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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
  • SIBERITE-1
    • NCT06819878: This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn’s disease (CD).
  • Panorama TAK-4063
    • NCT06581328: A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn’s Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting.
  • 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.
  • Abivax: Obefazimod
    • NCT06456593: The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies.
  • Merck Sharp: MK-7240 On Hold
    • NCT06430801: The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn’s disease.
  • Takeda: TAK-279 Not Currently Enrolling
    • NCT06233461: Crohn’s disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn’s disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation.
  • Teva: TEV-48574 Not Currently Enrolling
    • NCT05668013: The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD).
  • 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: This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn’s disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.
  • 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 Not Currently Enrolling
    • NCT02815891: TARGET-NASH is a longitudinal observational cohort study of patients being managed for NASH and related conditions across the entire spectrum NAFLD in usual clinical practice. TARGET-NASH is a research registry of patients with NAFL or NASH within academic and community real-world practices maintained in order to assess the safety and effectiveness of current and future therapies.
Primary Biliary Cholangitis
  • Enanta Not Currently Enrolling
    • NCT03394924: 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
  • Ametrine-1
    • NCT06589986: This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
  • Panorama TAK-4063
    • NCT06581328: A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn’s Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting.
  • 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].
  • Amgen Not Currently Enrolling
    • 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 Not Currently Enrolling
    • 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.
  • Pfizer: Etrasimod Not Currently Enrolling
    • NCT06398626: The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod.
  • 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 Not Currently Enrolling
    • NCT02536404: The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.
  • Merk MK-7240 On Hold
    • NCT06052059: 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: RESTORATiVE303
    • The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
  • Vedanta Not Currently Enrolling
    • NCT03788434: This study will evaluate the safety and efficacy of VE303 for participants with recurrent Clostridium difficile infection (rCDI).
Cirrhosis
  • Bausch: RNLC3132 Not Currently Enrolling
    • NCT05297448: Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.
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