← Back to Search

Monoclonal Antibodies

Vedolizumab + Adalimumab/Ustekinumab for Crohn's Disease

Phase 4

Recruiting

Research Sponsored by Takeda

Eligibility Criteria Checklist

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

Must have

Has moderately to severely active CD at Screening, defined as a CDAI score ≥220 and a SES-CD ≥6 (≥4 if isolated ileal disease).

- Intolerance (a significant adverse event that precluded further use, including but not limited to serious infection including opportunistic infections, malignancy, infusion-related and hypersensitivity reactions including anaphylaxis, and liver injury).

Must not have

A current diagnosis of ulcerative colitis or indeterminate colitis.

Known perianal fistula with abscess.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 12, 26 and 52

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test the effect of dual and single targeted treatments on Crohn's Disease. Participants will receive dual treatment first, with follow-up of at least 26 weeks.

Who is the study for?

Adults with moderate to severe Crohn's Disease who have had an inadequate response, lost response, or intolerance to certain treatments. They must have a confirmed diagnosis for at least 3 months and meet specific disease severity scores. Not eligible if they've had extensive colon resections, certain infections like TB or HIV, previous nonresponse to multiple treatments, or any immunodeficiency.

What is being tested?

The trial is testing the effectiveness of vedolizumab IV in combination with either adalimumab or ustekinumab in treating Crohn's Disease. Participants first receive dual therapy (Part A), then those responding continue with only vedolizumab (Part B). The follow-up period lasts at least 26 weeks post-treatment.

What are the potential side effects?

Potential side effects include allergic reactions such as anaphylaxis, serious infections including opportunistic ones, malignancy risks due to immune system suppression, liver injury from drug intolerance and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

My Crohn's disease is active, with a high severity score.

Select...

I have experienced severe side effects from a treatment that I cannot tolerate.

Select...

My condition did not improve after finishing the initial treatment plan.

Exclusion Criteria

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

Select...

I have been diagnosed with ulcerative colitis or indeterminate colitis.

Select...

I have a perianal fistula with an abscess.

Select...

I have short bowel syndrome.

Select...

I am not planning any surgery for Crohn's disease except for a seton placement.

Select...

I have untreated polyps in my colon.

Select...

I cannot undergo an ileocolonoscopy due to intolerance or medical reasons.

Select...

I have a condition that weakens my immune system, like HIV.

Select...

I have tuberculosis, whether it's active or not.

Select...

I have received specific antibody treatments for my condition.

Select...

I have or had an abdominal abscess.

Select...

I have Crohn's disease and did not respond to at least 2 treatments with IL or TNF blockers.

Select...

I have tested positive for hepatitis B.

Select...

I have an ileostomy, colostomy, or severe intestinal blockage.

Select...

I do not have any abnormal connections between organs except for a perianal fistula.

Select...

I have had abnormal growths in my colon.

Select...

I have tested positive for hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 12, 26 and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 12, 26 and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12, 26 and 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part A: Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 26

Part B: Percentage of Participants in Clinical Remission Based on the CDAI at Week 52

Secondary study objectives

Change in PRO2 Score from Week 26 to 52

Change in SES-CD from Baseline to Weeks 26 and 52

Percentage of Participants Achieving 2-item Patient-reported Outcome Measure (PRO2) Remission at Weeks 12, 26, and 52

+12 more

Awards & Highlights

Drug Has Already Been Approved

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

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.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part B: Vedolizumab MonotherapyExperimental Treatment1 Intervention

Participants who achieve clinical remission in Part A will receive vedolizumab IV 300 mg monotherapy, Q8W from Week 30 until Week 46.

Group II: Part A, Cohort 2: Vedolizumab + UstekinumabExperimental Treatment2 Interventions

Participants will receive vedolizumab IV 300 mg, at Weeks 0, 2, and 6, then Q8W until Week 22 and ustekinumab IV 520, 390, or 260 mg (weight-based), then SC 90 mg 8 weeks after initial IV dose, then Q8W until Week 24.

Group III: Part A, Cohort 1: Vedolizumab + AdalimumabExperimental Treatment2 Interventions

Participants will receive vedolizumab IV 300 mg, at Weeks 0, 2, and 6, then every 8 weeks (Q8W) until Week 22 and adalimumab SC 160, 80, and 40 mg at Weeks 0, 2, and 4, respectively, then 40 mg every 2 weeks (Q2W) until Week 26.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ustekinumab

2015

Completed Phase 4

~4080

Adalimumab

2013

Completed Phase 4

~7950