Troy Gastroenterology PC

Center for Digestive Health

248-267-8485

Visit the Patient Portal

Clinical Trials

Crohn's Disease Treatments

Crohn's disease is an inflammatory bowel disease (IBD). It causes inflammation of the lining of your digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. Inflammation caused by Crohn's disease can involve different areas of the digestive tract in different people. If you are struggling to find a treatment that works for you contact us to see what alternative therapies we have to offer.

Bergamot

Back to top

A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of etrolizumab as an induction and maintenance treatment for patients with moderately to severely active Crohn's disease

Enrollment Status: OPEN
Drug: Etrolizumab (beta7 anti-integrin) subcutaneous injection

This is a phase 3 study for patients with moderate to severely active Crohn's disease to evaluate the safety and effectiveness of etrolizumab, a beta7 anti-integrin that acts on the lining of the gut to block white blood cell trafficking. The study lasts up to 72 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 72 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 Bergamot study, patients have the option to roll over into the open-label portion of the study known as Juniper, and receive active study medication for up to 6 years or until the medication is approved by the FDA.


Juniper

Back to top

An open-label extension and safety monitoring study of patients with moderately to severely active Crohn’s disease previously enrolled in the etrolizumab Phase III Protocol GA29144

Enrollment Status: OPEN
Drug: Etrolizumab (beta7 anti-integrin) subcutaneous injection

This is a phase 3 study for patients with moderate to severely active Crohn's disease to evaluate the safety and effectiveness of etrolizumab, a beta7 anti-integrin that acts on the lining of the gut to block white blood cell trafficking. Patients receiving etrolizumab or placebo in Study GA29144 (Bergamot) may be eligible to participate and will receive etrolizumab in Part 1 open label extension (OLE). The study is designed to assess the long-term safety and tolerability of 105 mg SC etrolizumab every four weeks with regard to adverse events and laboratory abnormalities and to obtain long-term data on the efficacy and immunogenicity. Part 2 is a 92 week safety monitoring for all patients during which no etrolizumab will be administered.


MedImmune

Back to top

A Phase 2b study to evaluate the efficacy and safety of MEDI2070 in subjects with moderate to severe Crohn’s disease who have failed or are intolerant to Anti Tumor Necrosis Factor- Alpha Therapy

Enrollment Status: OPEN
Drug: MEDI2070 IV infusion and subcutaneous injections, after week 8 subcutaneous injections

This is a four-part Phase 2b study comprised of a 16-week, double-blind, placebo-controlled, Induction Period, a 12-week double-blind, placebo-controlled, Maintenance Period, a 24-week, Open-Label Period and a post-treatment 28 week observational safety follow-up period designed to evaluate the short-term efficacy and the short- and long term safety of MEDI2070 in subjects with moderate to severe, active Crohn’s disease who have failed or are intolerant to Anti Tumor Necrosis Factor-Alpha therapy as determined by the Investigator.


RedHill

Back to top

A randomized, double-blind, placebo-controlled, multicenter, parallel group study to assess the efficacy and safety of fixed-dose combination RHB-104 in subjects with moderately to severely active Crohn’s disease

Enrollment Status: OPEN
Drug: Clarithromycin, Rifabutin, and Clofazimine

This study is a multicenter, Phase 3, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of RHB-104 compared to placebo to treat subject with moderate to severe CD. RHB-104 consists of 3 antibiotics with activity against Mycobacterium avium subsp. paratuberculosis (MAP), a potential cause of CD. The study is designed to assess remission at Week 26. The study is designed to assess response, remission, and maintenance of remission in subjects on randomized treatment through week 52.


Ulcerative Colitis Treatments

Ulcerative Colitis disease is an inflammatory bowel disease (IBD) that causes long-lasting inflammation and ulcers (sores) in your digestive tract. Ulcerative colitis affects the innermost lining of your large intestine (colon) and rectum. Symptoms usually develop over time, rather than suddenly. If you are struggling to find a treatment that works for you contact us to see what alternative therapies we have to offer.

