Skip Navigation

Inflammatory Bowel Disease (IBD)

printer friendly version


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!


Crohn's Disease Treatment Studies


Ulcerative Colitis Treatment Studies


Ulcerative Colitis and Crohn's Disease Observational Studies



Crohn's Disease Treatment Studies


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.


Ulcerative Colitis Treatment Studies


Hibiscus


A phase 3, randomized, double-blind, double-dummy, placebo-controlled, multicenter study to evaluate the efficacy (induction of remission) and safety of Etrolizumab compared with adalimumab and placebo in patients with moderate to severe ulcerative colitis who are naïve to TNF inhibitors.

Enrollment Status:OPEN

Study Coordinator: Kay Sauder

Drug: Etrolizumab, anti-integrin β7 – subcutaneous injection (under the skin); adalimumab (Humira®) – subcutaneous injection

This is a phase 3 study for patients with moderate to severely active ulcerative colitis who have failed or who are intolerant of immunosuppressant treatment (azathioprine, methotrexate, 6-MP) but have not tried anti-TNF medications (Remicade®, Humira®, Simponi®). There are 2 possible study medicines that patients will be assigned to: Etrolizumab and adalimumab. Etrolizumab contains a new class of molecules that target the β7 integrin receptor in the lining of the gut to regulate white blood cell trafficking. Adalimumab is an anti-TNF medicine currently approved for the treatment of ulcerative colitis, Crohn’s disease, and other autoimmune diseases.

The study lasts up to 14 weeks and involves a screening visit, baseline enrollment visit, and follow-up drug administration visits every 2–4 weeks. Patients are also required to have a colonoscopy done at screening and week 10 to assess disease activity and response to the study medicine. Patients who enroll in the study will be randomly assigned to Etrolizumab, adalimumab, or placebo (inactive medicine). All patients have a 20% chance of receiving placebo. After completing the Hibiscus study, patients have the option to roll over to the open-label portion of the study, known as Cottonwood, and receive active study medicine for up to 7 years or until the study medicine is approved by the FDA.


Hickory


A phase 3, double blind, placebo-controlled multicenter study of the efficacy and safety of etrolizumab during induction and maintenance in ulcerative colitis who are refractory to or intolerant of TNF inhibitors

Enrollment Status: OPEN

Study Coordinator: Kay Sauder

Drug: Etrolizumab, anti-integrin β7 – subcutaneous injection (under the skin)

This is a phase 3 study for patients with moderate to severely active ulcerative colitis who have failed or been intolerant to Remicade® and/or adalimumab. The study medication, etrolizumab, contains a new class of molecules that target the β7 integrin receptor in the lining of the gut to regulate white blood cell trafficking.

The study lasts up to 66 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 66 in order 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 Hickory study, patients have the option to roll over into the open-label portion of the study known as Cottonwood, and receive active study medication for up to 7 years or until the medication is approved by the FDA.


M14 – SERENE UC


A double-blind, randomized, multicenter study of higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active ulcerative colitis

Enrollment status: OPEN

Study Coordinator: Karina Lizzi

Drug: HUMIRA®

This is a phase 3 study for subjects with moderately to severely active ulcerative colitis to evaluate a high-dose HUMIRA® induction regimen versus a standard-dose induction regimen, followed by high-dose versus standard-dose maintenance therapy. Patients will be randomized in a 1:1 ratio to receive a standard- versus high-induction dose over an 8-week period. At week 8, patients are re-randomized to receive maintenance dosing at 40 mg every week or 40 mg every 2 weeks. The treatment period will last up to 44 weeks.


Ulcerative Colitis and Crohn's Disease Observational Studies


CCFA CDI


Clostridium difficile infection (CDI) induces changes in the gut microbiome that lead to ulcerative colitis flares

Enrollment Status: OPEN

Study Coordinator: Jen Dixon

The long-term goal of this project is to identify what causes flares of ulcerative colitis (UC). Patients with UC can stay in remission for months or years, but the threat of a flare of disease is always present. We have little understanding of what actually triggers flares of UC, and few opportunities to study flares before they start. Several recent studies have elucidated the role of Clostridium difficile infection (CDI) in triggering flares in patients with UC, leading to extended hospital stays, more severe disease, and a high rate of colectomy. This is a prospective cohort study with longitudinal sampling of stool microbiome from UC patients with CDI, non-IBD patients with CDI, and UC patients with non-CDI flares.

We will use deep microbial 454 sequencing to determine whether specific changes in the gut microbiome in UC patients infected with Clostridium difficile are predictive of two adverse clinical outcomes in UC patients: UC flares induced by C. difficile infection, and recurrence of C. difficile infection.


GEM Project


A multidisciplinary human study on the genetic, environmental and microbial interactions that cause inflammatory bowel disease

Enrollment Status: OPEN

Study Coordinator: Kay Sauder

This study is for healthy first degree relatives of patients with Crohn’s and it is funded by the Crohn’s and Colitis Foundation of Canada (CCFC). Healthy volunteer participation includes one visit with a blood, stool, and urine sample, and a few surveys. A research team member will call the volunteer once every 6 months for the next 5 years to see if any new IBD symptoms have occurred.


Legacy


A long-term non-interventional registry to assess safety and effectiveness of HUMIRA® (adalimumab) in patients with moderately to severely active ulcerative colitis (UC)

Enrollment Status: OPEN

Study Coordinator: Anna Romans

The purpose of this research study is to collect long-term safety information on HUMIRA® (adalimumab), a monoclonal antibody approved for the treatment of moderate to severely active ulcerative colitis (UC). Information will also be collected if subjects are using one of the two immunomodulator medications, azathioprine (AZA), and 6-mercaptopurine (6-MP).


Lycera


Inflammatory bowel disease (IBD) Lycera serum study

Enrollment Status: OPEN

Study Coordinator: Kelli Porzondek

This is an exploratory study to test a novel biologic compound targeting circulating active T-cells on a blood sample from subjects with inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC). This study is based on preliminary data obtained by researchers in Italy showing that some activated T cells can be specifically killed by new drugs. We will explore the mechanism of action and basis for selectivity in this subset of cells for biomarker development. This study involves only a single blood draw.


Novel biomarkers of intestinal fibrosis in Crohn's disease

Enrollment Status: OPEN

Study Coordinator: Kelli Porzondek

The hypothesis of this study is to determine if blood-based biomarkers of intestine-specific fibrogenesis and fibrosis will identify and quantify fibrostenotic intestinal damage, providing prognostic value for complications of Crohn's disease. The specific aims of this study are three-fold: to determine if levels of novel markers of intestinal inflammation discovered by proteomic analysis correlate with the presence and burden of fibrostenotic disease in patients with Crohn's disease; to determine if identified biomarkers of fibrosis predict the long-term development of fibrosis and recurrent intestinal fibrostenotic disease in post-operative patients; and finally, to determine if identified biomarkers of intestinal inflammation provide unique prognostic and predictive disease monitoring information compared to other biomarkers of disease activity including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and lactoferrin. Patients with Crohn's disease who have active disease, intestinal narrowing, and who are scheduled for surgical resection will be recruited for this study.