Clinical Research Projects

The IBD Study Coordinator Team

Carrie Bergmans, Kelli Porzondek, Katy Patten, Kay Sauder, and Andy Biehl

 

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.

Novel biomarkers of intestinal fibrosis in Crohn's disease

Principal Investigator: Peter Higgins, MD, PhD, MSc

Enrollment Status: OPEN

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

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.

FINCH - Observational multicenter study in patients with Crohn's disease for characterization of magnetic resonance enterography (MRE) assays for assessment of disease activity

Principal Investigator: Peter Higgins, MD, PhD, MSc

This study looks to assess MRE as an alternative imaging method for the assessment of inflammatory status in patients with Crohn's disease. If it is determined that a patient is eligible to participate in this study, they will visit the University of Michigan multiple times over the course of 4 weeks. They will undergo one ileocolonoscopy within the first 2 weeks and two MREs over the course of the second 2 weeks. Additionally, our study team will monitor their physical condition by performing various tests, such as vital sign measurements, physical examinations, and blood draws.

 

UNITI 1 or UNITI 2 - 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

Principal Investigator: Peter Higgins, MD, PhD, MSc

Enrollment Status: OPEN

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.

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 stud (IMUNITI) in which they will be re-randomized and given the study drug every 4 weeks, for up to 4 years.

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A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of GSK 1605786A in the treatment of subjects with moderately to severely active Crohn's disease

Principal Investigato: Peter Higgins, MD, PhD, MSc

Enrollment Status: OPEN

Drug: GSK 1605786A - oral medication

This study will assess the effectiveness of a new compound, GSK1605786A, compared to placebo as an induction therapy for Crohn's patients over 12 weeks. This is an orally administered chemokine antagonist that specifically blocks the migration of gut-specific T cells, which selectively home to the intestine.

Subjects will return every 2 weeks over the 12-week treatment period. Every other visit is simply a blood draw to monitor drug response. 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 (CCX115157). 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 (CCX114644), where they will be given the study drug for 2 years.

 

 

Ulcerative Colitis (UC) Clinical Research Studies

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

Principal Investigator: Peter Higgins, MD, PhD, MSc

Enrollment Status: OPEN

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.

Upcoming Studies:

Title: Novel Biomarkers of Intestinal Inflammation and Fibrosis in Crohn's Disease (HUM 32452)
PI: Peter Higgins, MD, PhD, MSc

Description: 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 CD. The specific aims of this study are three-fold: To determine if levels of novel markers of IF discovered by proteomic analysis correlate with the presence and burden of fibrostenotic disease in patients with CD, 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 IF 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 CD who have active disease, intestinal narrowing, and are scheduled for surgical resection will be recruited for this study.

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.