NCT03345849.

Trial name or title	A multicenter, randomized, double‐blind, placebo‐controlled induction study of the efficacy and safety of upadacitinib (ABT‐494) in subjects with moderately to severely active Crohn's disease who have inadequately responded to or are intolerant to conventional therapies but have not failed biologic therapy
Methods	A multicentre, randomised, double‐blind, placebo‐controlled induction study
Participants	300 adults (aged 18 ‐ 75 years) with a confirmed diagnosis of Crohn's disease for at least 3 months prior to baseline, moderate‐to‐severe disease activity with evidence of mucosal inflammation and previous inadequate response or intolerance to conventional therapies
Interventions	Experimental: upadacitinib dose A (oral; once daily) for 12 weeks Comparator: matching placebo for upadacitinib
Outcomes	Primary outcomes: Endoscopic response (SES‐CD at week 12) Clinical remission (average daily stool frequency and average daily abdominal pain score at week 12) Secondary outcomes: Crohn's Symptoms Severity Questionnaire (CSS at week 12) Enhanced Clinical Response (decrease in average daily SF and/or decrease in average daily AP score at week 2) Discontinuation of corticosteroid use for CD (at week 12) Clinical remission (average daily stool frequency and average daily abdominal pain (AP) score at week 12) Fatigue (FACIT‐F at week 12) Quality of life (SF‐36 at week 12) Endoscopic remission (SES‐CD at week 12) Reduction in draining fistulas (>= 50% at week 12) Clinical remission (CDAI < 150 at week 12). Hospitalisations due to CD (at week 12)
Starting date	December 2017
Contact information	AbbVie Call centre Telephone: 847.283.8955 Email: abbvieclinicaltrials@abbvie.com
Notes	Estimated study completion date: March 2020 Estimated enrollment: 300 participants