An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy With Vedolizumab Intravenous (IV) and Adalimumab Subcutaneous (SC) or Vedolizumab IV and Ustekinumab IV/SC in Moderate to Severe Crohn's Disease (CD)

Summary

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.

Description

Eligibility

Age range

18–70 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Vedolizumab

  Vedolizumab intravenous infusion.

• Drug
  Adalimumab

  Adalimumab subcutaneous injection.

• Drug
  Ustekinumab

  Ustekinumab intravenous infusion.

• Drug
  Ustekinumab

  Ustekinumab subcutaneous injection.

Locations (54)