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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.

Gastro Florida Clinical Research Trials

Crohn's Disease
  • 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.
  • Celgene: True North Not Currently Enrolling
    • 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 Not Currently Enrolling
    • 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 On Hold
    • 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.
  • Target: IBD Not Currently Enrolling
    • 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.
Gastroesophageal Reflux Disease (GERD)
  • Ironwood Not Currently Enrolling
    • NCT03561090: The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose PPIs.
Nonalcoholic Fatty Liver Disease (NAFLD) / Steatohepatitis (NASH)
  • Inventiva: NATiV3
    • NCT04849728: This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3.
  • Target:NASH
    • NCT02815891: TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)
Primary Biliary Cholangitis
  • Enanta Not Currently Enrolling
    • 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)
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).
  • 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)
  • Arena Maintenance Trial from Arena 301/210/202/210 open-label extension (OLE)
    • 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]).
  • Merk MK-7240 Not Currently Enrolling
    • A Study to Evaluate Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
  • Eli Lilly and Company AMBZ Not Currently Enrolling
    • NCT05767021 A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship With Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab
    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).