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!


Hibiscus

A phase 3, randomized, double-blind, double-dummy, placebo-controlled, multicenter study to evaluate the efficacy (induction of remission) and safety of etrolizumab compared with adalimumab and placebo in patients with moderate to severe ulcerative colitis who are naïve to TNF inhibitors.

Enrollment Status: OPEN

Study Coordinator: Kay Sauder

Drug: Etrolizumab (anti-integrin β7) – subcutaneous injection (under the skin); adalimumab (Humira®) – subcutaneous injection

This is a phase 3 study for patients with moderate to severely active ulcerative colitis who have failed or who are intolerant of immunosuppressant treatment (azathioprine, methotrexate, 6-MP) but have not tried anti-TNF medications (Remicade®, Humira®, Simponi®). There are 2 possible study medicines that patients will be assigned to: etrolizumab and adalimumab. 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. Adalimumab is an anti-TNF medicine currently approved for the treatment of ulcerative colitis, Crohn's disease, and other autoimmune diseases.

The study lasts up to 14 weeks and involves a screening visit, baseline enrollment visit, and follow-up drug administration visits every 2–4 weeks. Patients are also required to have a colonoscopy done at screening and week 10 to assess disease activity and response to the study medicine. Patients who enroll in the study will be randomly assigned to etrolizumab, adalimumab, or placebo (inactive medicine). All patients have a 20% chance of receiving placebo. After completing the Hibiscus study, patients will have the option to roll over to the open-label portion of the study, known as Cottonwood, and receive active study medicine for up to 7 years or until the study medicine is approved by the FDA.


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.


OCTAVE

A multicentre, randomized, double-blind, placebo-controlled, parallel group study of oral CP-690,550 (JAK inhibitor) as an induction therapy in subjects with moderate to severe ulcerative colitis

Enrollment Status: OPEN

Study Coordinator: Kay Sauder

Drug: Tofacitinib (CP-690,550) – oral medication

This is a phase 3 study of subjects with moderately to severely active ulcerative colitis. The medicine is a JAK inhibitor made by Pfizer. JAK inhibition is a novel approach for treating a variety of autoimmune and inflammatory diseases. JAK inhibitors interrupt signaling downstream of a multiplicity of cytokines, rather than blocking one cytokine at a time, as occurs with anti-TNF or interleukin-6 blockers. It is taken in pill form.

The study lasts 9 weeks and involves a screening visit, a week 0/baseline appointment, and follow-up visits at week 2, week 4, and week 8 to assess response to the medicine. Finally, at week 9 we will assess the subject's eligibility to continue in the program. Those who complete the treatment period and meet the definition of clinical response or clinical remission will be eligible to enter a placebo-controlled maintenance study of 52 weeks (A3921096). Subjects who complete the treatment period but do not meet the definition of clinical response or remission will be eligible to enter an open-label extension study (A3921139), meaning there is no placebo and you are guaranteed active drug.


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: Karina Lizzi

Drug: 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.