Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06902558 | A Study to Assess Adverse Events and Effectiveness of IntraVenous Infusions of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | PHASE2 | RECRUITING | 240 | — | — | Jun 9, 2025 | Aug 1, 2029 | Feb 4, 2026 | 75 | United States, Australia +9 |
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...