Featured Research
The Crohn's & Colitis Foundation collaborates with academic and industry researchers to help enroll patients with Crohn’s disease and ulcerative colitis into clinical studies. The list below highlights our partners' current research studies. Please note that these partners have paid to have their trials posted below, and the Crohn's & Colitis Foundation does not endorse any particular study.
For a comprehensive listing of all research studies currently recruiting patients, please visit our IBD Clinical Trial Finder.
Search the listing by typing in your city, state, zip code or disease into the search box. You can also search using multiple keywords, such as state and disease type.
Phase 1
Sponsor: AbbVie
Description: To compare different methods of stool collection and preservation from healthy and inflammatory bowel disease (IBD) volunteers to determine which methods are optimal for preserving samples for multiple analytic methods. In addition, stool, urine, and blood samples from all study volunteers will be banked for further investigation.
Phase 1
Sponsor: Aevi Genomic
Description: The primary objective of the TRaCk LIGHT study is to assess the safety and tolerability of MDGN-002 administered by injection to adults with moderate to severe, active Crohn’s disease (CD) who have failed prior treatment with an anti-tumor necrosis factor alpha (TNFα) agent.
Phase 2
Sponsor: Allergan
Description: The primary objective of this study is to evaluate the efficacy and safety of a study drug versus placebo in patients with moderately to severely active Ulcerative Colitis.
Phase 2
Sponsor: Arena Pharmaceuticals
Description: The purpose of the OASIS clinical study is to learn whether an investigational medication is safe and if it will effectively reduce the inflammation of the gut in patients with ulcerative colitis (UC).
Phase 2
Sponsor: Arena Pharmaceuticals
Description: This study is being conducted to assess the tolerability and safety of an investigational new drug in patients with Crohn's Disease who have abdominal pain.
Survey
Sponsor: Baylor
Description: Baylor College of Medicine is conducting telephone interviews with volunteers living with Crohn's disease or ulcerative colitis. Patients will be asked to share their views and experiences with colonoscopy and perceptions of colon cancer. The goal of this research is to better understand how patients with Crohn's and colitis make decisions about colonoscopy and the barriers they face in undergoing colonoscopy.
Phase 3
Sponsor: Boehringer Ingelheim
Description: Primary Objective: The primary objective of this trial is to compare the clinical efficacy of BI 695501 with Humira® in patients with active Crohn's disease (CD). Secondary Objectives: The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with Humira® across the induction and maintenance phases.
Phase 3
Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc.
Description: To prove the concept of clinical activity of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II): To confirm efficacy and safety of BI 655130 in patients with moderate-to severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III).
Other
Sponsor: Boston Children's Hospital
Description: This study investigates the safety and clinical effect of a medicine called “Interleukin-2”, or “IL-2” in people with active ulcerative colitis.
Phase 2
Sponsor: Eli Lilly
Description: The primary objective of this study is to test the hypothesis that treatment with LY3074828 is superior to placebo in inducing clinical remission at Week 12 in subjects with moderate to severe ulcerative colitis (UC). The secondary objectives are: -To evaluate the safety and tolerability of treatment with LY3074828. -To evaluate the efficacy of treatment with LY3074828 in inducing a clinical response at Week 12. -To evaluate endoscopic remission at Week 12 and Week 52. -To evaluate the effect of maintenance treatment with LY3074828 on the durability of clinical remission, endoscopic remission, and clinical response at Week 52. -To evaluate the effect of LY3074828 on health outcomes/quality of life measures. -To characterize the pharmacokinetic (PK) profile of LY3074828.
Phase 3
Sponsor: Genentech
Description: The primary objective is to evaluate the efficacy and safety of etrolizumab (105 mg SC every 4 weeks) compared with placebo for the induction of remission in TNF-naive patients with Ulcerative Colitis as determined by the Mayo Clinic Score at Week 10. A key secondary objective is evaluating the efficacy of etrolizumab compared with adalimumab for the induction of remission at Week 10.
