Crohn's Disease Treatment Studies

If you are looking for clinical trials for Crohn's disease you have come to the right place! As researchers, our goal is to discover new therapies and information about Inflammatory Bowel Disease (IBD), but most importantly, provide an alternate therapy that helps YOU. We welcome you to the IBD Research Team and encourage you to look at the studies below that you may qualify for. We will update this site periodically, so keep checking this page for new studies. If you have ANY questions or are interested in participating please feel free to call (734) 615-4843 or e-mail higginsSCteam@umich.edu. We hope to hear from you soon!


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 (anti-integrin β7), 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 β7 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

A phase 2b double-blind, multi-dose, placebo-controlled 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 (TNF-α) therapy

Enrollment status: OPEN

Study Coordinator: Kimberly Brunette

Drug: MEDI2070, infusion and injection under the skin

Target: anti–IL-23

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.


Pioneer

A randomized, double-blind, placebo-controlled trial to evaluate the effectiveness of a nutritional intervention in improving the intestinal mucosal health status in subjects with Crohn’s disease (CD) receiving induction anti-TNF therapy

Enrollment status: OPEN

Study Coordinator: Angela Theil

Nutritional study

This study is to evaluate the effectiveness of an orally administered medical food in moderately to severely active subjects receiving induction therapy for Remicade® or Humira®.


Revolve

A phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn's disease

Enrollment status: OPEN

Study Coordinator: Kelli Porzondek

Drug: GED-0301 (mongersen); oral

Target: antisense for SMAD7 mRNA

Phase 3: 52 weeks, placebo-controlled, double-blind period. Maximum 3 previous biologics.