Vedolizumab for Ulcerative Colitis and Crohn's Disease

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.

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.

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.¹²³⁴⁵

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.

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.⁶⁷⁸⁹¹⁰