Phase 3
Sponsor: Genentech
Description: 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. The primary objectives are to evaluate the efficacy and safety of etrolizumab (210mg or 105mg subcutaneous injections) compared with placebo at the end of the Induction Phase and to evaluate the efficacy and safety of etrolizumab (105mg subcutaneous injections) compared with placebo at the end of the Maintenance Phase.
Open Label Extension
Sponsor: Genentech
Description: The objectives of this open-label extension−safety monitoring (OLE-SM) study are as follows: Part 1 (Open-Label Extension; OLE) • To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE) Part 2 (Safety Monitoring; SM) • Progressive multifocal leukoencephalopathy (PML)
Phase 3
Sponsor: Genentech
Description: The primary efficacy objectives for this study are as follows: • To evaluate the efficacy of etrolizumab (105 mg SC every 4 weeks [Q4W]) compared with placebo for the induction of remission in patients with UC as determined by the MCS at Week 14 • To evaluate the efficacy of etrolizumab (105 mg SC Q4W) compared with placebo for maintenance of remission at Week 66 for randomized patients in remission at Week 14
Phase 3
Sponsor: Genentech
Description: The primary objective is to evaluate the efficacy and safety of etrolizumab (105 mg SC every 4 weeks) compared with placebo for the induction of remission in TNF-naive patients with Ulcerative Colitis as determined by the Mayo Clinic Score (MCS) at Week 10. A key secondary objective is evaluating the efficacy of etrolizumab compared with adalimumab for the induction of remission at Week 10.
Phase 3
Sponsor: Genentech
Description: The primary objective is to evaluate the efficacy of etrolizumab (105 mg SC every 4 weeks [Q4W]) compared with placebo for maintenance of remission at Week 62 for randomized patients in remission at Week 10 in patients who have not previously been treated with TNF inhibitors.
Open Label Extension
Sponsor: Genentech
Description: The primary objectives are to assess the long-term safety and efficacy of etrolizumab (105 mg subcutaneous injection every 4 weeks) and Progressive Multifocal Leukoencephalopathy (PML). safety monitoring in patients that were previously enrolled in etrolizumab Phase II study (protocol OLE - GA27927) and in any of the Phase III etrolizumab studies (protocols GA28948, GA28949, GA28950, GA29102, or GA29103).
Open Label Extension
Sponsor: Gilead
Description: The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).
Open Label Extension
Sponsor: Gilead
Description: The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).
Phase 3
Sponsor: Gilead
Description: The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in Patients who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896).
Phase 2
Sponsor: Gilead
Description: The aim of this study is to test if an experimental medicine that blocks mediators of inflammation (filgotinib) will help treat perianal fistula in a greater number of participants than those treated with a placebo tablet when given to people with Crohn's disease who have actively draining perianal fistulae.
Phase 2
Sponsor: Gilead
Description: The aim of this study is to test if an experimental medicine that blocks mediators of inflammation (filgotinib) will help achieve clinical remission in a greater number of participants than those treated with a placebo tablet when given to people with Crohn's disease who have active inflammation in at least part of their small bowel.
Other
Sponsor: Gilead
Description: The primary objectives of this study are to evaluate the safety and efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in patients who are biologic-naive and biologic-experienced. Patients who complete the study or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899).
Phase 2
Sponsor: Gilead Sciences, Inc.
Description: To find out how filgotinib affects testicles by seeing whether the concentration of sperm decreases by half or more in male patients after they have taken the study drug for 13 and 26 weeks.
Phase 1
Sponsor: Harvard Medical/Brigham
Description: One key provision of the FDA Amendments Act of 2007 granted the FDA the power to mandate that manufacturers implement so-called risk evaluation and mitigation strategies (REMS) for drugs with certain serious side effects to make it more likely that these treatments would be used in ways that maximized their benefits and minimized their risks. A REMS can simply entail a specially-designed medication guide to highlight appropriate use to prescribers, or can involve more complex elements to assure safe use (ETASU) typically reserved for drugs with the most serious safety concerns. Such ETASU can range from patient monitoring through enrollment in a registry; person, place, and volume restrictions on dispensation; and physician and pharmacist training and certification. Little is known about the effects of such programs on physicians, patients, and manufacturers, including whether such additional prescribing burdens reduce patient access, enhance costs, or improve patients’ experiences with their illnesses. We are seeking to better understand the burdens and benefits of ETASU REMS on patient care.
