Vedolizumab + Adalimumab/Ustekinumab for Crohn's Disease

This trial explores the effectiveness of a combination of medications for individuals with moderate to severe Crohn's disease, which causes inflammation in the digestive tract. Participants will initially receive a mix of vedolizumab (Entyvio) with either adalimumab (Humira) or ustekinumab (Stelara) to determine if these combinations can manage symptoms. Those who benefit will then continue with vedolizumab alone to maintain improvement. Ideal participants are those who have tried other treatments for Crohn's but found them ineffective or intolerable. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, with research helping to understand how it benefits more patients.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that vedolizumab, adalimumab, and ustekinumab are generally safe for treating Crohn's Disease. Vedolizumab has demonstrated a strong safety record across various studies, with some patients experiencing minor reactions at the injection site. Long-term use of vedolizumab has been positive for many patients, with few serious side effects reported.

When combined with adalimumab, studies indicate that this treatment is effective and maintains a good safety record. Some patients have reported mild side effects, which are usually easy to manage.

Similarly, combining vedolizumab with ustekinumab yields similar safety results. Research indicates both drugs generally have a low rate of serious side effects. Ustekinumab users reported a few adverse events, but these were not significantly different from those seen with vedolizumab.

Unlike the standard treatments for Crohn's Disease, which often rely on single biologic agents, the investigational approach of combining Vedolizumab with either Adalimumab or Ustekinumab offers a novel synergy. Vedolizumab specifically targets the gut, potentially minimizing systemic side effects, while Adalimumab and Ustekinumab work through different immune pathways, offering a multi-faceted attack on inflammation. This combination therapy could provide enhanced efficacy for patients who do not respond adequately to conventional single-agent therapies. Researchers are hopeful that this dual-targeted approach will lead to better disease control and improved quality of life for patients.

Research shows that vedolizumab effectively treats Crohn's disease. One study found that 48% of people taking vedolizumab were symptom-free after one year. In this trial, participants in Part A, Cohort 1 will receive a combination of vedolizumab and adalimumab, which previous studies have shown resulted in 54.5% of patients being symptom-free after 26 weeks. Meanwhile, participants in Part A, Cohort 2 will receive a combination of vedolizumab and ustekinumab, which also seems promising for people with more difficult cases of Crohn's disease. These findings suggest that these treatments can help manage symptoms and improve the quality of life for those with moderate to severe Crohn's disease.⁴⁶⁷⁸⁹