VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease

Part of paid clinical trials in Los Angeles, California.

Sponsor
Alimentiv Inc.
Study ID
NCT06257706
Phase
PHASE4
Status
Recruiting
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Conditions

  • Crohn Disease
  • Disease Crohn
  • Moderately to Severely Active Crohn's Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Vedolizumab — BIOLOGICAL
    All participants will begin a vedolizumab induction regimen of 300 mg IV at Weeks 0, 2, 6, and 10 followed by vedolizumab 300 mg IV every 8 weeks starting at Week 14. Treatment may be modified at Weeks 22, 30, and/or 38 based on the results of the target assessment at each of these time points.

Study Details

Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a patient-friendly technique that can be performed routinely in clinical practice. The aim of the study is to determine if treating to a target of corticosteroid-free (CS-free) IUS outcomes + clinical symptoms + biomarkers is superior to a target of clinical symptoms + biomarkers alone in achieving CS-free endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). Qualified participants will be randomly assigned in a 1:1 ratio to one of 2 different target treatment groups. Group 1: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. At Week 22 and 30, the IUS-based component of the target will be IUS response and at Week 38, the final treatment target will be TMH. Group 2: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.

Key Dates

Start date
Aug 7, 2024
Status verified
Jan 2026
Primary completion
Jan 3, 2029
Completion
Feb 6, 2029

Study Design

Enrollment
304 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Group 1: Corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission
    Group 1 will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. At Week 22 and 30, the IUS-based component of the target will be IUS response and at Week 38, the final treatment target will be TMH.
  • Other: Group 2: Corticosteroid-free clinical remission + biomarker remission.
    Group 2 will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.

Primary Outcome Measure

Percentage of participants with Corticosteroid-free Endoscopic remission in group 1 and group 2 at week 48 [ Time Frame: week 48 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
TLC Clinical Research Inc - Los AngelesLos AngelesCalifornia90048-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425
Erin Forster, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Bincy Abraham, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
TLC Clinical Research Inc - Los Angeles· Los Angeles, CAMedical University of South Carolina (MUSC)· Charleston, SCHouston Methodist Hospital· Houston, TX

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