Clinical Research Trials

Gastro Florida offers clinical research trials in which volunteers participate and receive a trial treatment for a particular condition while under supervision. There are multiple advantages for participating in a clinical research trial. They include:

  • Access to the latest treatments before they are widely available
  • Therapeutic options when other methods have not worked
  • Playing an active role in your health care
  • Help others by contributing to science and research
  • Research may lead to better treatment of their condition
  • No monetary cost to the patient

 

Please contact Gastro Florida’s Lead Clinical Research Coordinator, Shannon Brewington at This email address is being protected from spambots. You need JavaScript enabled to view it. for more information about the active trials listed below.

Active Trials

Crohn’s Disease

Genentech: Bergamot

GA29144: A phase III, 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.

Pfizer: Pizzicato

B7981007: A phase 2a, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy and safety of oral Pf-06651600 and Pf-06700841 as induction and open label extension treatment in subjects with moderate to severe Crohn's Disease.

Janssen: Seavue

CNTO1275CRD3007: A phase 3b, multicenter, randomized, blinded, active-controlled study to compare the efficacy and safety of ustekinumab to that of adalimumab in the treatment of biologic naïve subjects with moderately-to-severely active Crohn’s disease.

Celgene: True North

RPC01-3201: Induction study #1- a phase 3, multicenter, randomized, double-blind, placebo-controlled study of oral ozanimod as induction therapy for moderately to severely active Crohn’s disease.

Shire: Carmen

SHP647-305: A phase 3, double-blind, placebo-controlled, parallel-group, randomized, study of SHP647 as an induction therapy in subjects with moderate to severe Crohn’s Disease

Takeda

Vedolizumab-4006: An open-label, phase 4 study to evaluate the efficacy and safety of triple combination therapy with vedolizumab IV, adalimumab SC, and oral methotrexate in early treatment of subjects with Crohn's disease stratified at higher risk for developing complications

Gastroesophageal Reflux Disease (GERD)

Ironwood

C3718-301: A phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial of oral IW-3718 administered to patients with Gastroesophageal Reflux Disease while receiving proton pump inhibitors

Inflammatory Bowel Disease (IBD)

Target

Target-IBD: A 5-year longitudinal observational study of patients undergoing therapy for Inflammatory Bowel Disease

Nonalcoholic Fatty Liver Disease (NAFLD)/Steatohepatitis (NASH)

Prometheus

16HEP01: Procurement of blood samples from subjects with diagnosed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) for use in the development of a liver fibrosis test

Tobira: Aurora

Protocol 3152-301-002: A phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of cenicriviroc for the treatment of Liver Fibrosis in adult subjects with nonalcoholic steatohepatitis

Primary Biliary Cholangitis

Enata

A phase 2 dose ranging, randomized, double blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and efficacy of EDP-305 in subjects with primary biliary cholangitis (PBC) with or without an inadequate response to ursodeoxycholic acid (UDCA))

GlaxoSmithKline: Study 201000

A randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis. (GLIMMER: GSK2330672 trial of Ibat inhibition with Multidose Measurement for Evaluation of Response)

Target

Target-PBC: A 5-year longitudinal observational study of patients with Primary Biliary Cholangitis

Ulcerative Colitis

Allergan

3151-201-008: A 54-week treatment, multicenter, randomized, double-blind, double-dummy, placebo and active-controlled, parallel-group phase 2 study to assess the efficacy and safety of brazikumab in participants with active, moderate to severe Ulcerative Colitis

Celgene

A phase III, multicenter, randomized, double-blind, placebo-controlled trial of oral RPC1063 as induction and maintenance therapy for moderate to severe Ulcerative Colitis

Eli Lilly: Lucent

I6T-MC-AMAN: A phase 3, multicenter, randomized, double-blind, parallel, placebo-controlled induction study of mirikizumab in conventional-failed and biologic-failed patients with moderately to severely active Ulcerative Colitis

Genentech: Hickory

GA28950: Safety of etrolizumab during induction and maintenance in patients with moderate to severe active Ulcerative Colitis who are refractory to or intolerant of TNF inhibitors.

Genentech: Laurel

GA29102: Etrolizumab compared with placebo in patients with moderate to severe active Ulcerative Colitis who are naïve to TNF inhibitors.

AbbVie: Serene

M14-033: 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

Pfizer: Vibrato

B7981005: A phase 2b, double-blind, randomized, placebo-controlled, parallel group, dose ranging study of oral Pf-06651600 And Pf-06700841 as induction and chronic therapy in subjects with moderate to severe Ulcerative Colitis

Seres

SERES-101: A phase 1b multiple dose study to evaluate the safety, tolerability and microbiome dynamics of SER-287 in subjects with mild-to-moderate Ulcerative Colitis

Shire: Figaro UC 302

SHP647-302: A Phase III randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study of SHP647 as induction therapy in subjects with moderate to severe Ulcerative Colitis

Takeda

Vedolizumab-4014: A phase IV open-label study to evaluate Vedolizumab IV dose optimization on treatment outcomes in non-responders with moderately to severely active Ulcerative Colitis.