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Clinical Research

Clinical Research Projects

The IBD Study Coordinator Team

Kelli Porzondek, Katy Patten, Siera Goodnight, and Kay Sauder

 

How to Refer Patients for Clinical Research Studies

Email: higginsSCteam@umich.edu

Call: 734-615-4843 or 734-615-2457

 

Crohn's Disease (CD) Clinical Research Studies

Title: Ultrasound Elasticity Imaging (UEI) to Measure Fibrosis in Crohn's disease (HUM 12895)
PI: Peter Higgins, MD, PhD, MSc

Description: This pilot study, for which we have applied for NIH funding, is investigating whether ultrasound through the skin of the abdomen can measure how stiff the intestine is in a narrowed area. We have preliminary data from rats that shows that UEI can measure intestinal stiffness, and that this measures the progressive scarring of the intestine. We are testing this ultrasound approach on patients who are going to surgery for intestinal narrowing due to CD, and comparing the ultrasound results to the findings of scarring in the removed intestine. If this is successful, we will have a way to measure whether people are developing intestinal scarring before they have a blockage, and perhaps institute therapy to slow the progress or reverse the scarring, before an intestinal obstruction occurs.

BUHLMANN calprotectin ELISA method comparison to predictive device for FDA clearance

Principal Investigator: Peter Higgins, MD, PhD, MSc

An instrument was developed by BUHLMANN 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.

 

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
Drug: Ustekinumab (Stelara) - intravenous (IV) infusion and subcutaneous (SC) injection
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 naive.
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.


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
Drug: MEDI2070 - SC injection and IV
This 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.

 

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.

 

TRUST
A Phase II study to evaluate the efficacy and safety of 12 weeks of treatment with oral CND 201 Trichuris Suis Ova suspension (TSO) as compared to placebo, followed by a 12 week open-label treatment period in patients with moderately to severely active Crohn’s disease
Enrollment Status: CLOSED
Study Coordinator: Siera Goodnight
Drug: Trichuris suis ova (TSO) - oral medicine
This study is evaluating an investigational biological study product that is a new approach to treating Crohn's disease based on the ideas above. This study will examine the safety, effectiveness, and tolerability of Trichuris suis ova (TSO), a type of probiotic, compared to placebo in people who have Crohn's disease. TSO are the eggs of a very small worm called a "helminth." TSO were chosen because they are not a human parasite, and can't live for more than a few weeks in your body. After being swallowed, TSO’s temporary presence in the gut causes a reaction from your immune system. The researchers doing this study think that the TSO may "distract" your body so that it fights the worm and possibly won't "attack" the person's body anymore. Early clinical trials show that TSO may be effective in treating active Crohn's disease.
Appointments are at screening, screening colonoscopy, week 0, week 2, and every 2 weeks from there on, for 24 weeks. If you complete all visits, you will receive up to $1,385.00 compensation for your time and travel.

 

PREVENT
Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence
Enrollment Status: CLOSED
Study Coordinator: Kelli Porzondek
Drug: Infliximab (Remicade)

This study will test whether Remicade (already approved in Crohn’s disease and Ulcerative Colitis), given after surgery for Crohn’s disease can prevent disease symptoms from coming back. Eligible patients may receive medication for up to 4 years. Subjects come to the site every 8 weeks for two hour infusion of study drug with one hour long observation period. At week 76, subjects will have video ileocolonoscopy, then they will resume every 8 week schedule.

 

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: Siera Goodnight
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.


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.


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
Drug: anti-MadCAM-1 (PF-00547659) - SC injection

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.

 

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.

 

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.


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.

 

BUHLMANN calprotectin ELISA method comparison to predictive device for FDA clearance
Enrollment Status: OPEN
Study Coordinator: Kay Sauder
An instrument was developed by BUHLMANN 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.

 


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

 

Siera Goodnight 734-647-1092
Siera

 

Kelli Porzondek 734-764-0507
Kelli