Inflammatory Bowel Disease (IBD)


If you are interested in participating in a study, please contact the Study Coordinator. See name and contact information at the beginning of each study.


Crohn's Disease Treatment Studies

AMG 181

A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of AMG 181 in subjects with moderate to severe Crohn’s disease

Enrollment status: UPCOMING

Study Coordinator: Katy Patten, (734) 615-4843, higginsSCteam@umich.edu

Drug: AMG 181 protein – subcutaneous injection (under the skin)

This is a phase 2 placebo-controlled, multiple dose study to evaluate the efficacy of AMG 181 compared with placebo as measured by the proportion of subjects in remission (CDAI score < 150) at week 8. AMG 181 is a fully human monoclonal immunoglobulin IgG2 antibody that specifically recognizes the human α4β7 integrin heterodimer. AMG 181 binds α4β7 with high affinity and blocks its interaction with MAdCAM-1. This mechanism of action of AMG 181 reduces pathological bowel inflammation. Subjects will be randomized in a 2:1:2:1 ratio to receive placebo or AMG 181 21 mg, 70 mg, or 210 mg. At the end of the double-blind period (week 24), subjects will enter a 108-week open-label period during which all subjects will receive open-label 210 mg AMG 181 every 3 months.


Tofacitinib for Crohn’s disease

A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s disease>

Enrollment status: UPCOMING

Study Coordinator: Kay Sauder, (734) 647-2564, higginsSCteam@umich.edu

Drug: Tofacitinib (CP-690,550) – oral medication

This is a phase 2b study of subjects with moderately to severely active Crohn’s disease. The medicine is a JAK inhibitor made by Pfizer. JAK inhibition is a novel approach for treating a variety of autoimmune and inflammatory diseases. JAK inhibitors interrupt signaling downstream of a multiplicity of cytokines, rather than blocking one cytokine at a time, as in case of anti-TNF or interleukin-6 blockers. It is taken in pill form.

The study lasts 8 weeks and involves a screening visit, a week 0/baseline appointment, follow-up visits at week 2, week 4, and week 7 to assess response to the medicine. Finally, at week 8 we will assess the subject’s eligibility to continue in the program. Those who complete the treatment period and meet the definition of clinical response or clinical remission will be eligible to enter a placebo-controlled maintenance study of 26 weeks and then the open-label extension study, meaning there is no placebo and you are guaranteed active drug.


PEBBLE

A phase 2a study to evaluate the efficacy and safety of MEDI2070 in subjects with moderate to severe Crohn’s disease who have failed or are intolerant to anti-tumor necrosis factor–alpha therapy. Protocol D5170C00001

Enrollment Status: OPEN

Study Coordinator: Katy Patten, (734) 615-4843, higginsSCteam@umich.edu

Drug: MEDI2070 – subcutaneous injection (under the skin) and intravenous (IV) infusion

This is phase 2 study of a new anti-IL 23 biologic randomizes patients 1:1 to biologic or placebo. The IL-23 blockade is expected to work like ustekinumab (Stelara®), but may have a more direct benefit. After 12 weeks, all patients can roll over to open-label maintenance therapy with active drug. This open-label extension can provide free drug for patients for up to 2 years.


UNITI 1, UNITI 2, IMUNITI

A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of ustekinumab induction therapy in subjects with moderately to severely active Crohn's disease

Enrollment Status: OPEN for UNITI 2

Study Coordinator: Siera Goodnight, (734) 647-1092, higginsSCteam@umich.edu

Drug: Ustekinumab (Stelara®) – intravenous (IV) infusion and subcutaneous injection (under the skin)

Ustekinumab is a fully humanized monoclonal antibody that blocks activity of interleukin 12/23. It is approved in psoriasis and psoriatic arthritis (brand name Stelara). Ustekinumab showed promising efficacy in Centocor’s phase 2a study (C0379T07) in patients who had failed conventional Crohn's disease therapy (Sandborn et al, 2008) and in Centocor’s Phase 2b study (C0743T26) of ustekinumab in Crohn's disease patients who had failed or were intolerant to TNF antagonist therapy. This is the next study of this series, which will evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn's disease who have failed or are intolerant to one or more TNF antagonist therapies. Subjects in UNITI 2 are TNF naïve.

Appointments are at screening, week 0 (drug administration via IV infusion over 1 hour), week 3, week 6, and week 8. At the week 8 appointment, subjects have the option to enter the maintenance study (IMUNITI) in which they will be re-randomized and given the study drug every 4 weeks, for up to 4 years.


Ulcerative Colitis Treatment Studies

OCTAVE

A multicentre, randomized, double-blind, placebo-controlled, parallel group study of oral CP-690,550 (JAK inhibitor) as an induction therapy in subjects with moderate to severe ulcerative colitis

Enrollment Status: OPEN

Study Coordinator: Kay Sauder, (734) 647-2564, higginsSCteam@umich.edu

Drug: Tofacitinib (CP-690,550) – oral medication

This is a phase 3 study of subjects with moderately to severely active ulcerative colitis. The medicine is a JAK inhibitor made by Pfizer. JAK inhibition is a novel approach for treating a variety of autoimmune and inflammatory diseases. JAK inhibitors interrupt signaling downstream of a multiplicity of cytokines, rather than blocking one cytokine at a time, as occurs with anti-TNF or interleukin-6 blockers. It is taken in pill form.

