Vedolizumab for Ulcerative Colitis and Crohn's Disease

Recruiting at 81 trial locations

Overseen By Maria Oliva-Hemker

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Takeda

Must be taking: Vedolizumab

Disqualifiers: Surgery, Cardiovascular, Pregnancy, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 27

Duration: Up to 5 years

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to ensure the long-term safety of vedolizumab, a treatment for children with ulcerative colitis (UC) or Crohn's disease (CD). Participants who completed a previous related study and avoided steroids for at least 12 weeks can join. The trial involves regular IV infusions of vedolizumab (also known as Entyvio) to observe its effects over time. Those who left the earlier study early or finished but didn't qualify for the treatment part may still join an observational group. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new 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. 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that vedolizumab, a treatment for Crohn's disease and ulcerative colitis, is generally safe. In past studies, most side effects were mild and not serious. Some people experienced minor reactions at the injection site, but these were usually not worrisome.

Long-term data indicates that vedolizumab is well-tolerated, with few serious infections or major health problems. It has been safely used in over 3,300 adults with Crohn's disease and ulcerative colitis. Additionally, the FDA has approved vedolizumab for these conditions, supporting its safety.

Overall, evidence suggests that vedolizumab is a safe choice for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Vedolizumab is unique because it specifically targets the gut, which is a big deal for treating Ulcerative Colitis and Crohn's Disease. Unlike traditional treatments like corticosteroids and immunosuppressants that affect the entire immune system, vedolizumab works by blocking a protein called integrin, which helps immune cells move into the gut. This targeted approach can mean fewer side effects and a better quality of life for patients. Researchers are excited about vedolizumab because it offers a promising alternative that could be safer and more effective for long-term management.

What evidence suggests that vedolizumab is effective for ulcerative colitis and Crohn's disease?

Research has shown that vedolizumab effectively treats inflammatory bowel diseases like ulcerative colitis and Crohn's disease. One study found that 52% of ulcerative colitis patients improved with treatment, and 34% were symptom-free by week 12. For Crohn's disease, 27% of patients improved, and 47% were symptom-free. Another study found that many ulcerative colitis patients were symptom-free by week 52, with some not needing steroids. Overall, vedolizumab has proven effective in helping patients achieve symptom relief in these conditions. Participants in this trial will receive different dosages of vedolizumab based on their weight, as part of the various treatment arms. ^{6 7 8 9 10}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

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

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.

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

Exclusion Criteria

Participant is lactating or pregnant.

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

Participant is unable to comply with all study assessments

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Vedolizumab IV

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.

How Is the Trial Designed?

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.

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

Approved in European Union as Entyvio for:

• Ulcerative colitis
• Crohn's disease

Approved in United States as Entyvio for:

• Moderately to severely active ulcerative colitis
• Moderately to severely active Crohn's disease

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

Published Research Related to This Trial

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 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]

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]

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, 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8255566/

Real-world effectiveness of vedolizumab in inflammatory ... At week 12, clinical response was 27% and remission 47% in Crohn's disease; corresponding figures in ulcerative colitis were 52% and 34%.

2. entyviohcp.com entyviohcp.com/ulcerative-colitis-efficacy

Ulcerative Colitis Clinical Trials for ENTYVIO® (vedolizumab) *Many patients taking ENTYVIO IV achieved remission at Week 52 vs placebo, some without steroids. Some achieved remission at Week 6.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1590865825007364

Vedolizumab in inflammatory bowel disease: Real-world ... Vedolizumab is effective and safe in IBD patients. XAI yielded promising results in identifying the most important predictors of SFCR and development of AEs.

4. gastroenterologyadvisor.com gastroenterologyadvisor.com/reports/vedolizumab-for-ulcerative-colitis-superior-to-infliximab-as-first-line-therapy/

Vedolizumab for Ulcerative Colitis May Be Superior to ... At week 52, vedolizumab and infliximab recipients exhibited clinical remission rates of 82.3% and 77.4% (P =.11), endoscopic remission rates of ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1215734

Vedolizumab as Induction and Maintenance Therapy for ... At week 52, this outcome was observed in 31.4% of the patients who received vedolizumab every 8 weeks and in 45.2% of those who received ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31504340/

The Safety Profile of Vedolizumab in Ulcerative Colitis and ... Adverse event patterns were consistent with clinical trials, with no new safety concerns. Most reported events were non-serious and event ...

7. entyvio.com entyvio.com/

ENTYVIO® (vedolizumab) for Crohn's Disease or Ulcerative ... ENTYVIO is a biologic treatment for moderate to severe Crohn's disease (CD) or ulcerative colitis (UC). See Safety and Prescribing Information.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00619489

Study Details | NCT00619489 | Long Term Safety of ... Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease. ClinicalTrials.gov ID NCT00619489. Sponsor Millennium ...

9. entyviohcp.com entyviohcp.com/safety-profile

Safety Profile for ENTYVIO® (vedolizumab) Up to 7 years of consistent results across safety parameters. 1-3 * Clinical trials evaluated safety in more than 3300 adults (UC, Crohn's, and healthy ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26893500/

The safety of vedolizumab for ulcerative colitis and Crohn's ... Vedolizumab has a favourable safety profile with low incidence rates of serious infections, infusion-related reactions and malignancies over an extended ...