Ulcerative Colitis Treatment Studies

If you are looking for clinical trials for ulcerative colitis 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!


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)

This is 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: adalimubab (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).