Crohn's Disease Treatment Studies

If you are looking for clinical trials for Crohn's disease you have come to the right place! As researchers, our goal is to discover new therapies and information about Inflammatory Bowel Disease (IBD), but most importantly, provide an alternate therapy that helps YOU. We welcome you to the IBD Research Team and encourage you to look at the studies below that you may qualify for. We will update this site periodically, so keep checking this page for new studies. If you have ANY questions or are interested in participating please feel free to call (734) 615-4843 or e-mail higginsSCteam@umich.edu. We hope to hear from you soon!


Bergamot

A phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of etrolizumab as an induction and maintenance treatment for patients with moderately to severely active Crohn's disease

Enrollment status: OPEN

Study Coordinator: Jen Dixon

Drug: Etrolizumab, injection under the skin

This is a phase 3 study for patients with moderate to severely active Crohn's disease to evaluate the safety and effectiveness of etrolizumab, a beta7 anti-integrin that acts on the lining of the gut to block white blood cell trafficking. The study lasts up to 72 weeks and involves a screening visit, baseline enrollment visit, and follow-up drug administration visits every 4 weeks. Patients are also required to have a colonoscopy done at screening, week 14, and week 72 to assess disease activity and response to study medication. Patients who enroll in the study will be randomly assigned to etrolizumab or placebo (inactive medication). All patients have a 20% chance of receiving placebo. After completing the Bergamot study, patients have the option to roll over into the open-label portion of the study known as Juniper, and receive active study medication for up to 6 years or until the medication is approved by the FDA.


Gilead – CD

A phase 2, double-blind, randomized, placebo-controlled, multicenter study evaluating the safety and efficacy of GS-5745 in subjects with moderately to severely active Crohn’s disease

Enrollment status: OPENING SOON

Study Coordinator: Kelli Porzondek

Drug: GS-5745, injection under the skin

This is a phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of an 8-week induction regimen of GS-5745 administered subcutaneously in treating subjects with moderately to severely active Crohn's disease. This study is designed to evaluate the efficacy and safety of GS-5745 for the induction of clinical response and remission. Open Label Extension – 150 mg of GS-5745 for an additional 44 weekly doses for eligible subjects who complete the week 8 assessment.


M14 – SERENE CD

A multicenter, randomized, double-blind study to evaluate the efficacy and safety of two adalimumab induction regimens in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration

Enrollment status: OPEN

Study Coordinator: Karina Lizzi

Drug: HUMIRA®

This is a phase 3 study for subjects with moderately to severely active Crohn’s disease to evaluate the efficacy and safety of two HUMIRA® induction regimens followed by standard maintenance therapy with HUMIRA®. Patients are randomized in a 1:1 ratio to receive either the standard induction dose or the higher induction dose of HUMIRA® followed by HUMIRA® every other week for 12 weeks. All patients will then roll over into a maintenance phase and continue to receive HUMIRA® every other week for up to 40 weeks.


Rifaximin (RECD3125)

A double-blind, placebo-controlled, parallel-group, multicenter, multiregional, one year study to assess the efficacy and safety of twice daily oral rifaximin delayed release tablets for induction of clinical remission with endoscopic response at 16 weeks followed by clinical and endoscopic remission at 52 weeks in subjects with active moderate Crohn's disease

Enrollment status: OPEN

Study Coordinator: Jen Dixon

Drug: Rifaximin

This is a one year study to assess the efficacy and safety of twice daily oral rifaximin delayed-release (DR) tablets in subjects with active moderate Crohn's disease. Patients will be randomized in a 1:1 ratio at week 0 to either rifaximin DR tablets 800 mg twice daily or placebo. The treatment period will last up to 52 weeks and will assess clinical remission and endoscopic response.


RODIN – CD

A randomized, controlled trial of high-dose vitamin D in Crohn’s disease

Enrollment status: OPEN

Study Coordinator: Jen Dixon

Drug: Vitamin D3

The purpose of this study is to determine if high-dose versus low-dose vitamin D supplementation among patients with Crohn’s disease and vitamin D deficiency improves clinical outcomes. Patients will be randomly assigned to either a low dose (400 international units) or a high dose (10,000 international units) vitamin D supplement and will be asked to come to U of M for a total of 5 visits over the course of a year to complete necessary study procedures (blood draws, stool collection, questionnaire completion, etc.).


Versify – CD

An open-label phase 3b study to assess mucosal healing in subjects with moderately to severely active Crohn’s disease treated with vedolizumab IV

Enrollment status: OPEN

Study Coordinator: Kelli Porzondek

Drug: Vedolizumab, IV infusion

This is a phase 3b, single-arm, open-label multicenter study to evaluate the efficacy and safety of vedolizumab 300 mg IV infusion over a 26-week treatment period using ileocolonoscopy for the assessment in subjects with Crohn’s disease.The study consists of a 4-week screening period, a 26-week treatment period (with the last dose at week 22), and an 18-week follow-up period following the last dose. The duration of the study will be approximately 44 weeks for all subjects. All subjects included in the study will also have a 6-month safety follow-up telephone call following the last dose. The end of trial will be the date of the last visit of the last subject for the week 40 follow-up visit.