Survey
Sponsor: Icahn School of Medicine at Mt. Sinai Hospital
Description: Microbes that live inside the human body provide a wide range of functions that the human body lacks. However, they are also linked to diseases, such as Crohn's disease and ulcerative colitis (collectively called inflammatory bowel disease, or IBD). Recently, it has been shown that newborns carry bacteria transferred from their mothers. We would like to determine how and when maternal bacteria are transferred to a baby from mothers with and without IBD. This information can help us develop novel strategies to limit risk transmission from a mother to a baby.
Other
Sponsor: Investigator Initiated
Description: To investigate the underlying mechanisms of sex differences in statural growth impairment and to develop a predictive model to identify patients at highest risk for developing growth impairment refractory to standard therapeutic approaches
Phase 1
Sponsor: Mayo Clinic
Description: The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with fistulizing Crohn’s disease. Autologous means these cells to coat the plug come from the subject and is used only on that same subject. The purpose is also to find out about side effects of the MSC coated fistula plug, and if the plug is safe for people. Everyone in this study will receive the MSC coated fistula plug, which is still experimental and isn’t approved by the U.S. Food and Drug Administration (FDA).
Survey
Sponsor: Mount Sinai Hospital
Description: Recruit unaffected siblings and offspring of Crohn’s disease patients and prospectively measure environmental exposures, genetic makeup, changes in enteric microbial flora, and changes in immune responses in relation to the barrier function of the intestine. These will be studied in an attempt to identify the changes that determine who develops Crohn’s disease.
Other
Sponsor: New York University (NYU) School of Medicine
Description: To evaluate for protective gut microbiomes that prevent or delay IBD-onset in genetically predisposed individuals.
Phase 2
Sponsor: Pfizer
Description: The primary objectives of this study are to determine if an investigational drug, called PF-06480605, is safe, tolerable, and effective in the treatment of patients with moderate to severe ulcerative colitis.
Phase 2
Sponsor: Pfizer
Description: The purpose of this research study is to compare the effects of the study drugs, PF-06651600 and PF-06700841, with placebo to find out which is better for treating UC. PF-06651600 and PF-06700841 are investigational drugs.
Phase 2
Sponsor: Pfizer
Description: To evaluate the effectiveness of study drug PF 06651600 and study drug PF 06700841 compared to placebo (harmless pill) at Week 12 in participants with moderate to severe Crohn's Disease.
Phase 2
Sponsor: Pfizer
Description: The primary objectives of this study are to determine if an investigational drug called PF-06687234, is safe, tolerable, and effective as an add-on therapy to Infliximab in the treatment of patients with active ulcerative colitis.
Phase 1
Sponsor: Prometheus
Description: The primary objective of the study is to evaluate the effectiveness of an orally administered nutritional intervention (CROWN) in patients with Crohn’s Disease (CD) who are on a stable dose of an anti-TNFa medication and have incomplete healing of the intestinal mucosa. The secondary objectives of the study are to evaluate: the improvement in nutritional state, the reversal of specific amino acid deficiencies, endoscopic response, the changes in quality of life scores, and the normalization of inflammatory biomarkers (C-reactive protein [CRP] and fecal calprotectin) in patients with CD using CROWN and SOC compared to placebo and SOC.
Phase 2
Sponsor: Protagonist
Description: This study is designed to evaluate the safety/tolerability and efficacy of PTG-100 given for 12 weeks as once daily oral doses to participants with moderate to severe active UC. This data will help evaluate the optimal doses and length of treatment.
