Table of contents

• Trial overview
• Conditions and patient groups
• What the trials measure
• Studies comparing Vedolizumab with other treatments
• Pediatric and long-term studies
• Special study designs and research questions

Trial overview

The trial data show many interventional studies, which means researchers assign a treatment and then watch what happens. Most studies are Phase 3, so they are testing how well Vedolizumab works in larger groups of patients and comparing it with other care options.^[1][2]

There is also one Phase 2 study and one low-intervention study, which means the trial follows routine care more closely and adds less extra study-related treatment.^[3][4]

Conditions and patient groups

Most trials focus on ulcerative colitis and Crohn’s disease, which are long-term inflammatory bowel diseases that affect the digestive tract.^[1][5]

Some studies include people with active chronic pouchitis, inflammatory bowel disease in remission, or people who are recovering after bowel surgery and have a risk of the disease coming back.^[6][7][8]

The trials include both adults and pediatric patients (children and teenagers). Several studies are designed for children or teenagers with active ulcerative colitis or Crohn’s disease, and some look at long-term treatment in this age group.^[6][9][10]

What the trials measure

The main study goals are usually clinical remission, endoscopic response, relapse rate, or safety. Clinical remission means symptoms are low or absent, while endoscopic response means the bowel looks better during a scope test.^[1][11]

Some trials use detailed scores such as the Mayo score, modified Mayo score, CDAI, PCDAI, SES-CD, mPDAI, and fecal calprotectin. These are tools that help doctors and researchers measure symptoms, bowel healing, and inflammation in a more exact way.^[1][3][12]

Several studies also measure steroid-free remission, which means a patient stays in remission without needing steroid medicine, and some studies measure safety events such as adverse events, serious adverse events, serious infections, malignancies, and other special safety concerns.^[4][7][10]

Studies comparing Vedolizumab with other treatments

Many trials compare Vedolizumab with another medicine or with a different treatment plan. One study compares it with risankizumab in adults with moderate to severe ulcerative colitis who have not used targeted therapy before.^[1]

Other studies compare Vedolizumab with adalimumab, infliximab, tofacitinib, or biosimilar products, and some trials test whether combination treatment works better than one medicine alone.^{[5][8][13][14]}

In ulcerative colitis, one trial looks at whether starting treatment with Vedolizumab, ustekinumab, filgotinib, or infliximab can help keep remission for a long time. Another study checks whether Vedolizumab is similar in effect to a proposed biosimilar product called AVT16.^[15][16]

Pediatric and long-term studies

Several trials focus on long-term treatment in children and teenagers with ulcerative colitis or Crohn’s disease. These studies look at both effectiveness and safety over time, including events like infections, bowel surgery, growth delay, and pubertal development delay.^[9][10]

One pediatric ulcerative colitis study measures clinical remission at Week 54, and a pediatric Crohn’s disease study measures both clinical remission and endoscopic response at Week 54. Another pediatric study measures Vedolizumab blood levels at steady state, which means after the treatment has reached a stable level in the body.^[11][12][17]

A long-term extension study also follows children with ulcerative colitis or Crohn’s disease who receive subcutaneous Vedolizumab, with safety as the main focus.^[9]

Special study designs and research questions

Some studies ask special questions beyond simple symptom control. For example, one trial studies whether therapeutic drug monitoring, which means checking drug levels to guide care, can help with dose de-escalation and cost-effectiveness in inflammatory bowel disease.^[18][19]

Another study looks at whether fecal microbiota transplantation, often called FMT, changes outcomes when given with Vedolizumab or infliximab. FMT means transferring stool bacteria from a donor to help change the gut microbiome, which is the community of germs living in the bowel.^[7]

One Crohn’s disease study looks at postoperative recurrence after ileocolonic resection, which is bowel surgery that removes part of the small bowel and colon and reconnects the ends. Another study examines whether treating bowel wall healing as a target is better than using a simpler treatment target in active Crohn’s disease.^[8][20]

There is also a study that compares the effect of anti-TNF treatment, Vedolizumab, and tofacitinib on carotid intima-media thickness, which is a measurement used to look at blood vessel thickness and cardiovascular risk.^[21]

References

[1] NCT06227910. A Study to Compare the Efficacy and Safety of Vedolizumab With and Without Upadacitinib in Adults With Moderately to Severely Active Crohn’s Disease (VICTRIVA).

[2] 2024-518998-33-00. A Study to Compare Risankizumab to Vedolizumab in Adult Subjects With Moderate to Severe Ulcerative Colitis.

[3] 2024-520201-39-00. A Phase 2a Study of the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Moderately to Severely Active Ulcerative Colitis.

[4] 2024-514740-82-00. SIMBA.

[5] 2023-506626-37-00. Evaluation of the efficacy and safety of dual biological therapy in patients with refractory Crohn’s disease resistant to induction (FLAMING).

[6] 2023-504773-20-00. Efficacy and Safety of Vedolizumab Intravenous in Pediatric Chronic Pouchitis.

[7] 2024-520373-12-00. Fecal microbiota transplantation in patients receiving infliximab and vedolizumab for ulcerative colitis: A randomized controlled trial.

[8] NCT05169593. Prevention of postoperative endoscopic disease recurrence in Crohn’s disease.

[9] NCT06405087. Vedolizumab Subcutaneous Long-term Open-label Extension Study in Pediatric Subjects.

[10] NCT05442567. A Long-term Study in Children and Teenagers with Ulcerative Colitis or Crohn’s Disease treated with Vedolizumab IV.

[11] NCT04779307. A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC).

[12] NCT04779320. A study of Vedulizumab in Children and Teenagers with Moderate to Severe Crohn’s Disease (CD).

[13] NCT06180382. Comparison of Vedolizumab treatment to Adalimumab dose intensification in Crohn’s disease patients with loss of response or biomarker activity to Adalimumab.

[14] 2022-502778-18-00. A study in people with moderately to severely active ulcerative colitis to see how well an investigational treatment called PB016 works and how safe it is compared to a licensed treatment called Entyvio®.

[15] NCT04259138. VERDICT – Optimal Treatment Target in Active Ulcerative Colitis (UC).

[16] 2024-514964-24-00. FirST lines of biologics in pAtients with ulceRaTivE colitis: a Randomised controlled trial.

[17] NCT06100289. Phase 3 Study of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease.

[18] NCT20220008. SILVER-study.

[19] 2024-517123-39-00. MOVE-IT.

[20] 2024-520373-12-00. Fecal microbiota transplantation in patients receiving infliximab and vedolizumab for ulcerative colitis: A randomized controlled trial.

[21] NCT06257706. A Study to Evaluate Whether Healing all Bowel Wall Layers is a Superior Treatment Target in Patients with Active Crohn’s Disease (CD).

[22] 2024-517314-15-00. IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS.