Study of ABBV-CLS-628 Infusions to Assess Safety and Effects in Adults Aged 18 to 55 With Autosomal Dominant Polycystic Kidney Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ABBV-CLS-628, an investigational drug, for treating adults with Autosomal Dominant Polycystic Kidney Disease ADPKD, a genetic condition that causes fluid-filled cysts to develop in the kidneys. This Phase 2 study involves about 240 adult participants aged 18 to 55 with specific classifications of ADPKD and certain kidney function levels. Participants are randomly assigned to one of four groups, receiving either one of three different doses of ABBV-CLS-628 or a placebo. The treatment is given as an intravenous infusion every four weeks for 92 weeks. After the treatment period, participants will be followed for up to 15 weeks to monitor ongoing effects. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, safety monitoring, and completing questionnaires. Researchers will measure changes in total kidney volume and kidney function over time, as well as record any adverse events. The study monitors participants closely to evaluate both the benefits and risks of the treatment throughout the nearly two-year participation period.

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