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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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 12, 26, 42, and 52

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 12, 26, 42, and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, weeks 12, 26, 42, and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 12, 26, 42, and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in FCP Concentrations from Baseline to Weeks 12, 26, 42, and 52

Change in PRO2 Score from Week 26 to 52

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

+13 more

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

Vedolizumab

2009

Completed Phase 4

~10330

Adalimumab

2013

Completed Phase 4

~6480

Ustekinumab

2013

Completed Phase 4

~4140

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,203 Previous Clinical Trials

4,177,794 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,211 Previous Clinical Trials

489,122 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility threshold for this trial confined to those aged 55 and below?

"In accordance with the requirements of this trial, potential patients must be above 18 years old and below 65."

Answered by AI

What is the risk associated with Part A, Cohort 1: Vedolizumab + Adalimumab?

"Considering that it is a Phase 4 trial, which suggests the treatment in question has been approved, our Power team assigned Part A, Cohort 1: Vedolizumab + Adalimumab a safety rating of 3."

Answered by AI

Are any new enrolments being made into this research project at present?

"Current data on clinicaltrials.gov has shown that this medical trial, posted in January 2024 and most recently updated in September 2023, is not presently recruiting patients. However, there are 265 other trials actively searching for participants at the moment."

Answered by AI

What are the criteria for individuals to qualify to participate in this experiment?

"This medical trial seeks 150 individuals aged 18 to 65 who suffer from Crohn's disease. In addition, these patients must have experienced an inadequate response after completing the full induction regimen; lost their previous clinical benefit during scheduled maintenance dosing; or had a significant adverse event which precluded further use (e.g., serious infection including opportunistic infections, malignancy, infusion-related and hypersensitivity reactions including anaphylaxis, and liver injury)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease

2024. "A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06045754.