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: Kay Sauder
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.
LUX
Enrollment status: OPEN
Study Coordinator: Kimberly Brunette
Drug: MEDI2070, infusion and injection under the skin
This is a phase 2 study for patients with moderate to severely active Crohn’s disease to evaluate the safety and effectiveness of a new biologic medication targeting interleukin-23. The duration of the study could be up to 56 weeks, including a screening period (4 weeks), a 16-week double-blind induction period, a 12-week maintenance phase, and a 24-week open label period.
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: Jennifer Dixon
Drug: adalimumab (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.
Ulcerative Colitis Treatment Studies
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.
LILLY
Enrollment status: OPEN
Study Coordinator: Jennifer Dixon
Drug: LY3074828 (anti-IL23)
A phase 2, multicenter, randomized, double-blind, parallel, placebo-controlled study of LY3074828 in subjects with moderate to severe ulcerative colitis. If enrolled in the study, patients have the ability to receive free drug for up to 92 weeks.
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: Jennifer Dixon
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.
Ozanimod
A phase 3, multicenter, randomized, double-blind, placebo-controlled trial of oral RPC1063 as induction and maintenance therapy for moderate to severe ulcerative colitis
Enrollment status: OPEN
Study Coordinator: Angela Theil
Drug: Ozanimod (RPC1063), oral tablet
This is a multicenter, randomized, double-blind, placebo-controlled trial of RPC1063 as induction and maintenance therapy for moderate to severe UC. The trial will be conducted at approximately 250 sites in North America, Europe, Asia Pacific, South America, and South Africa.
The trial is composed of two periods: an Induction Period and a Maintenance Period. Patients will be entered into the trial in two separate cohorts through the Induction Period and those patients in clinical response at the end of the Induction Period will proceed through to the Maintenance Period. Patients who participate in this trial may also qualify to participate in an optional Open Label Extension.
UNIFI
Enrollment status: OPEN
Study Coordinator: Angela Theil
Drug: ustekinumab (Stelara®), injection under the skin
This is a phase 3 study for patients with moderate to severe active ulcerative colitis to evaluate the safety and effectiveness of ustekinumab (anti-interleukin 12/23). The total time in the study could be up to approximately 220 weeks (4.25 years).
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: Kimberly Brunette
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.
Cimzia® Secure
A non-interventional long-term post-marketing registry of patients treated with certolizumab pegol (Cimzia®) for Crohn's disease
Enrollment Status: OPEN
Study Coordinator: Anna Romans
This is a long-term observational safety study that will include about 4000 patients with Crohn's disease. The objective of this registry is to measure and compare the safety outcomes among patients who are taking Cimzia® and those who have a different Crohn's disease treatment regimen.
GEM Project
A multidisciplinary human study on the genetic, environmental and microbial interactions that cause inflammatory bowel disease
Enrollment Status: OPEN
Study Coordinator: Kimberly Brunette
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.
