In short
Clinical trials are studying ABBV-CLS-628 in adults with autosomal dominant polycystic kidney disease (ADPKD). These trials aim to assess safety and how well the treatment works, including changes in kidney size measured over time.
Key points
- ABBV-CLS-628 is being studied in adults with autosomal dominant polycystic kidney disease (ADPKD). The trial is a Phase 2 interventional study and includes ABBV-CLS-628 and placebo. Researchers want to assess safety and efficacy, with the main result focused on change in total kidney volume measured by MRI at Week 96. The study plans to enroll 240 participants. This trial is authorised and is designed to learn whether the treatment may help people with ADPKD.
Clinical trials overview
The available trial is studying ABBV-CLS-628 in adults with autosomal dominant polycystic kidney disease (ADPKD), a condition in which many cysts can grow in the kidneys and make them larger over time.
The study is designed to assess both safety and efficacy, which means researchers want to learn whether the treatment can be used safely and whether it may help people with the disease.
Who can participate
This trial is for adult subjects with ADPKD.
The source data does not list more detailed eligibility rules, so the full entry requirements are not available here.
Study design and treatment groups
This is an interventional study, which means researchers give a study treatment and then compare outcomes over time.
The trial includes two groups: ABBV-CLS-628 and placebo, which is a look-alike treatment without the active study drug.
The study is in Phase 2, a stage that usually looks more closely at whether a treatment may work while continuing to monitor safety.
What the trial measures
The main result, called the primary outcome, is the cumulative rate of change from baseline in total kidney volume (TKV) by MRI at Week 96.
TKV means the combined size of both kidneys, and MRI is a scan that makes detailed pictures of the inside of the body.
“From baseline” means the result is compared with the starting point before treatment begins.
Trial status and size
The trial is listed as Authorised.
The planned enrollment is 240 people, which gives researchers a larger group to compare ABBV-CLS-628 with placebo.