Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Povetacicept · 6 trials · 11 indications
| Arm | Type | Description |
|---|---|---|
| Povetacicept | EXPERIMENTAL | Participants will be randomized to receive Povetacicept. |
| Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to Povetacicept. |
| Phase 2b: Povetacicept | EXPERIMENTAL | Participants will be randomized to receive one of the two doses of Povetacicept. |
| Phase 3: Povetacicept | EXPERIMENTAL | Participants will be randomized to receive one of the two doses of Povetacicept (dose selected based on Phase 2b). |
| Phase 3: Calcineurin Inhibitor (CNI) | ACTIVE_COMPARATOR | Participants will be randomized to receive the calcineurin inhibitor (CNI) Tacrolimus. |
| Part A1: Povetacicept Bioavailability | EXPERIMENTAL | Participants will be randomized to receive one of the two Povetacicept formulations. |
| Part A2: Povetacicept Bioavailability | EXPERIMENTAL | Participants will be randomized to receive one of the two Povetacicept formulations. |
| Part B1: Povetacicept Bioequivalence | EXPERIMENTAL | Participants will be randomized to receive one of the two Povetacicept presentations. |
| Part B2: Povetacicept Bioequivalence | EXPERIMENTAL | Participants will be randomized to receive one of the two Povetacicept presentations. |
| Part 1: Povetacicept 240mg | EXPERIMENTAL | Participants grouped in 3 cohorts by diagnosis will be administered Povetacicept |
| Part 2: Povetacicept Dose A | EXPERIMENTAL | Based on the findings of Part 1, one or two dose levels may be assessed in Part 2; if two dose levels are assessed participants will be randomized to receive one of the two dose levels of Povetacicept |
| Name | Type | Description |
|---|---|---|
| Povetacicept | DRUG | Subcutaneous injection administration. |
| Placebo (matched to Povetacicept) | DRUG | Placebo matched to Povetacicept subcutaneous injection administration. |
| Placebo | DRUG | Solution for Subcutaneous Injection. |
| Tacrolimus | DRUG | Capsules for Oral Administration. |
Key Inclusion Criteria: * Diagnosed IgAN, with biopsy confirmation * 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g * Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2 * Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) ...