Amgen registers Phase 2/3 inebilizumab trial in autoimmune hepatitis
Amgen added a new study testing inebilizumab for autoimmune hepatitis, while a separate FDA label update for ENBREL was sponsored by Immunex, not Amgen.
Amgen registered one new trial for the week and a related ENBREL label change was filed by a different sponsor.
- "A Phase 2/3, Randomized, Double-blind, Multicenter, Placebo-controlled Study of Inebilizumab in Participants With Autoimmune Hepatitis" (NCT07598825, acronym MERCURY) is recruiting, with Amgen as lead sponsor.1 The trial aims to evaluate the safety and tolerability of inebilizumab in Part 1 and its efficacy on disease activity and glucocorticoid use in Part 2.1 It is designed to enroll an estimated 180 participants.1
- A label supplement for ENBREL (etanercept) was approved under BLA103795, but the submission lists IMMUNEX as the sponsor, with a submission status date of 2026-10-142, not Amgen.
- "A Phase 3 Multicenter, Open-label, Single-arm Trial Evaluating Home Self-Administration of Subcutaneous Maridebart Cafraglutide Via Autoinjector in Adult Participants Living With Obesity or Overweight Without Type 2 Diabetes Mellitus" (NCT07871409, acronym MARITIME-PEN) remains not yet recruiting, with an estimated start of October 28, 2026.3 It plans to enroll an estimated 230 participants.3
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.