Approval Probability
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Also known as ALPN-303
Povetacicept · 7 trials · 11 indications
Type, incidence, and severity of TEAE as assessed by CTCAE
| Arm | Type | Description |
|---|---|---|
| Povetacicept | EXPERIMENTAL | Participants will receive Povetacicept every 4 weeks (Q4W) for 104 weeks. |
| 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 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. |
| ALPN-303 Regimen A | EXPERIMENTAL | - |
| Placebo Regimen A | PLACEBO_COMPARATOR | - |
| ALPN-303 Regimen B | EXPERIMENTAL | - |
| Placebo Regimen B | PLACEBO_COMPARATOR | - |
| 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. |
| ALPN-303 | DRUG | Multiple dose levels will be evaluated. |
Key Inclusion Criteria: * Completed the Week 104 visit in the parent study VX24-AIS-D08 (NCT06564142) and has not permanently discontinued study drug * Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 15 milliliters per minute (mL/min)/1.73 square meter (m\^2) within 45 days...
Povetacicept is an investigational small molecule therapeutic being developed by Vertex Pharmaceuticals Incorporated for immune-mediated and hematologic conditions. Its clinical development covers Immunoglobulin A Nephropathy, Primary Membranous Nephropathy, Lupus Nephritis, Idiopathic Thrombocytopenic Purpura, and Generalized Myasthenia Gravis. It is not yet approved and remains in clinical development.
Povetacicept is being studied for Immunoglobulin A Nephropathy, Primary Membranous Nephropathy, Lupus Nephritis, Idiopathic Thrombocytopenic Purpura, and Generalized Myasthenia Gravis. The most advanced program is in Immunoglobulin A Nephropathy, where it is being evaluated in Phase 3 trials. It is investigational and has not been approved for any indication.
Povetacicept is developed by Vertex Pharmaceuticals Incorporated, which trades on the Nasdaq under the ticker VRTX. Vertex is running the clinical program across nephrology, hematology, and neuromuscular indications, including Phase 3 studies in Immunoglobulin A Nephropathy and Phase 2 studies in Primary Membranous Nephropathy and Generalized Myasthenia Gravis.
Povetacicept is in Phase 3 development for Immunoglobulin A Nephropathy and Phase 2 development for Primary Membranous Nephropathy and Generalized Myasthenia Gravis. It is an investigational agent and has not received FDA approval. Additional indications, including Lupus Nephritis and Idiopathic Thrombocytopenic Purpura, are also part of its development program.
Povetacicept trials include NCT06564142, a Phase 3 study in Immunoglobulin A Nephropathy that is active but not recruiting, and NCT07807995, a Phase 3 open-label long-term treatment study in the same indication enrolling by invitation. Phase 2 studies include NCT07501702 in Generalized Myasthenia Gravis and NCT07204275 in Primary Membranous Nephropathy, both recruiting.
The Povetacicept clinical program has a combined planned enrollment of about 1,210 participants across its studies. The Phase 3 Immunoglobulin A Nephropathy trials each plan 605 participants, the Phase 2 Primary Membranous Nephropathy study plans 176, and the Phase 2 Generalized Myasthenia Gravis study plans 30. All trials enroll adults 18 years and older.