Biogen Inc. ((BIIB)), Biogen ((CC:HTER)) announced an update on their ongoing clinical study.
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Biogen Inc. (BIIB) is conducting a Phase 3 long-term extension study titled A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus. The study aims to assess the long-term safety and efficacy of litifilimab, a drug intended to manage symptoms of systemic lupus erythematosus (SLE) in adults who have completed previous treatment periods. This study is significant as it seeks to provide insights into the drug’s safety profile and its potential to improve patient outcomes over an extended period.
The intervention being tested is litifilimab, administered as subcutaneous injections every four weeks. The study includes two arms: a low dose and a high dose of litifilimab, with participants continuing their standard care medications. The primary purpose is to evaluate the treatment’s safety and its effect on SLE symptoms.
The study design is interventional, with participants randomly allocated to different treatment arms. It follows a parallel intervention model with quadruple masking, meaning neither participants nor care providers, investigators, or outcomes assessors know which dose is being administered. The primary goal is treatment-focused.
The study began on June 10, 2022, and is currently enrolling by invitation. The primary completion and estimated study completion dates are not specified, but the last update was submitted on August 14, 2025. These dates are crucial for tracking the study’s progress and anticipating when results might be available.
This study update could influence Biogen’s stock performance and investor sentiment, as positive results may enhance the company’s market position in the lupus treatment space. Investors should also consider the competitive landscape, as advancements in lupus treatments could impact Biogen’s market share.
The study is ongoing, and further details are available on the ClinicalTrials portal.