Vedolizumab for Ulcerative Colitis and Crohn's Disease

Recruiting at 89 trial locations

Overseen By Takeda Contact

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Takeda

Must not be taking: Anti-integrins, MAdCAM-1 antagonists

Disqualifiers: Neurological disorders, Tuberculosis, Hepatitis B, 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

Compensation: Varies

Number of Visits: 9

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how children and teenagers with ulcerative colitis or Crohn's disease respond to vedolizumab, administered through injections under the skin. The study aims to understand how the body processes this medicine in those with moderate to severe symptoms. Participants will receive the treatment over approximately 34 weeks, with dosages adjusted based on weight. Children and teens who have experienced these conditions for at least a month and have not responded well to other treatments may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment option.

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.

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

Research has shown that vedolizumab is generally safe for treating ulcerative colitis (UC) and Crohn’s disease (CD). Most side effects are mild and not serious. Although some patients experienced serious infections, these cases are rare. Real-world evidence suggests that vedolizumab causes fewer serious infections than some other treatments. Overall, current data considers vedolizumab well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for ulcerative colitis and Crohn's disease?

Vedolizumab is unique because it specifically targets the gut, which is different from many existing treatments for ulcerative colitis and Crohn's disease that affect the entire immune system. Most treatments for these conditions involve corticosteroids or immunosuppressants that can have wide-ranging side effects. Vedolizumab works by blocking a protein that directs white blood cells to the gut, reducing inflammation directly where it matters most. Researchers are excited about this targeted approach because it promises effective treatment with potentially fewer side effects, offering a more focused solution for patients.

What evidence suggests that vedolizumab might be an effective treatment for ulcerative colitis and Crohn's disease?

Research shows that vedolizumab effectively treats ulcerative colitis (UC) and Crohn's disease (CD). Studies have found that many patients using vedolizumab experienced symptom improvement or remission. For example, one study found that 32% of UC patients achieved remission just two weeks after starting treatment, with up to 55% reaching remission by 14 weeks. Another study demonstrated that vedolizumab helped CD patients maintain their health after initially responding to treatment. This trial will evaluate different dosing regimens of vedolizumab based on participant weight to further understand its effectiveness. Overall, vedolizumab has significantly helped people with these conditions. ^{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 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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Vedolizumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Maintenance Period: Participants ≥30 kg, Vedolizumab 108 mg SC Q2W Experimental Treatment 1 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 Q4W Experimental Treatment 1 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) IV Experimental Treatment 1 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) IV Experimental Treatment 1 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) IV Experimental Treatment 1 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.

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

In a study of 1087 patients with Crohn's disease and ulcerative colitis, vedolizumab demonstrated a favorable safety profile, with a low overall infection rate of 6.3% and non-infectious adverse events primarily being arthralgias (2.9%).

Factors such as active smoking and the use of multiple immunosuppressive agents were found to significantly increase the risk of infections in patients receiving vedolizumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases. Meserve, J., Aniwan, S., Koliani-Pace, JL., et al.[2021]

In a study of 1095 biologic-naïve patients with ulcerative colitis (UC) and Crohn's disease (CD) over 24 months, vedolizumab and anti-TNFα agents showed similar effectiveness in managing disease symptoms.

However, vedolizumab was associated with significantly lower rates of serious adverse events and serious infections, indicating a more favorable safety profile compared to anti-TNFα treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study. Bressler, B., Yarur, A., Silverberg, MS., et al.[2022]

In a systematic review of 10 real-world studies involving 395 patients with inflammatory bowel disease (IBD), approximately 50% achieved a clinical response after escalating vedolizumab maintenance dosing from every 8 weeks to every 4 weeks.

Clinical response rates varied between 40% to 73% across the studies, indicating that dose escalation can be an effective strategy for patients experiencing secondary loss of response or non-response to vedolizumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Effectiveness of Vedolizumab Dose Escalation in Patients With Inflammatory Bowel Disease: A Systematic Literature Review. Patel, D., Martin, S., Luo, M., et al.[2023]

In a real-world study of 132 patients with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC), vedolizumab showed sustained clinical response, with 35% of UC patients and 31% of CD patients achieving steroid-free remission after 12 months.

Mucosal healing was observed in 52% of UC patients and 30% of CD patients, indicating that vedolizumab is effective in promoting healing in the intestines, with most adverse events being minor and 74% of patients continuing treatment after one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vedolizumab as Induction and Maintenance for Inflammatory Bowel Disease: 12-month Effectiveness and Safety. Christensen, B., Colman, RJ., Micic, D., et al.[2020]

In a study of 53 patients with ulcerative colitis and Crohn's disease receiving vedolizumab therapy, 20% of ulcerative colitis patients and 14.3% of Crohn's disease patients achieved remission by week 30, indicating some efficacy in a treatment-refractory population.

Despite some patients responding to vedolizumab, a significant portion (48% for ulcerative colitis and 39.4% for Crohn's disease) did not respond satisfactorily, highlighting the need for alternative treatment options for those not achieving remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Outcomes of Vedolizumab Therapy in Ulcerative Colitis and Crohn's Disease at a Tertiary Referral Center. Hoffmann, P., Krisam, J., Stremmel, W., et al.[2018]

Vedolizumab has been shown to be effective in managing ulcerative colitis, providing significant improvements in patient symptoms and disease control.