Phase 2
Sponsor: Receptos
Description: The purpose of this study is to provide a more detailed understanding of the way in which ozanimod (RPC1063) works in Crohn's disease and to begin to evaluate the effectiveness and safety as a treatment for Crohn’s disease. The study will look at how effective the study drug is at improving your symptoms and endoscopic response in Crohn’s disease (CD), and how well any improvements in your condition are maintained.
Phase 3
Sponsor: Receptos
Description: The purpose of this study is to see whether RPC1063 is safe and effective for the treatment of ulcerative colitis.
Phase 3
Sponsor: Red Hill
Description: A potential cause of Crohn's disease (CD) is infection with Mycobacterium avium subsp. paratuberculosis. RedHill Biopharma is currently enrolling the MAP US study to investigate RHB-104, a new antibiotic treatment for CD. RHB-104 combines clarithromycin, rifabutin, and clofazimine - in a novel treatment regimen for CD. These three antibiotics are active against MAP, and may provide an innovative therapeutic option to patients with CD. The purpose of the study is to investigate the efficacy and safety of 26 weeks of oral RHB-104 therapy vs. placebo in inducing remission in patients with moderately to severely active Crohn's disease.
Phase 1
Sponsor: Seres
Description: SERES-101 is a current Phase 1b clinical study evaluating the safety and efficacy of SER-287 (also known as SER-109) vs placebo, in adults with mild-to-moderate Ulcerative Colitis (UC). This study is called a Phase 1b study because it is primarily intended to assess the safety and tolerability of SER-287 when taken by adults, but it will also attempt to identify preliminary signs of efficacy in patients with UC.
Phase 3
Sponsor: Shire
Description: The goal of the PACE Study is to learn whether an investigational medication is safe and if it works well in children and adolescents aged 5 to 17 years who have mild to moderate ulcerative colitis (UC).
Survey
Sponsor: Stony Brook University
Description: The primary aims of the project are to describe levels of distress in individuals with chronic illness, and examine psychological, social, emotional, and behavioral factors that contribute to and are affected by physical symptoms.
Phase 3
Sponsor: Takeda
Description: The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Phase 3
Sponsor: Takeda
Description: The Primary Objective is to assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in patients with moderately to severely active CD who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.
Phase 3
Sponsor: Takeda
Description: The main objective of this study is to evaluate the health of the bowel at Week 26 after taking vedolizumab using ileocolonoscopy.
Open Label Extension
Sponsor: Takeda
Description: This study is designed to find out if having the medical conditions Ulcerative Colitis or Crohn’s Disease affects the way commonly used medications are broken down in the body.
Open Label Extension
Sponsor: Takeda
Description: The purpose of this study is to test the concentration of vedolizumab in the milk of breastfeeding women.
Open Label Extension
Sponsor: Takeda
Description: To determine the effect of vedolizumab IV dose optimization on mucosal healing compared with standard dosing at Week 30 in ulcerative colitis patients who have high vedolizumab clearance and who do not respond to vedolizumab at Week 6
Open Label Extension
Sponsor: The Children's Hospital of Philadelphia (CHOP) - Research Institute
Description: The purpose of this research study is to help us understand whether a diet can help children with Ulcerative Colitis (UC) to feel better without needing to take additional medications. Currently, it is thought that UC causes an imbalance in the good and bad bacteria that live inside our gut. We also know that certain foods can change how these good and bad bacteria live, and possibly contribute to UC symptoms. We think a specific diet could help create a better balance in your gut and help you feel better. This study is trying to figure out if a diet can help treat UC.
Other
Sponsor: University of Pennsylvania
Description: Crohn's & Colitis Foundation collaborates with academic and industry researchers to help enroll patients with Crohn’s disease and ulcerative colitis into clinical studies. The list below highlights our partners current research studies. Please note these partners have paid to have their trials posted below and Crohn's & Colitis Foundation does not endorse any particular study.
Phase 2
Sponsor: VHsquared
Description: To show if a new oral anti-TNF treatment has a benefit in patients with active Crohns Disease.
If you are interested in listing your trial on the Featured Research page, please contact clinicaltrials@crohnscolitisfoundation.org
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