Vedolizumab for Ulcerative Colitis and Crohn's Disease

(PANORAMA Trial)

Recruiting at 43 trial locations

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Takeda

Must not be taking: Anti-integrin antibodies

Disqualifiers: Active infection, Ileostomy, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 50 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Vedolizumab, a treatment for individuals with ulcerative colitis (UC) or Crohn's disease (CD), which are chronic gut conditions causing symptoms like diarrhea and abdominal pain. The main goal is to determine how many participants experience symptom reduction after 3.5 months of treatment. Participants will initially receive the treatment intravenously for 6 weeks, then switch to subcutaneous injections for up to a year. This trial suits individuals with moderate to severe UC or CD who haven't found success with other treatments like corticosteroids or immunomodulators. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

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, you cannot use corticosteroid enemas or suppositories within 2 weeks before screening, and you should not have received certain advanced treatments recently. It's best to discuss your current medications with the trial team.

What is the safety track record for Vedolizumab?

Research has shown that Vedolizumab is generally safe for people with ulcerative colitis (UC) and Crohn's disease (CD). Studies have found that serious infections and reactions during infusions are rare. Infections occurred at a rate of 0.85 per patient-year, compared to 0.7 for those taking a placebo. Most side effects were mild.

Vedolizumab is already approved for treating moderate to severe UC and CD, indicating it is usually well-tolerated. No new safety issues have emerged, and any risks can be managed by following guidelines. Overall, Vedolizumab appears to be a safe treatment option for UC and CD. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Vedolizumab is unique because it specifically targets the gut, reducing inflammation in people with ulcerative colitis and Crohn's disease. Unlike traditional treatments that broadly suppress the immune system, vedolizumab works by blocking the migration of white blood cells into the gut, which means fewer side effects related to overall immune suppression. Researchers are excited about this treatment because it offers a targeted approach that could lead to better control of symptoms with a potentially improved safety profile, especially for long-term use. Additionally, the option to switch from intravenous to subcutaneous administration provides flexibility and convenience for patients.

What is the effectiveness track record for Vedolizumab in treating Ulcerative Colitis and Crohn's Disease?

Research shows that Vedolizumab effectively treats both ulcerative colitis (UC) and Crohn's disease (CD). In this trial, participants with UC will receive Vedolizumab. Studies indicate that about 62% of UC patients feel better after 54 weeks of treatment. One study found that 42% of UC patients had no symptoms at Week 52. For CD, participants in this trial will also receive Vedolizumab, and about 48% of CD patients were symptom-free when they received Vedolizumab every two weeks. Additionally, Vedolizumab has been shown to maintain its effectiveness over time and improve the quality of life for CD patients. Overall, Vedolizumab is a promising treatment option for both 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?

Adults aged 18-80 with Ulcerative Colitis or Crohn's Disease can join this trial. They must be up-to-date on immunizations, understand the study requirements, and agree to use effective contraception. Pregnant women, breastfeeding mothers, and those planning to donate sperm or ova during the study and for 18 weeks after cannot participate.

Inclusion Criteria

I have signed the consent form and any privacy documents for the study.

I agree not to donate eggs during and for 18 weeks after the study.

I understand and can follow the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Vedolizumab intravenously for the first 6 weeks, followed by subcutaneous injections every 2 weeks until Week 50

50 weeks

Several visits throughout the treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vedolizumab

Trial Overview The trial is testing Vedolizumab's ability to induce remission in UC and CD patients over a year. Initially given intravenously for six weeks, then as a subcutaneous injection until week 50. Effectiveness is assessed at week 14; non-responders switch treatments.

How Is the Trial Designed?

Group I: UC Participants: Vedolizumab Experimental Treatment 2 Interventions

Participants with moderate to severely active UC will receive vedolizumab 300 milligrams (mg), intravenous (IV) infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg subcutaneous (SC) injection at Week 6, to be administered every 2 weeks until Week 50. Treating health care practitioner (HCP) may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.

Group II: CD Participants: Vedolizumab Experimental Treatment 2 Interventions

Participants with moderate to severely active CD will receive vedolizumab 300 mg, IV infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg SC injection at Week 6, to be administered every 2 weeks until Week 50. Treating HCP may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.

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 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]

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 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]

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 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 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]

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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39102457/

Real-world Clinical Effectiveness and Safety of ... Biologic-naive patients with CD treated with vedolizumab demonstrated a greater likelihood of drug persistence and achieving clinical remission.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11580093/

Effectiveness and safety outcomes after long-term (54 ... Overall, VDZ effectively reduced CD symptoms and improved the patients' quality of life while showing clinical effectiveness and a safety ...

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. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ueg2.12705

Effectiveness and Treatment Persistence of Vedolizumab ... The analysis demonstrated that, overall, over one-third of patients achieved mucosal healing at 1 year and half of biologic-naive patients ...

5. academic.oup.com academic.oup.com/ibdjournal/article/31/8/2269/8161585

A Guide to the Patient-Centric Use of Vedolizumab for Crohn's ... In patients who received vedolizumab 108 mg every 2 weeks SC from week 6 (n = 275), 48.0% were in clinical remission (primary endpoint; CDAI ≤ ...

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

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

7. entyviohcp.com entyviohcp.com/safety-profile

Safety Profile for ENTYVIO® (vedolizumab) Proven safety profile based on 4 clinical trials · INFECTIONS. Infection rates with ENTYVIO were 0.85 per patient-year vs 0.7 for placebo · SERIOUS INFECTIONS.

8. 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.

9. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/entyvio

Entyvio | European Medicines Agency (EMA) Entyvio was also shown to be more effective than placebo at improving symptoms of Crohn's disease. In one main study in adult patients with moderate to severe ...

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

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