The review also highlights that vedolizumab has a favorable safety profile, making it a suitable treatment option for patients with ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of vedolizumab for the treatment of ulcerative colitis. Lau, MS., Tsai, HH.[2020]

Vedolizumab is an effective treatment for moderate to severe ulcerative colitis (UC) and Crohn's disease (CD), helping to induce and maintain clinical response and remission, as shown in multiple phase trials.

The drug is generally well tolerated, with common side effects including nasopharyngitis and headache, but it has not been linked to serious conditions like progressive multifocal leukoencephalopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vedolizumab: an α4β7 integrin inhibitor for inflammatory bowel diseases. Smith, MA., Mohammad, RA.[2018]

In a study involving 311 patients with ulcerative colitis (UC) and Crohn's disease (CD), vedolizumab demonstrated high treatment persistence, with 93.9% of UC patients and 91.6% of CD patients remaining on a reduced dosing schedule of every 8 weeks after 2 years.

The safety profile of vedolizumab remained consistent with previous studies, showing infrequent adverse events and low relapse rates of 9.1% for UC and 14.0% for CD among those who reduced their dosing frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme. Danese, S., Subramaniam, K., Van Zyl, J., et al.[2022]

In a study of 258 inflammatory bowel disease patients on maintenance vedolizumab, those in clinical and biochemical remission had significantly higher drug concentrations (12.7 µg/mL) compared to those with active disease (10.1 µg/mL), indicating a strong association between higher vedolizumab levels and remission.

Patients with vedolizumab concentrations above 11.5 µg/mL were nearly 2.4 times more likely to achieve corticosteroid-free clinical and biochemical remission, suggesting that maintaining adequate drug levels is crucial for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher Trough Vedolizumab Concentrations During Maintenance Therapy are Associated With Corticosteroid-Free Remission in Inflammatory Bowel Disease. Ungaro, RC., Yarur, A., Jossen, J., et al.[2020]

In a long-term study involving 72 patients with ulcerative colitis (UC) and Crohn's disease (CD), vedolizumab demonstrated significant clinical efficacy, with 39% of patients achieving a clinical response and 58.3% achieving clinical remission after treatment.

Vedolizumab was well-tolerated over the treatment period of up to 78 weeks, with no deaths or serious infections reported, indicating a favorable safety profile similar to previous studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term clinical experience with vedolizumab in patients with inflammatory bowel disease. Parikh, A., Fox, I., Leach, T., et al.[2022]

In a study of 100 patients with moderate to severe ulcerative colitis, vedolizumab demonstrated effectiveness with a clinical response in 62% and clinical remission in 50% after 54 weeks of treatment, indicating it is a viable option for managing this condition.

Despite its effectiveness, 37% of patients who responded to treatment experienced a relapse within 26 weeks after discontinuation, highlighting the need for ongoing monitoring and potential additional therapies after stopping vedolizumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world outcomes of 54-week vedolizumab therapy and response durability after treatment discontinuation in ulcerative colitis: results from a multicenter prospective POLONEZ study. Eder, P., Kłopocka, M., Cichoż-Lach, H., et al.[2023]

Vedolizumab demonstrated significant efficacy in bio-naïve patients with ulcerative colitis (UC) and Crohn's disease (CD), with 63.9% of UC patients and 61.7% of CD patients achieving clinical remission by week 52.

Bio-naïve patients with UC experienced a lower risk of serious adverse events compared to those previously treated, indicating a favorable safety profile for vedolizumab in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn's disease - a systematic review with meta-analysis. Attauabi, M., Madsen, GR., Bendtsen, F., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8797168/

Efficacy and Safety of Subcutaneous Vedolizumab in Patients ... Vedolizumab SC is an effective and safe maintenance therapy in patients with CD who responded to two infusions of vedolizumab intravenous induction therapy.

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

Ulcerative Colitis Clinical Trials for ENTYVIO® (vedolizumab) GEMINI I trial data: 42% of patients achieved clinical remission at Week 52 with. ENTYVIO IV. Placebo. CI=confidence interval; Q8W=every 8 weeks.

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2025/761359Orig1s000MultidisciplineR.pdf

761359Orig1s000 - accessdata.fda.gov to receive either vedolizumab SC 108 mg Q2W or 108 mg QW. Pharmacokinetics of Vedolizumab in Subjects With CD. The observed PK of vedolizumab ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02620046

NCT02620046 | A Study of Long-term Effects ... The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative ...

5. gastrojournal.org gastrojournal.org/article/S0016-5085(19)41247-X/fulltext

Efficacy and Safety of Vedolizumab Subcutaneous ... In conclusion, the new vedolizumab SC formulation, administered at 108 mg every 2 weeks, was effective and generally safe as maintenance therapy ...

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. entyviohcp.com entyviohcp.com/safety-profile

Safety Profile for ENTYVIO® (vedolizumab) Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria ...

8. gut.bmj.com gut.bmj.com/content/66/5/839

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

9. takeda.com takeda.com/en-ca/newsroom/2018/entyvio-real-world-safety-data/

Analysis of real-world safety data shows gut-selective ... Analysis of real-world safety data shows gut-selective ENTYVIO® (vedolizumab) had fewer serious infections and adverse events than those on ...

10. entyvio.com entyvio.com/

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