Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-CLS-628 · 1 trial · 1 indication
TKV will be determined from manual contours of the kidneys on 3D magnetic resonance imaging (MRI), performed by imaging specialists and verified by independent radiologists with expertise in Autosomal Dominant Polycystic Kidney Disease (ADPKD).
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| ABBV-CLS-628 Dose A | EXPERIMENTAL | Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks. |
| ABBV-CLS-628 Dose B | EXPERIMENTAL | Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks. |
| ABBV-CLS-628 Dose C | EXPERIMENTAL | Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks. |
| Name | Type | Description |
|---|---|---|
| ABBV-CLS-628 | DRUG | IntraVenous Infusion |
| Placebo | DRUG | IntraVenous Infusion |
Inclusion Criteria: * Autosomal Dominant Polycystic Kidney Disease (ADPKD) Class 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD. * Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/1.73 m\^2 and \< 90 mL/min/1.73 m\^2, using the Chronic Kidney Disease Epidemiology Co...
ABBV-CLS-628 is being studied for the treatment of autosomal dominant polycystic kidney disease (ADPKD), a genetic kidney disorder. It is an investigational small molecule therapeutic in Phase 2 development. No approved indication has been established for this drug.
ABBV-CLS-628 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the drug in autosomal dominant polycystic kidney disease.
ABBV-CLS-628 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 study is currently recruiting adult participants with autosomal dominant polycystic kidney disease.
ABBV-CLS-628 is being evaluated in one active clinical trial, NCT06902558, a Phase 2 study assessing adverse events and effectiveness of intravenous infusions in adults with autosomal dominant polycystic kidney disease. The trial is recruiting and plans to enroll 240 participants across the United States, Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Portugal, South Korea, and Spain.
The Phase 2 trial of ABBV-CLS-628, NCT06902558, is a randomized, double-blind, placebo-controlled study. It plans to enroll 240 adults aged 18 and older with autosomal dominant polycystic kidney disease and is currently recruiting. Participants receive intravenous infusions, and the study is not limited to biomarker-selected patients.