Enrolling Research Studies 15 November 2017
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1 Enrolling Research Studies 15 November 2017 Crohn s Disease/ Ulcerative Colitis Humira (AbbVie) Crohn s Disease (Eli Lilly) Ulcerative Colitis (Genentech) Crohn s Disease (Genentech) Crohn s Disease / Ulcerative Colitis (Gilead) Crohn s Disease (Takeda) Ulcerative Colitis (Pfizer) Ulcerative Colitis (Receptos) Ulcerative Colitis (Abbvie) Fistualizing Perianal Crohn s Disease (Gilead) Small Bowel Crohn s Disease (Gilead) Iron Deficiency Anemia (Shield) Crohn s Disease (Abbvie) NASH (Intercept) NASH Cirrhosis (Intercept) NASH Cirrhosis (Connatus) NAFLD (Gilead) NASH and NASH/Cirrhosis (Gilead) NASH (Proof of Concept no placebo) (Gilead) NASH (Allergan) NASH (Cirius) Gastroparesis (Allergan) Eosinophilic Esophagitis (SHIRE) Coming soon: Abbvie Crohn s Oral ABT 494 Bio exp./naïve Allergan Gastroparesis
2 ABBVIE Crohn s and UC Looking for patients who would be a good Humira candidate (either anti- TNF naïve or secondary failure/intolerance to Remicade) No need to have on Imuran. No PLACEBO. Randomized to standard induction vs higher induction dose. Call 2133
3 ELI LILLY Crohn s Disease Induction and maintenance in subjects that are biologic naïve or failures. SubQ IL-23 antagonist Call 2107
4 GENENTECH UC TNF Naïve Very promising alpha 4-beta 7 and alpha E-beta 7 integrin. Call 2114
5 GENENTECH UC Anti TNF Failures. Very promising alpha 4-beta 7 and alpha E-beta 7 integrin. Call 2114
6 GENENTECH Crohn s Disease Evaluate safety and efficacy of Etrolizumab as an induction and maintenance treatment for patients with Mod to Severely active Crohn s Disease Call 2114
7 GILEAD Crohn s and UC Moderately to Severely Active Crohn s Disease / Ulcerative Colitis Filgotinib (JAK inhibitor) Call 2141
8 TAKEDA Crohn s Disease Mod to Severe active Crohn s disease. Must have failed tx with steroids immunosuppressants and/or anti-tnf Vedolizumab IV induction then SQ Call 2134
9 PFIZER Ulcerative Colitis Moderate to severe UC Placebo Controlled Induction and chronic therapy using PF and PF Call 2116
10 RECEPTOS Ulcerative Colitis Trial of Oral RPC 1063 as therapy for Moderate to Severe Ulcerative Colitis Call 2134
11 ABBVIE Ulcerative Colitis ABT-494 Induction and maintenance therapy in patient with mod to severely active UC. Must have failed corticosteroids, immunosuppressants and/or biologics Call 2107
12 GILEAD Perianal Fistualizing Crohn s Disease 1-3 draining perianal fistula with external openings of > 4 weeks Evaluating the safety and efficacy of Filgotinib (placebo controlled) Call 2134
13 GILEAD Small Bowel Crohn s Disease Placebo Controlled-MRI based. No colonoscopy required. Efficacy and safety study of Filgotinib Call 2134
14 SHIELD Iron Deficiency Anemia IDA in IBD patients only Randomized controlled study with oral ferric maltol or IV iron ferric carboxy maltose IV iron vs. novel oral formulation with better absorption/tolerability. Call 2141
15 GILEAD UC Double blind study for Males Monitor testicular safety of subjects on filgotinib with moderate to severe UC (ages 25-55) CALL 2116
16 GILEAD Crohn s Disease Induction study to assess the efficacy and safety of Risankizumab in subjects with Moderately to severely active Crohn s disease. 2 separate studies- 1 for Biologic failure and 1 for inadequate response CALL 2107
17 SHIRE Ulcerative Colitis Placebo controlled study with SHP647 (anti- MADCAM) in moderate to severe UC. Allows mesalamine failures only. Call 2141
18 INTERCEPT NASH Long term study, placebo controlled, evaluating the safety and efficacy of Obeticholic acid in subjects with NASH. Call 2134
19 INTERCEPT NASH Cirrhosis Placebo controlled use of Obeticholic acid in subjects with NASH compensated cirrhosis. Allows patients with burnt-out NASH. Call 2134
20 CONNATUS NASH Cirrhosis Emricasan in patients with NASH Cirrhosis and +HPVG >/= 12 Either compensated (portal hypertension) or 1 decompensation (i.e variceal bleed, ascites OR encephalopathy) Call 2114
21 GILEAD NASH Efficacy of Selonsertib in patients with F3 Nash Liver biopsy if none < 6 months Call 2116
22 GILEAD NASH/Cirrhosis Efficacy of Selonsertib in patients with compensated cirrhosis Liver biopsy if none < 1 year Call 2116
23 GILEAD NASH Proof of Concept No Placebo No Liver Biopsy Required Only MRI/MRE Call 2107
24 ALLERGAN NASH Cenicriviroc for subjects with NASH. F2-F3 only. Requires liver biopsy at screening (if not done in the previous 180 days and repeat biopsy after treatment) CALL 2141
25 CIRIUS Emminence NASH 12 month, multi dose study to evaluate safety, tolerability and efficacy of 3 dose levels of MSDC- 0602K in subjects with NASH CALL 2141
26 SHIRE Eosinophilic Esophagitis Double Blind placebo controlled study to evaluate Oral Budesonide suspension in adults with EOE. CALL 2107
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