Gastroenterology and Hepatology Clinical Trials

Penn State Health features the only comprehensive celiac center in central Pennsylvania. In addition to this specialty clinic, researchers are also studying treatments for celiac disease through clinical trials.

A Phase 1b Open-Label/ Phase 2 Double-Blind Placebo controlled Study For Pharmacodynamic Activity, Pharmacokinetics, Safety And Tolerability Of KAN-101 In Patients With Celiac Disease

Short title: A Study Of Safety, Tolerability, Pharmacodynamics, And Pharmacokinetics Of KAN-101 In Celiac Disease (ACeD-it)
NCT number: NCT05574010
Sponsor: Anokion SA (Kanyos Bio, Inc.)
Primary investigator: Kofi Clarke, MD

These trials encompass a wide variety of common topics related to digestive disease. Presently, our investigators are participating in trials evaluating new methods for monitoring and managing colon cancer and using fecal microbial therapy for the treatment of recurrent Clostridium difficile diarrhea and other disorders.

Studies will be posted here when they become available.

Hepatology focuses on studying potential therapies for the management of liver-related diseases and disorders. Researchers are involved in a variety of single and multi-center trials designed to examine potential treatments for alcoholic hepatitis, non-alcoholic steatohepatitis and liver-associated cancers.

Learn more on the liver research website

These trials are focused on investigating potential therapies for Crohn’s disease (CD), ulcerative colitis (UC), microscopic colitis and their associated complications. Researchers are involved in several multi-center pharmaceutical trials evaluating new medications for CD and UC.

If you are interested in participating in an IBD clinical trial, please fill out this survey.

IBD clinical trials survey

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

Short title: A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn’s Disease (CULTIVATE)
NCT number: NCT04173273
Sponsor: Arena Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc.
Primary investigator: Kofi Clarke, MD

Other trials in preparation

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

Short title: ABTECT-2 – ABX464 Treatment Evaluation for ulcerative Colitis Therapy -2
NCT number: NCT05507216
Sponsor: ABIVAX S.A.
Primary investigator: Kofi Clarke, MD

A randomized, double-blind, multicenter phase III study to evaluate the long-term efficacy and safety of ABX464 25 mg or 50 mg once daily as a maintenance therapy in subjects with moderately to severely active ulcerative colitis

NCT number: NCT04023396
Sponsor: ABIVAX S.A.
Primary investigator: Kofi Clarke, MD

This specialty focuses on the management of functional and neuromuscular disorders of the digestive system, including:

• Irritable bowel syndrome, also known as IBS
• Dysphagia, also known as difficulty swallowing, gastroparesis
• Chronic constipation and fecal dyssynergia, also known as difficulty passing bowel movements)

Researchers are actively studying the use of domperidone for gastroparesis as well as a novel therapy for eosinophilic esophagitis.

Domperidone Protocol: Use of Domperidone to Treat Patients with Gastrointestinal Disorders who have Failed Standard Therapy.

Primary investigator: Meeta Desai, MD

The purpose of this study is to treat patients who are facing a serious condition (gastroparesis) that lacks therapeutic alternatives.

This is not a traditional clinical trial, as the intention of this study is not to obtain information about the safety or effectiveness of the drug. Rather, the study allows access to otherwise unavailable drug domperidone under the FDA’s Compassionate Use Program.

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 Subjects with Eosinophilic Esophagitis.

Sponsor: Celgene
Primary investigator: Kofi Clarke, MD

The scope of the study is to use a novel biologic drug, CC-93538, against symptoms of esophageal dysfunction, including inflammation in people with Eosinophilic esophagitis (EoE). The CC-93538 will target the IL-13 receptor, a key driver of disease pathology in EoE. In addition, the study will evaluate the safety and efficacy of CC-93538 in placebo-controlled Induction, Maintenance and Open-Label Extension study programs.

A Phase 3, Multicenter, Multinational, Open-Label Extension Study To Evaluate The Long-Term Safety Of Cc-93538 In Adult And Adolescent Subjects With Eosinophilic Esophagitis

Short title: Safety study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
NCT number: NCT04991935
Sponsor: Celgene
Primary investigator: Kofi Clarke, MD

Other trials in preparation

Diagnosis: Eosinophilic esophagitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults With Active Eosinophilic Esophagitis (The “EvolvE” Study)

Short Title: A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
NCT number: NCT05774184
Sponsor: Celldex Therapeutics
Primary investigator: Kofi Clarke, MD

This sub-specialty focus on evaluation of diseases and disorders of the pancreas and biliary tree as well as use of advanced endoscopic techniques in the management of digestive disorders. Currently active trials include studies of novel methods for colonic polyp removal and preventing post-polypectomy bleeding, as well as new techniques for managing pancreatic cysts.

CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: A Prospective, Randomized, Double-blind, Multi-center Clinical Trial.

Learn more on Studyfinder