The study lasts 9 weeks and involves a screening visit, a week 0/baseline appointment, and follow-up visits at week 2, week 4, and week 8 to assess response to the medicine. Finally, at week 9 we will assess the subject's eligibility to continue in the program. Those who complete the treatment period and meet the definition of clinical response or clinical remission will be eligible to enter a placebo-controlled maintenance study of 52 weeks (A3921096). Subjects who complete the treatment period but do not meet the definition of clinical response or remission will be eligible to enter an open-label extension study (A3921139), meaning there is no placebo and you are guaranteed active drug.


TURANDOT

A double-blind, randomized, placebo-controlled, parallel, dose-ranging study to evaluate the efficacy and safety of PF-00547659 in subjects with moderate to severe ulcerative colitis

Enrollment Status: OPEN

Study Coordinator: Kelli Porzondek, (734) 764-0507, higginsSCteam@umich.edu

Drug: anti-MadCAM-1 (PF-00547659) – subcutaneous injection (under the skin)

This is a Phase 2 study to compare the effects of the study drug, anti-MadCAM-1 (PF-00547659), and placebo to find out which is better for treating ulcerative colitis (UC). This new subcutaneous biologic blocks the ability of blood vessels in the gut to attract white blood cells. This is the complement of anti-integrin therapies like vedolizumab, with injections given every 4 weeks. Patients are randomized to one of 4 doses of active drug or placebo (4:1) for 12 weeks, followed by an open label treatment for up to 52 weeks.


Ulcerative Colitis and Crohn's Disease Observational Studies

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: UPCOMING

Study Coordinator: Siera Goodnight, (734) 647-1092, higginsSCteam@umich.edu

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).


PREDICT

A multicenter study evaluating a practical index score for subjects with Crohn’s dIsease assessing the absence of mucosal ulceration

Enrollment Status: UPCOMING

Study Coordinator: Siera Goodnight, 734) 647-1092, higginsSCteam@umich.edu

The primary purpose of this study is to evaluate whether three new measures which are composed of questions and laboratory data can predict damage to the lining of the intestines.  These measures will be compared to the endoscopy results.  New markers for inflammation will also be collected to determine whether or not the existing measures can be improved.  This study will also determine, based on the analysis of all microbes genes in your stool sample, whether there is a definite microbiota (microscopic organisms) profile connected with the activity of Crohn’s disease and evaluate whether determining this profile may improve Crohn’s disease management. Studying and analyzing all microbes’ genes is called metagenomics.

MARQUEE

Does mucosal healing matter for cinically quiescent ulcerative colitis?

Enrollment Status: UPCOMING

Study Coordinator: Siera Goodnight, (734) 647-1092, higginsSCteam@umich.edu

This study will determine how many patients with ulcerative colitis in clinical remission have signs of active disease on their routine surveillance colonoscopy with biopsies. This study will also determine if the colonoscopy and biopsy findings of routine surveillance colonoscopies can predict the risk of a disease flare over the next 1 year. Subjects will answer questionnaires prior to their scheduled surveillance colonoscopy. A video of their endoscopy procedure will be recorded and the biopsies taken from the procedure will be re-analyzed. Subjects will be contacted every 3 months during the follow year to monitor the possible occurrence of a flare.

CCFA CDI

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

Enrollment Status: OPEN

Study Coordinator: Katy Patten, (734) 615-4843, higginsSCteam@umich.edu

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.


PRIDE

Procalcitonin as a biomarker to distinguish an inflammatory bowel disease flare from Clostridium difficile infection

Enrollment Status: OPEN

Study Coordinator: Katy Patten, (734) 615-4843, higginsSCteam@umich.edu

The goal of this study is to identify a biomarker or combination of biomarkers that can help distinguish a flare of inflammatory bowel disease (IBD) from a bacterial infection with Clostridium difficile. Additionally, we hope to identify biomarkers that can help predict those patients most at risk for a severe disease course, including inpatient admission or progression to colectomy. This is a prospective observational study with single time-point sampling of both discarded stool and serum from 250 symptomatic outpatients with ulcerative colitis and suspected C. difficile infection, with a goal of obtaining 50 symptomatic patients with ulcerative colitis and C. difficile. We will also prospectively sample iscarded stool and serum from 100 symptomatic inpatients with ulcerative colitis and suspected C. difficile infection at the time of stool collection.


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, (734) 647-2564, higginsSCteam@umich.edu

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.


Lycera

Inflammatory bowel disease (IBD) Lycera serum study

Enrollment Status: OPEN

Study Coordinator: Kelli Porzondek, (734) 764-0507, higginsSCteam@umich.edu

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, (734) 764-0507, higginsSCteam@umich.edu

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.

BÜHLMANN calprotectin ELISA method comparison to predictive device for FDA clearance

Enrollment Status: OPEN

Study Coordinator: Kay Sauder,(734) 647-2564, higginsSCteam@umich.edu

An instrument was developed by BÜHLMANN to test calprotectin levels in stool specimens in Europe, however, it is not approved by the FDA for use in the United States. This instrument would aid in the diagnosis of inflammatory bowel diseases (IBD), as well as aid in the differentiation of active versus inactive inflammation of IBD, irritable bowel syndrome (IBS), and other functional bowel syndromes.