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Clinical Research

Clinical Research Projects

The IBD Study Coordinator Team

Kay Sauder, Katy Patten, Kelli Porzondek, Anna Romans, and Karina Lizzi

How to Refer Patients for Clinical Research Studies

Email: higginsSCteam@umich.edu

Call:
734-647-2564 (Kay) or
734-615-4843 (Katy) or
734-764-0507 (Kelli) or
734-615-7977 (Anna) or
734-647-1092 (Karina)

Crohn's Disease (CD) Clinical Research 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

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

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.

 

CADHUM
Enrollment Status: Not open yet
Study Coordinator: Katy Patten
Drug: Humira (adalimumab) - SC injection
Patients who respond to Humira often want to stop this drug once they get better. In this study, we are testing whether patients who are in remission on Humira can stop their medication and only be re-dosed only if their inflammatory markers begin to increase. This requires following participants very closely, with fecal calprotectin/CRP testing every 3 months. If there is a rise in the inflammatory markers, we will treat these patients with loading doses of Humira before symptoms occur to see if we can prevent flares. The goal of this study is to see if you can treat patients with Humira only when they need the medicine.  If the study shows that Humira can be used only when needed for Crohn’s disease, everyone with Crohn’s disease will benefit.
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GEMINI OL (Crohn’s and UC)

A Phase 3, Randomized, Blinded, Multicenter Study for the Induction of Clinical Response and Remission by Vedolizumab in Patients with Moderate to Severe Crohn’s Disease (GEMINI)

Enrollment Status: CLOSED
Study Coordinator: Katy Patten
Drug: Vedolizumab – IV infusion
This study will assess the safety of a new monoclonal antibody as an induction therapy for Crohn’s AND ulcerative colitis patients who have failed conventional therapy. Vedolizumab binds to the a4B7 integrin, which is expressed on discrete popula-tions of leukocytes involved in gut mucosal immunity. Vedolizumab antagonizes both the a4B7-MAdCAM-1 interaction and the associated migration of leukocytes into GI mucosa. This mechanism of action of vedolizumab reduces pathological bowel inflammation, thus providing a potential therapeutic option for patients with CD.
This is the open-label long-term phase 3 safety study extension in which study subjects will have access to study drug for up to four years. Subjects return every four weeks for a 30 min long infusion, followed by a 1 hour long observation period. Kit labs and physical exams are only drawn every other visit.
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Ulcerative Colitis (UC) Clinical Research 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
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 in case of 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, follow-up visits atweek 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.


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.

T18/PURSUIT
A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis
Enrollment Status: CLOSED
Study Coordinator: Kelli Porzondek
Drug:  Simponi - injection under the skin

This is the 4 year-long maintenance and extension study for patients who completed the 8 week-long induction study with golimumab. This medication is a novel anti-TNF therapy made by the same company that created remicade. Visits are every 4 weeks and consist of one SC injection and 30 minute observation period. Labs and physicals occur every 3 months.
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Observational Clinical Research Studies

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.
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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.
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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: 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).
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MARQUEE

Does mucosal healing matter for cinically quiescent ulcerative colitis?

Enrollment Status: OPEN

Study Coordinator: Kelli Porzondek

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.
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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

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.
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PRIDE

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

Enrollment Status: OPEN

Study Coordinator: Katy Patten

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 discarded stool and serum from 100 symptomatic inpatients with ulcerative colitis and suspected C. difficile infection at the time of stool collection.
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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.

To Find out More, Contact the University of Michigan IBD Study Coordinators:

higginsSCteam@umich.edu

or

Kay Sauder 734-647-2564

Katy Patten 734-615-4843

Karina Lizzi 734-647-1092

Kelli Porzondek 734-764-0507
Kelli

Anna Romans 734-615-7977