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Past studies at Bankstown Crohn's and colitis clinic: COMPLETED 2015 – Genentech – ETRO CD Protocol 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 Moderate To Severely Active Crohn’s Disease 2015 – Genentech – ETRO CD Protocol GA29145: An Open–Label Extension and Safety Monitoring Study of Patients with Moderately to Severely Active Crohn’s Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA 29144 2016 – 2018 Celgene – GED-0301 Protocol GED-0301-002 : A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects with Active Crohn’s Disease 2016 – 2018 Celgene – GED-0301 Protocol GED-0301-004 : A Phase 3, Long-Term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects with Active Crohn’s Disease 2015 – 2018 RedHill BioPharma Ltd/ InSymbiosis Protocol No : RHB-104-01 A Phase III, Double-Blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease 2008-2015 CDP – UCB Celltech (PPD) Protocol Number C87088 A Phase IIIb, multinational, open-label label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab’ fragment of a humanised anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s Disease who have participated in study C87085 2009-2014 MLN0002 – Millenium (Quintiles) Protocol No C13008 A Phase 3, Multiple Dose, Open-label Study to Determine the Long-Term Safety & Efficacy of MLN0002 in Patients with Ulcerative Colitis & Crohn's Disease 2012- 2014 CCX114643 (GSK) - Vercirnon Protocol No CCX 114643: A Randomised, Double-blind, Active Treatment Study to Induce the Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease 2011- 2014 CCX114151 (GSK) - Vercirnon Protocol No CCX 114151 : A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease 2011- 2014 CCX114157 (GSK) - Vercirnon Protocol No CCX 114157 : A 52 week Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease 2011-2014 CCX114644 (GSK) - Vercirnon Protocol No CCX 114644 : An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease 2010-2013 POCER – University of Melbourne Protocol POCER Post-Operative Crohn's Disease Endoscopic Recurrence “POCER” study: Endoscopic Guided Therapeutic Intervention& Determination of Cause 2011-2012 Lead Site MLN0002 – Millenium (Quintiles) Protocol C13011: A Phase 3, Randomised, Placebo-controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission By Vedolizumab in Patients With Moderate to Severe Crohn's Disease 2009-2012 MLN0002 – Millenium (Quintiles) Protocol No C13007 A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Multiple Dose Study to Determine the Efficacy & Safety of MLN0002 for the Induction& Maintenance of Clinical Response & Remission in Patients with Active Crohn's Disease 2009-2011 Ustekinumab – Centocor Protocol C0743T26 A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects with Moderately to Severely Active Crohn's Disease Previously Treated with TNF Antagonist Therapy 2008-9 CDP – UCB Celltech (PPD) Protocol Number C87085 A Phase IIIb, multinational, randomized, double-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab’ fragment of a humanised anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s Disease

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Note that optimization of the cross-linking protocol may be required