The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).
Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.
This trial was terminated before completion. Termination can indicate safety signals, futility findings, or business/regulatory decisions by the sponsor.
Amgen Inc (AMGN) is the sponsoring company for this trial. BiotechSign currently grades this company C (52/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.