Merck KGaA registers Elowen-LTE Phase 3 lupus study and mirdametinib drug interaction trial

Two studies tied to Merck KGaA affiliates were first posted this week, both listed as not yet recruiting.

• EMD Serono Research & Development Institute registered "Elowen-LTE," a Phase 3, single-arm, open-label extension study of oral enpatoran in cutaneous lupus erythematosus with or without systemic disease. The study is meant to evaluate long-term safety and efficacy of enpatoran in participants who completed the Elowen-1 and Elowen-2 studies, offering active treatment for up to 108 weeks.¹ Enrollment is estimated at 404 participants.¹
• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, registered a Phase 1 drug interaction study assessing how probenecid affects the pharmacokinetics of mirdametinib and its metabolites in healthy participants. The trial is a single-center, open-label, fixed-sequence, two-period study with a total duration of about 56 days per participant, including a 28-day screening period and a 19-day assessment period.² Enrollment is estimated at 17 participants.²