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Label indication UPLIZNA is a CD19-directed cytolytic antibody indicated for the treatment of: Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. ( 1.1 ) Immunoglobulin G4-related disease (IgG4-RD) in adult patients. FDA label
Also known as AMG 335, Uplizna®, MEDI-551, VIB0551
Inebilizumab · 8 trials · 10 indications
Participants who met the two outcomes combined will be reported for this endpoint.
Time to disease flare was defined as the number of days from Day 1 (dosing) to the date of the first treated and Adjudication Committee (AC)-determined IgG4-RD flare within the 52-week RCP. The date of disease flare was determined by the initiation of any flare treatment, including new or increased glucocorticoid (GC) treatment, other immunotherapy, or an interventional procedure, as deemed necessary by the Investigator to address the flare. Kaplan-Meier (KM) method was used to estimate the median time to flare, and 95% confidence interval (CI).
MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease Outcome measure is reported for the overall population.
| Arm | Type | Description |
|---|---|---|
| Part 1: Inebilizumab | EXPERIMENTAL | Participants will receive inebilizumab as an intravenous (IV) infusion in addition to standard of care (SOC). |
| Part 1: Placebo | EXPERIMENTAL | Participants will receive placebo as an IV infusion in addition to SOC. |
| Part 2: Inebilizumab | EXPERIMENTAL | Participants will receive Inebilizumab as an IV infusion in addition to SOC. |
| Part 2: Placebo | EXPERIMENTAL | Participants will receive placebo as an IV infusion in addition to SOC. |
| Inebilizumab | EXPERIMENTAL | Participants will receive inebilizumab via intravenous (IV) infusion |
| Tacrolimus | ACTIVE_COMPARATOR | Participants will receive tacrolimus orally. |
| VIB0551 | EXPERIMENTAL | Inebilizumab administered as an IV infusion. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered as an IV infusion. |
| Inebilizumab, (AChR-Ab+) MG | EXPERIMENTAL | Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the RCP. Participants who elect to enter the open label phase (OLP) will receive inebilizumab administered IV on OLP Days 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911. |
| Placebo, (AChR-Ab+) MG | PLACEBO_COMPARATOR | Participants will receive placebo administered IV on Days 1, 15, and 183 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911. |
| Inebilizumab, (MuSK-Ab+) MG | EXPERIMENTAL | Participants will receive inebilizumab administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Day 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911. |
| Placebo, (MuSK-Ab+) MG | PLACEBO_COMPARATOR | Participants will receive placebo administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911. |
| Subprotocol A: Inebilizumab 3 Doses | EXPERIMENTAL | Participants will receive 3 doses of inebilizumab administered via an intravenous (IV) infusion. |
| Subprotocol A: Inebilizumab 4 Doses | EXPERIMENTAL | Participants will receive 4 doses of inebilizumab administered via an IV infusion. |
| Subprotocol B Part A: Blinatumomab Low-dose | EXPERIMENTAL | Participants will receive blinatumomab low-dose administered via SC injection. |
| Subprotocol B Part A: Blinatumomab Medium-dose | EXPERIMENTAL | Participants will receive blinatumomab medium-dose administered via SC injection. |
| Subprotocol B Part A: Blinatumomab High-dose | EXPERIMENTAL | Participants will receive blinatumomab high-dose administered via SC injection. |
| Subprotocol B Part B: Dose Expansion | EXPERIMENTAL | Participants will receive blinatumomab at a dose which will be determined during Subprotocol B Part A. |
| Subprotocol C Part A: Blinatumomab Low-dose | EXPERIMENTAL | Participants will receive blinatumomab low-dose administered via SC injection during Subprotocol C Part A. |
| Subprotocol C Part A: Blinatumomab Medium-dose | EXPERIMENTAL | Participants will receive blinatumomab medium-dose administered via SC injection during Subprotocol C Part A. |
| Subprotocol C Part A: Blinatumomab High-dose | EXPERIMENTAL | Participants will receive blinatumomab high-dose administered via SC injection during Subprotocol C Part A. |
| Subprotocol C Part B: Dose Expansion | EXPERIMENTAL | Participants will receive blinatumomab at a dose which will be determined during Subprotocol C Part A. |
| Name | Type | Description |
|---|---|---|
| Inebilizumab | DRUG | Inebilizumab will be administered as an IV infusion. |
| Placebo | DRUG | Placebo will be administered as IV infusion. |
| Standard of Care | OTHER | Standard of Care |
| Tacrolimus | DRUG | Tacrolimus will be administered orally |
| IV Placebo | DRUG | Participants will receive IV placebo matched to inebilizumab |
| Blinatumomab | DRUG | SC Injection |
Inclusion Criteria: * Signed informed consent. * Age ≥ 18 years or legal adult age within the country, whichever is older and \< 75 years at the time of signing the informed consent. * Participants must have either inadequate response to at least 9 months of SOC or are intolerant to SOC within 6 mo...
Inebilizumab is an investigational monoclonal antibody developed by Amgen Inc. (ticker AMGN) for immunology indications. It is being studied in autoimmune hepatitis, generalized myasthenia gravis, primary membranous nephropathy, and immunoglobulin G4-related disease. It is in Phase 3 clinical development and is not described as an approved therapy in these programs.
Inebilizumab targets CD19, a marker on B cells. By binding CD19, the monoclonal antibody is designed to act on B cells, the immune cell population implicated in antibody-mediated autoimmune conditions. This CD19-directed mechanism underlies its study across autoimmune hepatitis, generalized myasthenia gravis, membranous nephropathy, and IgG4-related disease.
Inebilizumab is developed by Amgen Inc., which trades under the ticker AMGN. Amgen is running the Phase 3 and Phase 2 studies of inebilizumab in autoimmune hepatitis, primary membranous nephropathy, generalized myasthenia gravis, and immunoglobulin G4-related disease across sites in the United States and several other countries.
Inebilizumab is in Phase 3 development for autoimmune hepatitis and primary membranous nephropathy, and in Phase 2 development for generalized myasthenia gravis and immunoglobulin G4-related disease in pediatric patients. It is an investigational agent in these programs and is being evaluated in controlled, randomized, double-blind clinical trials.
Inebilizumab trials include NCT07851220, a Phase 3 study in primary membranous nephropathy recruiting in the United States, and NCT07598825, a Phase 3 trial in autoimmune hepatitis recruiting in the United States, Canada, and China. Pediatric studies include NCT07222553 in IgG4-related disease and NCT06987539 in generalized myasthenia gravis, both enrolling children from age 2.