ACTIVE STUDIES
BARRETT’S ESOPHAGUS
Lucid Diagnostics, Inc.
A Multicenter, Single-Arm Study of the Efficacy of EsoGuard™ on Samples Collected Using EsoCheck™ versus Esophagogastroduodenoscopy for the Diagnosis of Barrett’s Esophagus in an At-Risk Screening Population.
CLOSTRIDIUM DIFFICILE (RECURRENT)
Finch Research and Development LLC
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4).
CROHN’S DISEASE
Abbvie M20-259
A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy.*
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.*
CRC SCREENING STUDY
Exact Sciences BLUE-C 2019-01
Clinical Validation of an Optimized Muiti-Target Stool DNA (mt-sDNA 2.0) Test, For Colorectal Cancer Screening “BLUE-C”.
Exact Sciences 2019-01B
Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: “Clinical Validation of an Optimized Multi-Target Stool DNA (mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C”.
LIVER CANCER SCREENING
Helio Health (HELIO) (CLiMB)
Prospective Clinical Trial to Detect Liver Cancer through Quantification of cfDNA Methylation in Blood Samples in patients at high risk for Hepatocellular Carcinoma undergoing routine screening.
SHORT BOWEL SYNDROME
VectivBio Stars TA799-007
A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF).
ULCERATIVE COLITIS
Abbvie M16-067
A multicenter, randomized, double-blind, placebo controlled induction study of the efficacy and safety of Risankizumab in subjects with moderately to severly active Ulcerative Colitis who have failed prior biologic therapy .*
Arena Gladiator APD334-210
A Randomized, Double-Blind, Placebo-Controlled, 52 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis.*
LEFT SIDED UC
Index CS UC 01-21
A Phase 3 study to evaluate the efficacy and safety of Cobitolimod (PR) as an induction and maintenance therapy in participants with moderate to severe left sided UC.
*There are long term open label extensions for Abbvie and Arena studies.
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.
OPENING SOON…
CROHN’S DISEASE
Abbvie M20-371
A Randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of ABBV-154 in subjects with moderately to severely active Crohn’s disease
AstraZeneca D5271C00001
A 52-week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallellgroup Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID Lead-In).
Janssen FUZION CD 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.
ULCERATIVE COLITIS
AstraZeneca D5272C00001 / CSP v5.0 Title
A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active -Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis.
AstraZeneca D5272C00001 / CSP v6.0 Title
A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis.
TLL Pharmaceutical TLL018-202
A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, study to evaluate the safety and efficacy of TLL018 for induction therapy in subjects with moderate to severe ulcerative colitis.
PBC
Intercept
A Phase 2a, double-blind, randomized, active controlled, parallel group study evaluating the efficacy, safety and tolerability of bezafibrate administered in combination with obeticholic acid in subjects with PBC.