monitor growth and pubertal development for approximately 2 years after their last dose of study drug in parent study.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vedolizumab: first global approval. Poole, RM.[2021]

In phase III clinical trials, vedolizumab significantly improved clinical response and remission rates in patients with ulcerative colitis compared to placebo at both 6 and 52 weeks, demonstrating its efficacy for this condition.

While vedolizumab showed mixed results for Crohn's disease, it was effective in achieving clinical remission at 52 weeks in maintenance treatment, and it is generally well tolerated, with a lower risk of serious side effects compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vedolizumab: a review of its use in adult patients with moderately to severely active ulcerative colitis or Crohn's disease. Garnock-Jones, KP.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on the safety of long-term vedolizumab use in inflammatory bowel disease. Honap, S., Netter, P., Danese, S., et al.[2023]

Vedolizumab (Entyvio) is an effective treatment for ulcerative colitis and Crohn's disease, targeting the gut's immune response to reduce inflammation.

Dalbavancin (Dalvance) is used to treat acute bacterial skin infections, providing a long-acting option for patients, while antihemophilic factor, recombinant (Eloctate) is a key therapy for managing hemophilia A by replacing the missing clotting factor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmaceutical approval update. Goldenberg, MM.[2021]

Vedolizumab, a gut-selective integrin blocker for Crohn's disease and ulcerative colitis, showed a similar rate of serious adverse events (35.9%) compared to anti-TNF drugs (32.1%) in a study analyzing 499 reports for vedolizumab and 119,620 for anti-TNFs.

The study identified 22 groups of adverse events associated with vedolizumab, including 9 with serious outcomes, suggesting potential cardiovascular risks; however, these findings are preliminary and require further investigation through long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system. Cross, RK., Chiorean, M., Vekeman, F., et al.[2023]

In a study of 440 patients (180 with ulcerative colitis and 260 with Crohn's disease), vedolizumab demonstrated significant effectiveness, achieving 12-month clinical remission rates of 57.4% for ulcerative colitis and 58.4% for Crohn's disease.

The treatment was found to be safe, with a serious adverse event rate of 15.6 per 100 patient-years, indicating that vedolizumab can be a reliable option for managing inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world Effectiveness and Safety of Vedolizumab for the Treatment of Inflammatory Bowel Disease: The Scottish Vedolizumab Cohort. Plevris, N., Chuah, CS., Allen, RM., et al.[2020]

Vedolizumab is an effective treatment option for patients with moderately to severely active Crohn's disease and ulcerative colitis who have not responded to conventional therapies or anti-TNF treatments.

The article provides practical management insights for using vedolizumab, drawing from both published research and the authors' clinical experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Questions and answers about the management of Crohn's disease and ulcerative colitis with vedolizumab. Hinojosa Del Val, J., Barreiro-de Acosta, M.[2020]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Vedolizumab: first global approval. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Vedolizumab: a review of its use in adult patients with moderately to severely active ulcerative colitis or Crohn's disease. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Vedolizumab as a Treatment for Crohn's Disease and Ulcerative Colitis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

An update on the safety of long-term vedolizumab use in inflammatory bowel disease. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Pharmaceutical approval update. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Real-world Effectiveness and Safety of Vedolizumab for the Treatment of Inflammatory Bowel Disease: The Scottish Vedolizumab Cohort. [2020]

8. Spain pubmed.ncbi.nlm.nih.gov

Questions and answers about the management of Crohn's disease and ulcerative colitis with vedolizumab. [2020]