A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Crohn’s Disease

Research summary

This protocol includes 2 independent, multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (Study 1 and Study 2) to assess the efficacy and safety of MK 7240 in participants of any sex/gender aged 16 to 75 (inclusive) with moderately to severely active CD. While this “master” protocol includes common operational elements for both Study 1 and Study 2, randomization, data collection, statistical analyses, and data reporting will be conducted for each study independently. Each study has its own objectives and type 1 error-controlled hypotheses with adequate power for all primary and key secondary endpoints. Study 1 is a Phase 3, 52-week induction and maintenance treat-through study to evaluate the efficacy and safety of MK-7240 compared to placebo in inducing clinical remission (per CDAI score) and endoscopic response at Week 12 in participants with moderate to severe active CD, followed by a treat-through maintenance period of 40 weeks to evaluate efficacy and safety of MK-7240 compared to placebo in achieving clinical remission (per CDAI score) and endoscopic response at Week 52. Study 1 consists of a screening period (up to 5 weeks), a placebo-controlled double-blind Treatment Period (52 weeks), and a safety follow-up period for approximately 12 weeks after the last dose of study intervention. Additional treatment periods include an open-label Reinduction Period (12 weeks) for participants who meet escape criteria during maintenance or non-responder criteria at Week 52, and a double-blind Extension Period (up to 3 years or relevant country/region drug market authorization or access) for participants who are responders at Week 52 of the placebo-controlled double-blind portion of the study or at Week 12 of the open-label Reinduction Period. The duration of the double-blind Treatment Period of Study 1 will be approximately 1.3 years (with up to approximately 16 clinic visits) with an extension of participation for up to 4.3 years total for each participant. Study 2 is a replicate Phase 3, 12-week induction study to evaluate the efficacy and safety of MK-7240 compared to placebo in inducing clinical remission (per CDAI score) and endoscopic response at Week 12 in participants with moderate to severe active CD. Study 2 enrollment may be initiated when Study 1 has reached target enrollment of advanced therapy-experienced participants (65%) or is fully enrolled. Study 2 consists of a screening period (up to 5 weeks), a placebo-controlled double-blind Treatment Period (12 weeks), and a safety follow-up period for approximately 12 weeks after the last dose of study intervention. Additional treatment periods include an open-label Reinduction Period (12 weeks) for participants who meet non-responder criteria at Week 12, and a double-blind Extension Period (up to 3 years or relevant country/region drug market authorization or access) for participants who are responders at Week 12 of the placebo-controlled double-blind Treatment Period or at Week 12 of the open-label Reinduction Period. The duration of the placebo-controlled double-blind Treatment Period of Study 2 will be approximate 0.6 years (with up to approximately 9 clinic visits) with an extension of participation for up to 3.6 years total for each participant.

Principal Investigator

Dr Oliver Brain

Contact us

Email: ctf.research@ouh.nhs.uk

IRAS number

1009747