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Monoclonal Antibodies

Vedolizumab for Crohn's Disease (VECTORS Trial)

Phase 4

Recruiting

Led By Vipul Jairath, MD

Research Sponsored by Alimentiv Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderately-to-severely active Crohn's Disease at baseline defined by specific CDAI and SES-CD scores

BWT on IUS of >4.0 mm in the ileum or any colonic segment (excluding the rectum)

Must not have

Presence of certain gastrointestinal conditions

Previously exposed to 2 or more advanced therapeutic compounds

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial aims to study the effectiveness of treating Crohn's disease patients to a specific target using noninvasive intestinal ultrasound (IUS), clinical symptoms, and biomarkers. Participants will be randomly assigned

Who is the study for?

Adults aged 18-80 with moderately-to-severely active Crohn's Disease, evidenced by specific ultrasound and biomarker levels. Participants can be biologic-naïve or have limited prior treatment with advanced therapies for CD. They must not be pregnant and agree to use effective contraception.

What is being tested?

The trial is testing if targeting transmural healing using vedolizumab plus monitoring with intestinal ultrasound, clinical symptoms, and biomarkers leads to better outcomes than just targeting clinical symptoms and biomarkers without the ultrasound component.

What are the potential side effects?

Vedolizumab may cause side effects such as risk of infection, infusion-related reactions like headache or fever, potential liver issues, allergic reactions including rash or itching, joint pain, nausea or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Crohn's Disease is active and severe according to my test scores.

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My ultrasound shows thickening in my ileum or colon, not including the rectum.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a gastrointestinal condition.

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I have been treated with at least 2 advanced cancer drugs.

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I do not have any severe infections or take medications that are not allowed.

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I have not received a live vaccine recently and do not plan to during the study.

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I have been treated with specific biologic drugs.

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I need a procedure for my Crohn's disease complications.

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I have had major surgery to remove parts of my colon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants with Corticosteroid-free Endoscopic remission in group 1 and group 2 at week 48

Secondary study objectives

2-item Patient-Reported Outcome (PRO-2) score and corresponding changes from baseline during follow-up (Weeks 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2

Crohn's Disease Activity Index(CDAI) total score and corresponding change from baseline during follow-up (Week 6, Week 14, Week 22, Week 30, Week 38, Week 48, Week 64, Week 80, Week 96) in group 1 and group 2

Exposure-adjusted incidence rates of serious adverse events (SAEs), all adverse events (AEs), and AEs of special interest (AESIs) in group 1 and group 2

+24 more

Side effects data

From 2019 Phase 4 trial • 11 Patients • NCT02559713

Colitis ulcerative

Gastrointestinal motility disorder

Viral infection

Crohn's disease

Paronychia

100%

80%

60%

40%

20%

Study treatment Arm

Vedolizumab 300 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2: Corticosteroid-free clinical remission + biomarker remission.Experimental Treatment1 Intervention

Group 2 will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.

Group II: Group 1: Corticosteroid-free IUS-based outcomes + clinical remission + biomarker remissionExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vedolizumab

2009

Completed Phase 4

~10220

0 / 10Eligibility criteria met