Clinical Research Studies

This study is a randomized, double-blind, placebo-controlled, multicenter, Phase 2b study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 (as capsule, P.O.) versus placebo in study participants with moderately to severely active UC. The study will have 4 treatment groups: (1) MORF-057 (xxx mg B.I.D., P.O.), (2) MORF-057 (xxx mg B.I.D., P.O.), (3) MORF-057 (xxx mg Q.D., P.O.), and (4) matching placebo (B.I.D, P.O.). Approximately 280 participants will be randomized into the treatment groups in a 1:1:1:1 ratio (i.e, 70 participants per group). For each treatment group, at least 40% of the participants will be advanced therapy-naïve (i.e., have no previous exposure to an advanced therapy treatment for UC) and at least 40% will be advanced therapy-experienced (excluding vedolizumab). Randomization stratification factors will include baseline MES (<3 vs 3) and previous use of advanced therapy treatment (advanced therapy-naïve vs advanced therapy-experienced). All participants will be enrolled from approximately 130 centers located in North America and Europe. For this study, moderately to severely active UC will be defined as having a mMCS of 5 to 9 (inclusive), with an MES =2 (confirmed by central reader) and a rectal bleeding subscore =1. An independent Data and Safety Monitoring Board (DSMB) will review participant safety data throughout the study. Details related to the DSMB will be clearly delineated in the DSMB Charter. This Phase 2b study will consist of 3 study periods: a Screening Period (up to 4 weeks, consisting of Stage 1 and Stage 2 testing), a Treatment Period (52 weeks, including a 12-week Induction Period and a 40-week Maintenance Period), and a Safety Follow-up Period (4 weeks). During the study, there will be approximately 11 scheduled study visits: Screening Visit(s) (Visit 1 at Weeks -4 to -1), multiple Treatment Visits (Visits 2-10 at Weeks 0, 2, 6, 12, 18, 24, 36, 42, and 52 [End of Treatment]), and a Safety Follow-up (SFU) Visit (visit to occur 4 weeks after the last dose of study drug is received, which will be Visit 11 at Week 56 if the full study is completed or earlier if treatment is discontinued early). Study Day 1 represents the first day of the Treatment Period (i.e., when the participant will receive the first dose of study drug). Participants in the active MORF-057 treatment groups will continue the same dose regimen (according to group assignment) for the full 52-week Treatment Period. Participants initially randomized into the placebo group will be switched to an active MORF-057 regimen after they complete the Induction Period and the Week 12 assessments. Any patient who has not shown clinical improvement (as determined by the Investigator) by Week 24 may be discontinued from the study following an End of Treatment (EOT) Visit and a SFU Visit. Participants who complete the 52-week Treatment Period and associated assessments may be eligible to enroll in a separate Open-label Extension study. Participants who are eligible and willing to enroll into the Open-label Extension study will not complete the SFU Period for the current study; instead, they will directly enter the Open-label Extension study. Participants who do not enroll into the separate Open-label Extension study must complete the final SFU Period for the current study, including the Week 56 Visit (4 weeks after receiving the last dose of MORF-057), for a maximum time on-study of 62 weeks.