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; subcutaneous injection (under the skin)

Target: anti-integrin β7

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.


ABT-494 – upadacitinib

Phase 2b/3 study to evaluate the safety and efficacy of upadacitinib in subjects with moderate to severe ulceerative colitis.

Enrollment status: ON HOLD UNTIL AUGUST 2018

Study Coordinator: TBA

Drug: oral tablet


Figaro

A phase 2, multicenter, randomized, double-blind, parallel, placebo-controlled study of LY3074828 in subjects with moderate to severe ulcerative colitis

Enrollment status: OPEN

Drug: injection under the skin

Eligible subjects will go through a 12-week induction, 52-week maintenance, and a long-term open label until the drug is approved by the FDA.


M14-234

A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of ABT-494 for induction and maintenance therapy in subjects with moderately to severely active ulcerative colitis

Enrollment status: OPEN

Study Coordinator: Jennifer Dixon

Drug: ABT494; oral

Target: JAK1

This is a phase 2b/3 study designed to evaluate the safety and effectiveness of ABT-494 in patients with moderate to severe ulcerative colitis.The induction for this study is 8 weeks, with a  44-week maintenance period. There is also an open label extension to follow so all enrolled subjects will have the opportunity to be placed on the drug.

Study M14-234 comprises three substudies.