Table 4.

Primary efficacy endpoints in clinical trials of advanced therapies for ulcerative colitis.

Clinical trial	Induction primary efficacy endpoint	Maintenance primary efficacy endpoint
ACT 1 and ACT 2 [induction and maintenance]	Clinical response [Week 8]	No primary endpoint for maintenance phase
ULTRA 1 [induction], ULTRA 2 [induction and maintenance]	Clinical remission [Week 8], Clinical remission [Week 8; co-primary with Week 52 endpoint]	N/A, Clinical remission [Week 52; co-primary with Week 8 endpoint]
PURSUIT-SC [induction], PURSUIT-M [maintenance]	Clinical response [Week 6], N/A	N/A, Clinical response [Week 54]
GEMINI 1 [induction], GEMINI 1 [maintenance]	Clinical response [Week 6], N/A	N/A, Clinical remission [Week 52]
OCTAVE Induction 1 and Induction 2 [induction], OCTAVE Sustain [maintenance]	Remissiona [Week 8], N/A	N/A, Remissiona [Week 52]
TOUCHSTONE [induction and maintenance]	Clinical remission [Week 8]	No primary endpoint for maintenance phase
HICKORY [induction and maintenance]	Remissiona [Week 14; co-primary]	Remissiona [Week 66; among randomised patients in clinical remission at Week 14; co-primary]

^aThe OCTAVE and HICKORY trials used a more stringent definition of remission as the primary endpoint—equivalent to the definition of clinical remission used in the other trials with the additional requirement of a rectal bleeding subscore = 0.

N/A, not available.