Table 1.

Primary and secondary endpoints of MARVEL

Primary endpoint	Secondary endpoints
Clinical response at week 12	Clinical remission at week 12 = complete Mayo score of ≤2 points and no individual subscore >1 point
Defined by a decrease from baseline of Mayo score of at least 3 points and at least 30%;
With accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of rectal bleeding of 0 or 1
	Clinical response and remission based on partial Mayo score at week 24 (Mayo score of 2 or less + no subscore >1 point
	Mucosal healing – endoscopic Mayo score of 0 or 1 at week 12
	Normalisation of faecal calprotectin (<250 μg/ml) at week 12 and 24 compared to baseline
	Normalisation of faecal haemoglobin (10 μg/g faeces) at week 12 and 24 compared to baseline
	Quality of life at 12 and 24 weeks
	Side effects/adverse outcomes
	Drug concentration analyses and research into biomarkers and pharmacogenetics at 0, 12, and 24 weeks
	Proportions of primary treatment failure within 24 weeks study period requiring escalation in medical treatment as below:
	• Re-treatment with oral or intravenous corticosteroids
	• Biologics (anti-TNF, anti-α4β7, anti-IL23 and oral Jak-inhibitors)
	• Azathioprine or 6-mercaptopurine in participants who are currently not on a thiopurines
	• Oral or intravenous ciclosporin