NCT02974322.

Methods	Study design: RCT Setting: NS
Participants	0
Interventions	IG: GED‐0301 1 x 160 mg tablet once daily and GED‐0301 4 x 40 mg tablets once daily CG: placebo once daily
Outcomes	Starting date: 1 December 2017 Estimated completion date: abandoned Outcomes: Primary Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (USA) and CDAI (rest of world) [ Time Frame: Week 12 ] The proportion of participants achieving clinical remission at Week 12. Secondary Clinical remission defined by an average daily liquid or soft stool frequency and abdominal pain score (USA) and CDAI [ Time Frame: Week 4, Week 12 ] The proportion of participants achieving clinical remission at Week 4, Week 12. Endoscopic improvement by the Simple Endoscopic Score for Crohn's Disease (SES‐CD) [ Time Frame: Week 12 ] Endoscopic improvement of the mucosa at Week 12. Clinical response defined by CDAI [ Time Frame: Week 4, Week 12 ] The proportion of participants achieving clinical response at Week 4, Week 12. Clinical remission defined by PCDAI [ Time Frame: Week 12 ] The proportion of participants achieving clinical remission at Week 12 (adolescent participants only). Adverse events [ Time Frame: up to 20 weeks ] Incidence and severity of adverse events. Pharmacokinetics ‐ plasma concentration of GED‐0301 [ Time Frame: Week 4, Week 8 ] The plasma concentration of GED‐0301 at Week 4, Week 8.
Notes	Funding: Celgene Contact: support@vivli.org This study was never begun. No patients were enrolled (or even screened), so there are no results to share.