Table 2.

Ongoing observational studies on Ozanimod in ulcerative colitis (UC)

NCT number	Study acronym	Type of study	Aim	Study population	Primary outcome measures	Sponsor	Study status
NCT06126835	NA	A Retrospective Observational Cohort Study	To Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With UC and Their Infants	Pregnant Women With UC and Their Offspring (18–49 Years)	Prevalence of major congenital malformations among infants born to pregnant women with UC who were exposed to ozanimod during the first trimester relative to the prevalence among (i) infants born to women with UC exposed to conventional UC treatments and (ii) infants born to women with UC exposed to advanced UC treatment during first trimester of pregnancy. Up to 10 years	Bristol-Myers Squibb	NOT YET RECRUITING Completion Date (estimated) 2031-05-31
NCT05953402	NA	A Prospective, Observational Study (Patient Registry)	To evaluate the Safety of Ozanimod Exposure in Pregnant Women With UC and Their Offspring	Pregnant Women With UC and Their Offspring (Child, Adult, Older Adult)	Event rate of Major Congenital Malformations Up to 12 months	Bristol-Myers Squibb	NOT YET RECRUITING Completion Date (estimated) 2032-06-30
NCT05382715	COLIBRI	A Four Year, Multicenter, Prospective, Observational Study in Clinical Routine	A Study to Evaluate the Utilization, Effectiveness of Ozanimod, and Quality of Life	Ozanimod-treated Participants With moderate-to-severe UC (18 Years and older)	Number of participants with Clinical Remission, defined by a partial MS of 1 plus an RBS = 0 At weeks 10, 52, and one year	Bristol-Myers Squibb	RECRUITING Completion Date (estimated) 2026-11-30

MS Mayo score, TEAEs Treatment-emergent adverse events, AEs Adverse events, SAEs Serious adverse events