The research division of Gastroenterology Group of Naples, under the direction of Dr. Raymond Phillips, is pleased to be offering the following clinical studies:
N103-001 A Phase 2, randomized, double-blind, parallel group dose-ranging study to evaluate the safety and efficacy of N1-03 compared to placebo in subjects with chronic pancreatitis.
CLOSTRIDIUM DIFFICILE (RECURRENT)
This Current Study Enrollment Period is Closed. A Multicenter, double-blind, parallel-arm, placebo-controlled phase 2 study of the efficacy, safety, and tolerability of single dose PO full spectrum microbiota (CP101) in subjects with recurrence of Clostridium difficile infection.*
Ri-CoDiFy 1 and Ri-CoDiFy 2
Ri-CoDIFy 1 and Ri-CoDIFy 2 are global, Phase 3 clinical trials designed to test how well ridinilazole (a trial medicine) works in treating Clostridium difficile infection (CDI) compared to vancomycin (the current standard of care medicine). A positive Phase 3 outcome may allow for the trial medicine (ridinilazole) to be approved by regulatory authorities and make it available as a potential option for the treatment of first episode of CDI or to reduce recurrence of CDI. Trial subjects must commit to 15 weeks of treatment. Participants will be given regular health checks, medical questionnaires, laboratory assessments, and physical examinations by Dr. Raymond Phillips. For more information on or to take part in this study, go HERE.
Abbvie M15-991 and M16-006
A multicenter, randomized, double-blind, placebo controlled induction study of the efficacy and safety of Risankizumab in subjects with moderately to severly active Crohn’s Disease.*
Genentech Bergamot GA29144
A Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of etrolizumab as an induction and maintenance treatment for patients with moderately to severely active Crohn’s disease. *
Gilead Diversity GS-US-419-3895
Combined Phase3, double-blind, randomized, placebo-controlled studies evaluating the efficacy and safely of Filgotinib in the induction and maintenance of remission in subjects with moderately to severely active Crohn’s Disease. *
Janssen SEAVUE CNTO1275CRD3007
A phase 3B, multicenter, randomized, blinded, active controlled study to compare the efficacy and safety of ustekinumab to that of adalimumab in the treatment of biologic naïve subjects with moderately-to-severely active Crohn’s Disease.
A cohort dose-escalation study to evaluate the safety of Metrodora Therapeutics’ Bovine Lactoferrin (MTbLF) in patients with anemia in Crohn’s Disease.
Allergan Pledge RLM-MD-02
A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis.
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 .*
A Phase 2, randomized, parallel-group, double blind, double-dummy, placebo controlled, multicenter study to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with placebo and compared with vedolizumab in patients with moderate to severe Ulcerative Colitis.
Genentech Hibiscus GA28948
A Phase III, placebo Controlled, multicenter study of the efficacy and safety of Etrolizumab vs Humira during induction and maintenance in Ulcerative Colitis.
A randomized, double blind, placebo-controlled phase 2 study to evaluate the testicular safety of Filgotinib in adult males with moderate to severe ulcerative colitis.
Opening soon: SERES 201ECO-RESET
A phase 2B, randomized, double blind, placebo controlled, multiple dose, multicenter study to assess efficacy and safety of SER-287 in adults with active mild-to -moderate Ulcerative Colitis.
UC OR CROHN’S
Takeda PASS Study
Entyvio long-term safety study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn’s Disease.
*There are long term open label extensions for Finch, Abbvie risankizumab, Genetech, and Gilead studies*
Study medications, labs and other procedures are provided free of charge to patients and travel will be compensated.
Recurrent Clostridium difficile infection:
Dr. Raymond Phillips has been approved by the Institutional Review Board of Naples Community Hospital to perform Fecal Microbiota Transplantation (FMT) on a protocol basis to prevent recurrent Clostridium difficile infection for those patients with 2 or more recurrences. FMT is an experimental procedure which has shown great promise for treatment of recurrent Clostridia difficile colitis.
Contact the research office at 239-649-1336 with any questions.