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.


LILLY

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

Enrollment status: OPEN

Study Coordinator: Jennifer Dixon

Drug: LY3074828 (anti–IL-23); infusion and injection under the skin

Target: anti–IL-23

A 12-week induction period is designed to establish the efficacy and safety of LY3074828 administered intravenously (IV) at weeks 0, 4, and 8. Subjects will be stratified across the treatment arms on the basis of previous exposure to biologic therapy for treatment of UC. Subjects who discontinue the study for any reason before the end of the induction period will complete the induction period early termination visit.

The maintenance period is designed to explore the safety and durability of clinical responses and remissions to treatment with 200-mg LY3074828 administered subcutaneously (SC) every 4 weeks (Q4W) or every 12 weeks (Q12W). Subjects defined as having clinical responses at week 12 will continue study participation in the maintenance period up to week 104. Subjects who do not meet clinical response criteria at week 12 will have the option to continue in a study extension period or discontinue from the study.

Responding subjects who have received LY3074828 in the induction period will be re-randomized to 1 of 2 LY3074828 maintenance treatment arms (200 mg Q4W or 200 mg Q12W); these subjects will be stratified according to their week-12 remission status. Any responding subjects in the placebo arm SC Q4W will remain on placebo. After week 52, subjects who experience worsening of UC (partial Mayo score of 7 or more) may receive rescue treatment with LY3074828 200 mg SC Q4W. Subjects who discontinue the study for any reason during the maintenance period will complete the maintenance period early termination visit.

If enrolled in the study, patients have the ability to receive free drug for up to 92 weeks.


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.


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

Target: S1P1R1 activator

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

A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter protocol to evaluate the safety and efficacy of ustekinumab induction and maintenance therapy in subjects with moderately to severely active ulcerative colitis

Enrollment status: OPEN

Study Coordinator: Angela Theil

Drug: ustekinumab (Stelara®); infusion and injection under the skin

Target: anti–IL-23

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).


UpStart (Lycera UC)

A randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of induction therapy with LYC-30937-EC in subjects with active ulcerative colitis

Enrollment status: OPEN

Study Coordinator: Jennifer Dixon

Drug: Lyc-30937-EC; oral

Target: ATPase modulator

The objective of this study is to evaluate the efficacy, safety, and tolerability of LYC-30937-EC compared to placebo in subjects with UC. In addition, selected pharmacokinetic (PK) and pharmacodynamic (PD) parameters will be assessed. Subjects who complete the double-blind portion of the trial through week 8 will have the option of receiving open-label treatment with LYC-30937-EC in a separate open-label extension study (LYC-30937-2002), which will have the objective of collecting long-term safety data on LYC-30937-EC in subjects with active UC.