Hickory/Cottonwood

Back to top

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

Enrollment Status: OPEN
Drug: Etrolizumab (anti-integrin β7) - subcutaneous injection

This is a Phase 3 study for patients with moderate to severely active ulcerative colitis who have failed or been intolerant to infliximab (Remicade®) and/or adalimumab (Humira). 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 or failed to respond to treatment, 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.


Hibiscus

Back to top

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

Enrollment Status: OPEN
Drug: Etrolizumab (anti-integrin β7) - subcutaneous injection

This is a multicenter, Phase 3, randomized, double-blind, double-dummy, placebo and active comparator controlled study to evaluate the safety, efficacy, and tolerability of etrolizumab (105 mg SC Q4W) in the induction of remission for patients naive to TNF inhibitors. Comparisons will be made against placebo and adalimumab (160 mg SC Week 0, 80 mg SC Week 2, 40 mg SC Weeks 4, 6, and 8). The study design is double-blind, double-dummy, placebo-controlled so all patients will receive two study treatments: active etrolizumab + adalimumab placebo, active adalimumab + etrolizumab placebo, or etrolizumab placebo + adalimumab placebo. The study will be divided into a screening period of up to 28 days, double-blind treatment period of up to 14 weeks, which consists of a 10-week induction period and an additional 4-week treatment period for patients who meet the definition of clinical remission at Week 10 and a safety follow-up period of 12 weeks. An extended safety-monitoring period of an additional 92 weeks (after 12-week safety follow-up) for PML will be conducted in an OLE and safety monitoring (OLE-SM) study under a separate protocol.


Celgene

Back to top

A Phase 2, randomized, placebo-controlled, multi-center study to investigate the efficacy and safety, of Apremilast (CC-10004) for treatment of subjects with active ulcerative colitis

Enrollment Status: OPEN
Drug: Apremilast (CC-10004)

Eligible subjects will enter the double-blind, placebo-controlled phase at the baseline visit (Week 0/Visit 2). Subjects will be randomly assigned to study treatments: apremilast (30 mg twice daily [BID], 40 mg BID), compared with placebo. Following 12 weeks of treatment, subjects who do not achieve an at least 20% decrease from baseline in the TMS will be considered to be "nonresponders" and will receive apremilast 40mg BID for an additional 8 weeks . In order to determine non-responders, the endoscopy sub-score assessed by the investigator will be used for the calculation of the Week 12 TMS. (Non-responders initially assigned placebo or apremilast 30 mg BID at baseline will be reassigned/switched to apremilast 40 mg BID; Non-responders initially assigned apremilast 40 mg BID will continue to receive apremilast 40 mg BID). Non-responders who were initially randomized to placebo will be dose-titrated in 10-mg/day increments over the first 8 days of apremilast 40 mg BID treatment, beginning at the Week 12 Visit. Subjects who achieve an at least 20% decrease from baseline in the TMS at Week 12 will continue to receive the blinded treatment assigned at baseline for an additional 8 weeks. Post-treatment observational follow-up phase - Weeks 20 to 24 subjects who complete the double-blind placebo-controlled phase, as well as subjects who prematurely discontinue from study, for any reason, will enter the post-treatment observational follow-up phase, the 4-week period after the last dose of IP.


UNIFI

Back to top

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
Drug: Ustekinumab (Stelara) IV infusion induction followed by subcutaneous injections every 4 weeks

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, protocol of ustekinumab. The protocol will consist of 2 studies: an Induction study and a Maintenance study with unique endpoints. Screening period will be up to 8 Weeks. Induction study will be at least 8 weeks duration for each participant. Participant with clinical response in the Induction study will be eligible for the maintenance study. The maintenance study will be 44 weeks duration. After completion of the maintenance study, a long term extension will follow eligible participants for an additional 3 years. Clinical remission will be evaluated at Week 8 in the induction study. Clinical remission among ustekinumab induction responders will be evaluated at week 44 in the Maintenance study. Participants' safety will be monitored throughout.


Our Research Sponsors

We work with the following pharmaceutical companies:

Sponsors


© 2017 Troy Gastroenterology PC, All Rights Reserved

248-267-8485

Ready Rating Member Seal

Website Terms & Conditions