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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 an investigational small molecule being developed for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). It is currently in Phase 2 clinical development and is administered as an intravenous infusion to adult participants with ADPKD.
ABBV-CLS-628 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The drug is currently in Phase 2 clinical trials for 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 regulatory authorities. A Phase 2 study is currently recruiting participants to evaluate the drug's safety and effectiveness in adults with Autosomal Dominant Polycystic Kidney Disease.
ABBV-CLS-628 is being studied in a Phase 2 clinical trial with the identifier NCT06902558. This randomized, double-blind, placebo-controlled study is recruiting approximately 240 adult participants with Autosomal Dominant Polycystic Kidney Disease across multiple countries, including the United States, Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Portugal, South Korea, and Spain.
No alternative names for ABBV-CLS-628 have been disclosed. The drug is identified solely by its code name ABBV-CLS-628 in clinical trial registrations and is being investigated for Autosomal Dominant Polycystic Kidney Disease.