NCT04173273.

Study name	A study evaluating the efficacy and safety of etrasimod in the treatment of patients with moderately to severely active Crohn's disease (CULTIVATE)
Methods	RCT, multicentre
Participants	225 adults 18 to 80 years old
Interventions	IGa: etrasimod dose A taken by mouth, once daily IGb: etrasimod dose B taken by mouth, once daily CG: matching placebo taken by mouth, once daily
Outcomes	Primary outcome measures: Proportion of participants who achieve endoscopic response [ Time Frame: Week 14 ] Endoscopic response is defined as ≥ 50% decrease from baseline in simple endoscopic score in Crohn's disease (SES‐CD). Secondary outcome measures: Proportion of participants who achieve clinical remission worst daily Abdominal Pain With Loose/Watery Stool Frequency (APSF) scores [ Time Frame: Week 14 ] Clinical remission APSF is defined as unweighted average worst daily abdominal pain (AP) score ≤ 1 (using a 4‐point scale, i.e. 0 (none) to 3 (severe)) and unweighted average daily loose/watery (Bristol Stool Form Scale (BSFS) type 6 or 7) SF score ≤ 3. Number and severity of adverse events [ Time Frame: Up to Week 66 ]
Starting date	12 February 2020
Contact information	ct.gov@arenapharm.com
Notes	Sponsor: Arena Pharmaceuticals

CG: control group

CRP: C‐reactive protein

ESR: erythrocyte sedimentation rate

fMRI: functional magnetic resonance imaging

HBI: Harvey‐Bradshaw Index

IBD: inflammatory bowel disease

IBS‐SSS: Irritable Bowel Syndrome ‐ Severity Scoring System

IG: intervention group

MRI: magnetic resonance imaging

RCT: randomised controlled trial

SCCAI: Simple Clinical Colitis Activity Index

SD: standard deviation

VAS: visual analogue scale