Abbvie ((ABBV)), Abbvie (($CC:ABBV.CUR)) announced an update on their ongoing clinical study.
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AbbVie has initiated a Phase 2 clinical study to evaluate the safety and efficacy of ABBV-CLS-628, an investigational drug for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). The study aims to assess adverse events and the drug’s effectiveness in adult participants with ADPKD, a common genetic cause of kidney disease characterized by fluid-filled cysts in the kidneys.
The intervention involves intravenous infusions of ABBV-CLS-628 or a placebo, administered every four weeks over a 92-week period. Participants are randomly assigned to one of four groups, with a 25% chance of receiving a placebo. The study will enroll approximately 240 participants across 100 global sites.
This interventional study employs a randomized, parallel assignment model with quadruple masking, ensuring that participants, care providers, investigators, and outcomes assessors remain unaware of group allocations. The primary purpose of the study is treatment-focused.
The study commenced on June 9, 2025, with an anticipated primary completion date yet to be specified. The last update was submitted on August 5, 2025. These timelines are crucial for tracking the study’s progress and potential market entry of ABBV-CLS-628.
The successful development of ABBV-CLS-628 could significantly impact AbbVie’s stock performance by expanding its portfolio in the renal disease market. This development is particularly relevant given the competitive landscape, where advancements in genetic kidney disease treatments are closely watched by investors.
The study is currently recruiting, with further details accessible on the ClinicalTrials portal.