Biogen Inc. ((BIIB)), Biogen ((CC:HTER)) announced an update on their ongoing clinical study.
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Biogen Inc. (BIIB) is currently recruiting participants for a Phase 3 clinical study titled A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL). The study aims to evaluate the effects of felzartamab on proteinuria in adults with Immunoglobulin A nephropathy (IgAN), a condition characterized by kidney damage leading to protein in the urine. The primary objective is to assess the change in protein levels in urine over 36 weeks, alongside evaluating kidney function and the safety profile of felzartamab.
The study involves the administration of felzartamab, an intravenous drug, compared to a placebo. Felzartamab is designed to reduce proteinuria and improve kidney function in IgAN patients. Participants will receive either felzartamab or a placebo through IV infusions over a 24-week treatment period, followed by an 80-week follow-up period.
This study is structured as a randomized, double-blind, placebo-controlled trial with a parallel intervention model. It involves quadruple masking, meaning that participants, care providers, investigators, and outcomes assessors are all blinded to the treatment allocation. The primary purpose of the study is treatment-focused.
The study officially started on May 8, 2025, with the primary completion and estimated completion dates yet to be announced. The last update was submitted on August 11, 2025. These dates are crucial for tracking the study’s progress and potential market impact.
Biogen’s involvement in this study could significantly influence its stock performance and investor sentiment, particularly if felzartamab proves effective. The outcome could also affect the competitive landscape in the treatment of IgAN, where Biogen is collaborating with Human Immunology Biosciences, Inc. (HI-Bio).
The study is ongoing, with further details available on the ClinicalTrials portal.