Mitchell K. Spinnell, MD

Research

• 2021 – A phase 3 multicenter, long term extension study of Mirikizumab in patients with Crohn’s Disease, I6T-MC-AMAX; Sponsor: Eli Lilly and Company
• 2020 – current; Investigator; A Phase III, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1); Sponsor: Eli Lilly and Company
• 2018 – Investigator; A Phase III Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Rebiotix RBX2660 (microbiota suspension) for the Prevention of Recurrent Clostridium difficile Infection; Sponsor: Rebiotix Inc.
• 2018 – Principle Investigator; A Phase II, Multicenter, Randomized, Parallel-Arm, Placebo-controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY); Sponsor: Eli Lilly and Company
• 2014 – 2018; A Phase III Randomized, Double Blind, Placebo-Controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of a Fixed-Dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease; Sponsor: RedHill Biopharma Limited
• 2012 – 2015; Principle Investigator; A Randomized, Double-Blinded, Active-Controlled Study of CB_183,315 in Patients with Clostridium Difficile Associated Diarrhea; Sponsor: Cubist Pharmaceuticals LLC
• 2013 – 2014; Principle Investigator; A Phase II Study to Evaluate the Efficacy and Safety of 12 Weeks of Treatment With Oral CNDO 201 Trichuris Suis Ova Suspension (TSO) as Compared to Placebo, Followed by a 12 Week Open-label Treatment Period in Patients With Moderately to Severely Active Crohn’s Disease; Sponsor: Coronado Biosciences
• 2006 – 2012; Investigator; Limited Access Protocol for the Use of Oral Cisapride in the Treatment of Refractory Gastroesophageal Reflux Disease and other Gastrointestinal Motility Disorders. Sponsor: PRA International, for Janssen Pharmaceuticals
• 2009 – 2011; Principle Investigator; A Phase II Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study to Assess the Immunogenicity and Safety of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF) in Subjects with Clostridium Difficile Injection (CDI); Sponsor: Sanofi Pasteur
• 2008 – 2010; Principle Investigator; A Randomized Double-Blind Parallel Study of Rabeprazole extended release versus Esomeprazole after 4 to 8 weeks of treatment among subjects with erosive GERD; Sponsor: Eisai Pharmaceuticals
• 2008 – 2010; Principle Investigator; A Phase III, multicenter, placebo-controlled, randomized, double-blind study to evaluate the safety and efficacy of PROCHYMAL (ex vivo cultured adult human mesenchymal stem cells) intravenous infusion for the induction of remission in subjects experiencing treatment-refractory moderate-to-severe Crohn’s disease; Sponsor: Osiris Therapeutics
• 2007 – 2008; Principle Investigator; A Double-Blind, Randomized, Placebo-Controlled multicenter study to assess the safety and efficacy of AST-120 in mild to moderately active Crohn’s patients with fistulas. Sponsor: Ocera Therapeutics
• 2006 – 2009; Principle Investigator; A Double-Blind, Randomized, Controlled Trial of Rifaxamin Compared to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea. Sponsor: Salix Pharmaceuticals