Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Inebilizumab · 7 trials · 9 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. |
| 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. |
| Inebilizumab | EXPERIMENTAL | Participants will receive Inebilizumab via intravenous (IV) infusion. |
| 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 |
| 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 drug being studied for several autoimmune conditions, including IgG4-related disease, neuromyelitis optica spectrum disorder, generalized myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, and myasthenia gravis. It is in Phase 3 clinical development for most of these indications.
Inebilizumab targets CD19, a protein found on B cells. By binding to CD19, it is designed to deplete B cells, which are involved in the immune response that drives autoimmune diseases. This mechanism is being evaluated in conditions like myasthenia gravis and IgG4-related disease.
Inebilizumab is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical trials to evaluate the drug's safety and efficacy in multiple autoimmune indications.
Inebilizumab is in Phase 3 clinical development for several indications, including myasthenia gravis, IgG4-related disease, and autoimmune hepatitis. It is also being studied in a Phase 2 master protocol for systemic lupus erythematosus. The drug is investigational and not yet approved.
Inebilizumab is being evaluated in multiple trials, including NCT04524273 for myasthenia gravis, NCT04540497 for IgG4-related disease, NCT06570798 for systemic lupus erythematosus, and NCT07598825 for autoimmune hepatitis. These trials are in Phase 2 or Phase 3 and are actively recruiting or ongoing.
Inebilizumab is also known by the brand name Uplizna in some contexts. The drug is being studied under the name Inebilizumab in clinical trials for conditions like myasthenia gravis and IgG4-related disease, and it targets CD19 on B cells.