Crohn's Disease Treatment Studies

UNITI 2

Principal Investigator: Peter Higgins, MD, PhD, MSc

Enrollment Status: OPEN

Drug: Ustekinumab (Stelara®) – intravenous (IV) infusion and injection under the skin

Stelara is a medicine that blocks the activity of a protein in your body called interleukin 12/23. This protein is thought to be important in causing inflammation and therefore may play a major role in diseases like Crohn's disease and ulcerative colitis. It has already been tested and approved to treat psoriasis and psoriatic arthritis. Stelara showed promising results in previous phase II studies of patients with Crohn's disease who had not done well while taking medicines available on the market. This study, which is the next one in the series, will evaluate the effectiveness of IV infusion (given through a vein) and/or injection (given under the skin) doses of Stelara in helping to reduce symptoms in patients with moderately to severely active Crohn's disease.

Appointments are at screening, week 0 (IV infusion), week 3, week 6, and week 8. If you complete this 8-week study, you will have the option to join the maintenance phase of the study, which will allow access to the drug for up to 4 years. This will involve returning to the site every 4 weeks for an injection under the skin. You will be reimbursed $50 for each completed appointment.

TRUST 1

Principal Investigator: Peter Higgins, MD, PhD, MSc

Enrollment Status: OPEN

Drug: Trichuris suis ova (TSO) – oral medicine

The University of Michigan is looking for people with Crohn's disease to participate in a clinical research study examining a new type of probiotic. Highly clean environments in developed countries reduce exposure to germs and parasites. Some scientists think this lack of exposure may trigger responses in the body that make people more susceptible to diseases in which a person's immune system could cause damage to its own tissues and internal organs (e.g.,Crohn's disease). People in nonindustrial countries and the tropics where parasites are common rarely develop this type of disease.

This study is evaluating an investigational biological study product that is a new approach to treating Crohn's disease based on the ideas above. This study will examine the safety, effectiveness, and tolerability of Trichuris suis ova (TSO), a type of probiotic, compared to placebo in people who have Crohn's disease. TSO are the eggs of a very small worm called a "helminth." TSO were chosen because they are not a human parasite, and can't live for more than a few weeks in your body. After being swallowed, TSO’s temporary presence in the gut causes a reaction from your immune system. The researchers doing this study think that the TSO may "distract" your body so that it fights the worm and possibly won't "attack" the person's body anymore. Early clinical trials show that TSO may be effective in treating active Crohn's disease.

Appointments are at screening, screening colonoscopy, week 0, week 2, and every 2 weeks from there on, for 24 weeks. If you complete all visits, you will receive up to $1,385.00 compensation for your time and travel.

PEBBLE

Principal Investigator: Peter Higgins, MD, PhD, MSc

Enrollment Status: OPEN

Drug: MEDI-2070 – intravenous (IV) infusion and injection under the skin

The PEBBLE Program is a clinical research study being conducted worldwide to test the effectiveness of MEDI-2070 in people who have Crohn's disease. MEDI-2070 blocks a type of protein called interleukin-23 (IL-23). This protein is thought to be important in causing inflammation and therefore may play a major role in Crohn's disease. A recent study showed that MEDI2070 helps patients with a skin disease called psoriasis, another disease where IL-23 is thought to play a major role. MEDI2070 may help decrease inflammation in the gastrointestinal tract of patients with Crohn's disease.

If you decide to take part, you will first complete the induction phase. For this, you will be asked to visit the study center 6 times over the 12-week study period. At weeks 0, 2, 4, 8, and 12, you will return to the site to complete a routine check-up and receive a dose of the study medicine in an IV (week 0 and 4 only). This will include collection of laboratory tests (blood, urine, and stool), a weight check, and a physical examination. On some occasions you may also need to complete forms or questionnaires.

If you complete this study, you will have the option to join the open-label phase of the study, which will allow access to the drug for up to 2 years. This will involve returning to the site every 4 weeks for an injection under the skin. There is no placebo involved in this portion of the study. You will be reimbursed $90 for each visit completed.

CADHUM

Principal Investigator: Peter Higgins, MD, PhD, MSc

Enrollment status: OPEN

This study will determine if Crohn's patients in remission, with a fecal calprotectin <167, can safely stop Humira® therapy for up to 48 weeks, and if this state can be safely monitored with biomarkers of inflammation with no further therapy. If and when elevations in biologic biomarkers occur, Humira® therapy will be restarted as needed.

SHIELD

Principal Investigator: Peter Higgins, MD, PhD, MSc

Enrollment Status: CLOSED

Drug: GSK 1605786A – oral medication

This study will assess the effectiveness of a new compound, GSK1605786A, compared to placebo as an induction therapy for Crohn's patients over 12 weeks. This is an orally administered chemokine antagonist that specifically blocks the migration of gut-specific T cells, which selectively home to the intestine.

Subjects will return every 2 weeks over the 12-week treatment period. Every other visit is simply a blood draw to monitor drug response. 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 lasting 52 weeks (CCX115157). 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 (CCX114644) where they will be given the study drug for 2 years.

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