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Clinical Research

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

For more information about the active trials listed below, please e-mail research@gastrofl.com or call (727) 347-0005 and choose option 3.

Active Trials

Crohn's Disease
  • Celgene: True North
    • NCT03440372: This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn’s Disease.
  • Arena Cultivate
    • NCT04173273: A multicenter, randomized, double-blind, parallel-group study to assess the efficacy and safety of oral etrasimod as induction and maintenance therapy for moderately to severely active Crohn’s Disease.
  • Takeda: Compass
    • NCT04809363: CDPATH™ is a tool to help predict the potential for developing Crohn’s disease related complications in certain adult participants within 3 years. The main aim of the study is to explore the use of CDPATH™ to describe a participant’s risk profile and to have discussions with their doctor about the potential path of their Crohn’s disease. The number of visits will be decided by the study clinic according to their standard practice.
  • Janssen: Galaxy
  • Abivax
    • NCT05535946: This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].
  • Janssen: Graviti
    • NCT05197049: Crohn’s disease is a chronic, progressive and potentially life-threatening disorder which may affect any part of the gastrointestinal (GI) tract. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody that binds to human interleukin (IL)-23, thereby blocking the binding of extracellular IL-23 to the cell surface IL-23 receptor. This binding results in inhibition of IL-23 mediated intracellular signaling, activation and cytokine production. The purpose of the study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease. The overall study duration is up to 109 weeks.
  • Target: IBD
    • NCT03251118: TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.
  • Genentech: Bergamot Not Currently Enrolling
    • NCT02394028: This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderate to severely active CD in participants who are refractory or intolerant to corticosteroids (CS), immunosuppressants (IS), or anti-tumor necrosis factors (anti-TNFs) or have inadequate response to anti-tumor necrosis factor (TNF-IR). Participants who enroll on the basis of refractory or intolerance to CS and/or IS may have been previously exposed to anti-TNFs or be naïve to anti-TNFs. The study period will consist of Screening Phase (up to 35 days) plus (+) 14-week Induction Phase + 52-week Maintenance Phase + 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving decrease of 70 points in Crohn’s Disease Activity Index (CDAI) from baseline (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.
  • Pfizer: Pizzicato Not Currently Enrolling
    • NCT03395184: The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.
  • AstraZeneca Not Currently Enrolling
    • NCT03759288: A 52-week, multicenter, randomized, double-blind, double-dummy, placebo and active-controlled, operationally seamless phase 2b/3, parallel-group study to assess the efficacy and safety of brazikumab in participants with moderately to severely active Crohn’s Disease.
  • Bristol-Myers Not Currently Enrolling
    • IM011023: A Phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of BMS-986165 in subjects with moderate to severe Crohn’s Disease
  • Eli Lilly Not Currently Enrolling
    • NCT03926130: A phase 3, multicenter, randomized, double-blind, placebo- and active- controlled, treat-through study to evaluate the efficacy and safety of mirikizumab in patients with moderately to severely active Crohn’s Disease.
Gastroesophageal Reflux Disease (GERD)
  • Celgene
    • NCT04753697: A phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC-93538 in adult and adolescent participants with eosinophilic esophagitis.
  • Arena Voyage Not Currently Enrolling
    • NCT04682639: A Phase 2 randomized, double-blind, placebo-controlled study to assess the safety and efficacy of etrasimod in adult subjects with eosinophilic esophagitis.
Nonalcoholic Fatty Liver Disease (NAFLD) / Steatohepatitis (NASH)
  • Pfizer
    • NCT04321031: A phase 2, randomized, double-blind, double-dummy, placebo-controlled, dose-ranging, dose-finding, parallel group study to assess efficacy and safety of pf-06865571 (DGAT2i) alone and when coadministered with pf-05221304 (ACCi) in adult participants with biopsy-confirmed nonalcoholic steatohepatitis and fibrosis stage 2 or 3.
  • Inventiva: NATiV3
    • NCT04849728: This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3
  • Sagimet Not Currently Enrolling
    • NCT04906421: This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy on TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH). Subjects will be randomly assigned toTVB-2640 or matching placebo PO QD for 52 weeks, with the first dose administered on Day 1.
Primary Biliary Cholangitis
  • Target: PBC Not Currently Enrolling
    • NCT02932449: This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.
Ulcerative Colitis
  • Amgen
    • NCT04987307: The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC).
  • Bristol-Myers
    • NCT05369832: The purpose of this study is to explore the safety, efficacy, quality of life, and biomarker response in participants with moderate to severe ulcerative colitis in clinical practice.
  • Janssen Astro
    • NCT05528510: The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
  • Adiso
    • NCT04891965: This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent C. difficile infection (CDI) who have completed a standard of care course of CDI antibiotics and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug.
  • Abivax Abtect
    • NCT05507216: This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].
  • Teva Relieve
    • NCT05499130: The primary objective is to evaluate the efficacy and dose response of 3 different dose regimens of TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn’s Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD).
  • Shire Not Currently Enrolling
    • NCT03283085: The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn’s disease (CD)
  • AstraZeneca Not Currently Enrolling
    • PLC D5271C00001 EXT 201: A 52-week, multicenter, randomized, double-blind, double-dummy, placebo and active-controlled, operationally seamless phase 2b/3, parallel-group study to assess the efficacy and safety of brazikumab in participants with moderately to severely active ulcerative colitis.
  • Pfizer: Vibrato Not Currently Enrolling
    • NCT02958865: The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.
  • Arena Not Currently Enrolling
    • NCT03950232: The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).
  • Pfizer Tuscany (Greenphire) Not Currently Enrolling
    • NCT04090411: A phase 2b, multicenter, randomized, double-blind, placebo-controlled dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics of PF-06480605 in adult participants with moderate to severe ulcerative colitis.
  • Arena Gladiator Not Currently Enrolling
    • NCT04607837: A randomized, double-blind, placebo-controlled, 52-week study to assess the efficacy and safety of etrasimod in subjects with moderately active ulcerative colitis.
C-Diff
  • Vedanta Not Currently Enrolling
    • NCT03788434: This study will evaluate the safety and efficacy of VE303 for participants with recurrent Clostridium difficile infection (rCDI).
  • Seres Not Currently Enrolling
    • 013: Ecospor IV: an open-label extension of study seres-012 and open-label program for evaluating ser-109 in adult subjects with recurrent Clostridioides difficile infection (rCDI)