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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05852938 | A Study of Zigakibart in Adults With IgA Nephropathy | PHASE3 | ACTIVE NOT_RECRUITING | 383 | — | — | Jul 6, 2023 | Jan 25, 2028 | Apr 1, 2026 | 200 | United States, Argentina +21 |
| NCT03945318 | Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN) | PHASE1 | ACTIVE NOT_RECRUITING | 103 | — | — | Apr 8, 2019 | Apr 30, 2026 | Apr 20, 2026 | 16 | United States, South Korea +1 |
Change from Baseline to Week 104 in eGFR using the CKD-EPI 2021 creatinine equation
| Arm | Type | Description |
|---|---|---|
| BION-1301 | EXPERIMENTAL | 600mg subcutaneous administration every 2 weeks for 104 weeks |
| Placebo | PLACEBO_COMPARATOR | subcutaneous administration every 2 weeks for 104 weeks |
| Part 1: BION-1301 | EXPERIMENTAL | Up to 5 cohorts with single ascending doses of BION-1301 administered by intravenous (IV) infusion. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo administered by IV infusion. |
| Part 2: BION-1301 | EXPERIMENTAL | Up to 4 cohorts with multiple doses of BION-1301 administered by intravenous (IV) infusion. |
| Part 2: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo by IV infusion. |
| Part 3: BION-1301 | EXPERIMENTAL | Two cohorts of participants will receive multiple doses of BION-1301 by IV infusion (Cohort 1) or SC injection (Cohort 2) at 600mg/biweekly. |
| Part 4 Retreatment: BION-1301 | EXPERIMENTAL | Eligible participants from Part 3 may enroll in Part 4 due to disease progression or by choice for optional retreatment and receive SC injection at 600mg/biweekly. |
| Name | Type | Description |
|---|---|---|
| BION-1301 | DRUG | BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks. |
| Placebo | DRUG | Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks. |
| BION-1301 Single Dose | DRUG | A solution for IV infusion administered as a single dose. |
| Placebo Single Dose | DRUG | A solution by IV infusion administered as a single dose. |
| BION-1301 Multiple Doses | DRUG | A solution for IV infusion or SC injections (Part 3 only) administered as multiple doses. |
| Placebo Multiple Doses | DRUG | A solution by IV infusion administered as multiple doses. |
Inclusion Criteria: * Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures. * Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investig...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 11 | PHASE3 | BION-1301, LNP023, Atrasentan, Zigakibart, zigakibart |
| Vera Therapeutics, Inc. Class A | VERA | 4 | PHASE3 | Atacicept |
| Travere Therapeutics, Inc. | TVTX | 2 | PHASE3 | sparsentan, irbesartan, Dapagliflozin, Sparsentan |
| Biogen Inc. | BIIB | 1 | PHASE3 | Felzartamab |
| Vertex Pharmaceuticals Incorporated | VRTX | 2 | PHASE3 | Povetacicept |
| AstraZeneca PLC | AZN | 2 | PHASE3 | Ravulizumab |
| Biohaven Ltd. | BHVN | 1 | PHASE1 | BHV-1400 |
| Jade Biosciences, Inc. | JBIO | 1 | PHASE2 | JADE101 |