CLOSTRIDIODES DIFFICILE INFECTION

Vedanta VE303-003 THE RESTORATIVE303 STUDY

Randomized, double-blind, placebo-controlled phase 3 study of VE303 for prevention of recurrent Clostridioides difficile infection

CROHN’S DISEASE

Abbvie M23-784

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects with Moderately to Severely Active Crohn’s Disease

Arena Cultivate APD334-202

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 TA-279-CD-2001

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of TA-279, A TYK2 Inhibitor, of Once Daily dosing in the Treatment of Patients with Moderately to Severely Active Crohn’s Disease.

FISTULIZING CROHN’S DISEASE

Janssen Fuzion CNTO1959CRD3005

A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn’s Disease.

FAMILIAL ADENOMATOUS POLYPOSIS (FAP)

Recursion REC-4881-201

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of REC-4881 in Patients with Familial Adenomatous Polyposis (FAP).

IgG4-RELATED DISEASE

Pharmaceutical Supported

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients with IgG4-Related Disease (INDIGO).

NASH

Akero Synchrony Histology A-US-001-0105

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH) and Fibrosis.

Akero Synchrony Real World A-US-001-0107

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

ALT-801-203

A Phase 2, Multicenter, Randomized, Double-blind, Placebo controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects with Nonalcoholic Steatohepatitis (NASH)

Zydus SARO.20.002

A Phase 2b, Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis

ULCERATIVE COLITIS

BMS IM047029

A Phase 4, Prospective, Open label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants with Moderate to Severe Ulcerative Colitis in Clinical Practice

Gilead GS-US-457-6411

A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis

Takeda TA-279-UC-2001

A Phase 2b Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Oral TA-279 in Subjects with Moderately to Severely Active Ulcerative Colitis.

Vedanta

VE202-002 Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis

ULCERATIVE PROCTITIS

Cristcot CHS1221

A Three-Arm, Randomized, Placebo-Controlled, Double Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum.

Study medications, labs and other procedures are provided free of charge to patients and travel will be compensated.

Contact the research office at (239) 649-1336 with any questions.

Abbvie M23-703

A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Akero Synchrony Outcomes AK-US-001-0106

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH).

Lumen CDI02 (RePreve)

A randomized, double-blind, placebo-controlled study of LMN-201 for prevention of C. difficile infection recurrence

Takeda VICTRIVA -3043

A Randomized, Double-Blind, Placebo-Controlled Phase 3b Study to Evaluate the Short- and Long-Term Efficacy and Safety of Dual Targeted Therapy With an Intravenous monoclonal antibody medication and Oral Upadacitinib Compared with With Intravenous monoclonal antibody medication for the Treatment of Adult Participants With Moderately to Severely Active Crohn’s Disease.