Yoshimura 2015.

Methods	Randomised, double‐blind, placebo‐controlled, phase IIa study (N = 102)
Participants	Patients were 20‐65 years of age with a diagnosis of moderately active UC (MCS 6‐10, a rectal bleeding subscore of 1 or higher, and an endoscopic subscore of 2 or higher) Patients had inadequately responded or had an intolerance to 5‐ASA and/or corticosteroids
Interventions	Group 1: 960 mg AJM 300 (n = 51) Group 2: placebo (n = 51) Patients received treatment 3 times daily for 8 weeks
Outcomes	Primary outcome: clinical response (decrease in MCS > 3 points and a decrease of > 30% from the baseline score, with a decrease > 1 point on the rectal bleeding subscore or an absolute rectal bleeding subscore of 0 or 1) Secondary outcomes: clinical remission (MCS of < 2 and no subscore > 1), mucosal healing (endoscopic subscore of 0 or 1), PMCS and adverse events
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Dynamic balancing allocation with minimization method
Allocation concealment (selection bias)	Low risk	Randomisation performed centrally
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Patients, assessing physicians, and the funder were blinded to the assignment of treatment throughout the study
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Patients, assessing physicians, and the funder were blinded to the assignment of treatment throughout the study
Incomplete outcome data (attrition bias) All outcomes	Low risk	10 patients discontinued from the placebo group; 4 patients discontinued from the AMJ 300 group
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported
Other bias	Low risk	The study appears to be free of other sources of bias

UC: ulcerative colitis

ASA: aminosalicylic acid

SC: subcutaneous

TNF‐α: Tumour necrosis factor‐alpha

AZA: azathioprine

6‐MP: 6‐mercaptopurine

CRP: C‐reactive protein

DAI: Disease Activity Index

UCDAI: Ulcerative Colitis Disease Activity Index

CAI: Clinical Activity Index

ITT: intention‐to‐treat

LDP‐02: vedolizumab ‐ a humanised a4b7 antibody

MCS: Mayo Clinic Score

MLN02: vedolizumab ‐ a humanised a4b7 antibody

IV: intraveneous

IBDQ: Inflammatory Bowel Disease Questionnaire

UCCS: Ulcerative Colitis Clinical Score

PGA: physician's global assessment

MMX: Multi Matrix System

BMS‐936557: anti‐IP‐10 antibody

IFN‐βb‐1a: interferon beta‐1a

ACT‐1: Active Ulcerative Colitis Trial 1

ACT‐2: Active Ulcerative Colitis Trial 2

PMCS: Partial Mayo Clinic Score

MMDAI: Modified Mayo Disease Activity Index

SASP: sulfasalazine

AJM 300: an oral alpha4 integrin antagonist