A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABBV-CLS-628 in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease ADPKD

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ABBV-CLS-628, an investigational drug, for adults with Autosomal Dominant Polycystic Kidney Disease ADPKD, a common genetic kidney disorder that causes cysts to grow in the kidneys. This Phase 2 study involves about 240 adult participants worldwide and aims to understand how the treatment affects kidney size and kidney function over time. Participants are randomly assigned to one of four groups, receiving either one of three different doses of ABBV-CLS-628 or a placebo. The drug or placebo is given through an intravenous infusion every 4 weeks for a total of 92 weeks. After this treatment period, participants will be followed for up to 15 additional weeks to monitor ongoing effects and safety. During the study, participants will regularly visit a hospital or clinic for medical assessments, blood tests, side effect checks, and questionnaires. Researchers will track changes in total kidney volume and kidney function, along with any adverse events. The study will last approximately 107 weeks, including treatment and follow-up, to carefully monitor participants health and treatment impact.

ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)