Gastroenterology & Hepatology Clinical Trials | NYU Langone Health

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Division of Gastroenterology & Hepatology Research Gastroenterology & Hepatology Clinical Trials

Gastroenterology & Hepatology Clinical Trials

NYU Langone’s Division of Gastroenterology and Hepatology offers patients opportunities to take part in clinical trials, providing access to studies evaluating novel new treatments and approaches to many gastrointestinal and liver diseases and conditions. Learn more about participating in a clinical trial or research study at NYU Langone as a patient or explore our resources for researchers and study teams.

The following trials are currently open for patient enrollment.

Inflammatory Bowel Disease

Researchers in the Division of Gastroenterology and Hepatology are recruiting patients for the following clinical trials in inflammatory bowel disease, including the two most common subtypes: Crohn’s disease and ulcerative colitis.

Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron to Treat Iron Deficiency Anaemia in IBD

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal investigator: Lev Ginzburg, MD

Crohn’s Disease

Filgotinib in the Induction and Maintenance of Remission in Adults with Moderately to Severely Active Crohn’s Disease

For information about participating in this trial, including eligibility criteria, email Gregory Pappas at gregory.pappas@nyulangone.org or Christopher Hawryluk at christopher.hawryluk@nyulangone.org. See full clinical trial information.

Principal investigator: David P. Hudesman, MD

A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

For information about participating in this trial, including eligibility criteria, email Gregory Pappas at gregory.pappas@nyulangone.org or Christopher Hawryluk at christopher.hawryluk@nyulangone.org. See full clinical trial information.

Principal investigator: David P. Hudesman, MD

Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn’s Disease (DINE-CD)

For information about participating in this trial, including eligibility criteria, email Gregory Pappas at gregory.pappas@nyulangone.org or Christopher Hawryluk at christopher.hawryluk@nyulangone.org. See full clinical trial information.

Principal investigator: David P. Hudesman, MD

Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects with Moderate to Severe Crohn's Disease

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal investigator: Blanche Fung Liu, MD

A Study to Assess Whether Etrolizumab is a Safe and Effective Treatment for Participants with Moderately to Severely Active Crohn’s Disease (CD)

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal investigator: Robert E. Tepper, MD

Safety and Efficacy Study of JnJ-64304500 in Participants with Moderately to Severely Active Crohn’s Disease (TRIDENT)

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal investigator: Seymour Katz, MD

A Study of Mirikizumab (LY3074828) in Participants with Active Crohn’s Disease (SERENITY)

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal investigator: Lev Ginzburg, MD

Triple Combination Therapy in High Risk Crohn’s Disease

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal investigator: Seymour Katz, MD

A Randomized, Double-Blind Multidose, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Efficacy of IMO-9200 Versus Placebo in Subjects with Active Crohn’s Disease

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org.

Principal investigator: Blanche Fung Liu, MD

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal investigator: Lev Ginzburg, MD

Ulcerative Colitis

Study to Compare Oral Pf-06651600, Pf-06700841, and Placebo in Subjects with Moderate to Severe Ulcerative Colitis

For information about participating in this trial, including eligibility criteria, email Gregory Pappas at gregory.pappas@nyulangone.org or Christopher Hawryluk at christopher.hawryluk@nyulangone.org. See full clinical trial information.

Principal investigator: David P. Hudesman, MD

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

For information about participating in this trial, including eligibility criteria, email Gregory Pappas at gregory.pappas@nyulangone.org or Christopher Hawryluk at christopher.hawryluk@nyulangone.org. See full clinical trial information.

Principal investigator: David P. Hudesman, MD

A Study Comparing the Efficacy and Safety of Etrolizumab with Adalimumab and Placebo in Participants with Moderate to Severe Ulcerative Colitis (UC) Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #1)

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal investigator: Seymour Katz, MD

Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects with Moderate to Severe Ulcerative Colitis

For information about this trial, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal investigator: Blanche Fung Liu, MD

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal Investigator: Seymour Katz, MD

Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal Investigator: Blanche Fung Liu, MD

Efficacy, Safety, and Tolerability of PF-06687234 as Add-On Therapy to Infliximab in Active UC Subjects Not in Remission

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal investigator: Seymour Katz, MD

A Randomized, Double-Blind Multidose, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Efficacy of IMO-9200 versus Placebo in Subjects with Active Ulcerative Colitis

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org.

Principal investigator: Blanche Fung Liu, MD

GSK2982772 Study in Subjects with Ulcerative Colitis

For information about participating in this trial, including eligibility criteria, email Heather Dufficy Lampone at heather.dufficylampone@nyulangone.org. See full clinical trial information.

Principal investigator: Seymour Katz, MD

Liver Disease

Our researchers who study liver disease are recruiting patients for the following clinical trials in hepatitis C, hepatocellular carcinoma, primary biliary cholangitis, nonalcoholic steatohepatitis, nonalcoholic steatohepatitis with cirrhosis, and nonalcoholic steatohepatitis with fibrosis.

Hepatitis C

Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients (SMART-C)

For information about this trial, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org. See full clinical trial information.

Principal investigator: Ira M. Jacobson, MD

Study of Oral Treatments for Hepatitis C (PRIORITIZE)

For information about this trial, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org. See full clinical trial information.

Principal investigator: James S. Park, MD

Multicenter, Randomized, Open-Label Study of G/P +/− RBV for NS5A + SOF Previously Treated GT1 HCV Subjects

For information about participating in this trial, including eligibility criteria, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org. See full clinical trial information.

Principal investigator: James S. Park, MD

Hepatocellular Carcinoma

Genome Studies of Hepatocellular Carcinoma Developed in Hepatitis C Patients with Sustained Virological Response (HEPCASUS)

For information about participating in this trial, including eligibility criteria, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org. See full clinical trial information.

Principal investigator: James S. Park, MD

Primary Biliary Cholangitis

Study to Assess the Safety and Efficacy of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid

For information about this trial, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org. See full clinical trial information.

Principal investigator: Carmen M. Stanca, MD

Nonalcoholic Steatohepatitis

Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Participants with Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (ATLAS)

For information about this trial, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org. See full clinical trial information.

Principal investigator: Ira M. Jacobson, MD

Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment (REGENERATE)

For information about participating in this trial, including eligibility criteria, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org. See full clinical trial information.

Principal investigator: James S. Park, MD

AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults with NASH

For information about participating in this trial, including eligibility criteria, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org. See full clinical trial information.

Principal investigator: James S. Park, MD

Nonalcoholic Steatohepatitis with Cirrhosis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Nonalcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension

For information about participating in this trial, including eligibility criteria, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org.

Principal investigator: Viviana Figueroa Diaz, MD

Safety and Efficacy of Selonsertib in Adults with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (STELLAR 4)

For information about this trial, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org. See full clinical trial information.

Principal investigator: Carmen M. Stanca, MD

Emricasan, a Caspase Inhibitor, for Treatment of Subjects with Decompensated NASH Cirrhosis (ENCORE-LF)

For information about participating in this trial, including eligibility criteria, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org. See full clinical trial information.

Principal investigator: Viviana Figueroa Diaz, MD

Randomized Phase III Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

For information about participating in this trial, including eligibility criteria, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org.

Principal investigator: James S. Park, MD

Nonalcoholic Steatohepatitis with Fibrosis

Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients with Nonalcoholic Steatohepatitis (NASH) (RESOLVE-IT)

For information about participating in this trial, including eligibility criteria, contact Mary Olson or Kristyn Pierce at 212-263-3643 or mary.olson@nyulangone.org. See full clinical trial information.

Principal investigator: Ira M. Jacobson, MD