Ulcerative Colitis Treatment Studies


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, (734) 647-2564, higginsSCteam@umich.edu

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.


TURANDOT

A double-blind, randomized, placebo-controlled, parallel, dose-ranging study to evaluate the efficacy and safety of PF-00547659 in subjects with moderate to severe ulcerative colitis

Enrollment Status: OPEN

Study Coordinator: Kelli Porzondek, (734) 764-0507, higginsSCteam@umich.edu

Drug: anti-MadCAM-1 (PF-00547659) – subcutaneous injection (under the skin)

This is a Phase 2 study to compare the effects of the study drug, anti-MadCAM-1 (PF-00547659), and placebo to find out which is better for treating ulcerative colitis (UC). This new subcutaneous biologic blocks the ability of blood vessels in the gut to attract white blood cells. This is the complement of anti-integrin therapies like vedolizumab, with injections given every 4 weeks. Patients are randomized to one of 4 doses of active drug or placebo (4:1) for 12 weeks, followed by an open label treatment for up to 52 weeks.