Dual Targeted Therapy in Moderate to Severe Crohn's Disease

What is the Purpose of this Study?

The purpose of this study is to determine whether combining approved treatments (dual therapy) for Crohn’s disease is safe and improves patient outcomes. The treatment combinations referred to as “dual targeted therapy” are vedolizumab given by intravenous (IV) infusion plus adalimumab given by subcutaneous (SC- under the skin) injection, or vedolizumab given by IV infusion plus ustekinumab given by IV infusion for the first dose and SC injection for the rest of the doses. Treatment will consist of a 26-week dual therapy period and then, for some participants, a 26 week vedolizumab monotherapy (single therapy) treatment period. Study visits will consist of physical exams, laboratory tests, endoscopies, and completion of questionnaires. The combined use of vedolizumab, with either adalimumab or ustekinumab, as dual targeted therapy for the treatment of Crohn's disease is investigational.


Eligibility

  • Part A:
  • 1. Has a confirmed diagnosis of CD at least 3 months before baseline, based on endoscopy results.
  • 2. Has moderately to severely active CD at Screening, defined as a CDAI score ≥220 and a SES-CD ≥6 (≥4 if isolated ileal disease).
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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

Study Details
Disease Type/Condition

Other

Principal Investigator

Yarur, Andres

Co-Investigators

Andrea Banty, Gil Melmed, Susie Lee, Teddy Solomon

Age Group

Adult

Phase

IV

IRB Number

STUDY00002820

ClinicalTrials.gov ID

NCT06045754

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Yarur, Andres

Age Group

Adult

Phase

IV

IRB Number

VEDOLIZUMAB-4051

ClinicalTrials.gov ID

NCT06045754

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org