In short
Clinical trials are investigating Inebilizumab in several diseases, including anti-NMDAR encephalitis, NMOSD, myasthenia gravis, and IgG4-related disease. These studies look at safety, effectiveness, and how the treatment behaves in adults and children. Some trials compare Inebilizumab with placebo, while others are open-label studies.
Key points
- Inebilizumab is being studied in several clinical trials for immune-related diseases, including anti-NMDAR encephalitis, NMOSD, myasthenia gravis, and IgG4-related disease. The trials include both adults and children, with study phases 2 and 3. Some studies compare Inebilizumab with placebo, while others are open-label studies that follow all participants on treatment. Main outcomes include disability, disease flare, safety, tolerability, and changes in B-cell counts. Several trials also measure pharmacokinetics, which shows how the treatment moves through the body. Overall, the research is focused on whether Inebilizumab can help these patient groups and how safe it is to use in them.
Trial overview
The clinical trials in this set study Inebilizumab in people with different immune-related diseases. The trials are looking at whether the treatment can improve disease control, reduce disability, or lower the risk of flare-ups, while also checking safety and tolerability.
Conditions being studied
One Phase 2 trial studies anti-N-methyl-D-aspartate receptor encephalitis, also called anti-NMDAR encephalitis, in which the main goal is to compare disability after treatment with Inebilizumab versus placebo.
Another Phase 2 trial studies neuromyelitis optica spectrum disorder, also called NMOSD, in children and adolescents. The trial title also notes older names for this condition, including Devic's syndrome and neuromyelitis optica (NMO).
Two trials study myasthenia gravis: one in adults with AChR-Ab+ or MuSK-Ab+ disease, and one in children with generalized myasthenia gravis (gMG). Two trials study IgG4-related disease, one in adults and one in pediatric participants.
Study designs and phases
The trials are split between Phase 2 and Phase 3 studies.
The Phase 3 studies are in adults with myasthenia gravis and IgG4-related disease, and both are designed to test whether Inebilizumab works better than control treatment in larger groups. The anti-NMDAR encephalitis and adult IgG4-related disease trials are randomized and placebo-controlled, meaning participants are assigned by chance and some receive placebo for comparison.
The pediatric NMOSD, pediatric IgG4-related disease, and pediatric gMG studies are open-label or uncontrolled, which means everyone in the study receives the study treatment and there is no placebo group in the trial description.
Who can take part
These studies include different age groups and diagnoses, so eligibility depends on the trial.
- Adults with myasthenia gravis due to AChR antibodies or MuSK antibodies are included in one Phase 3 trial.
- Children and adolescents with NMOSD are included in one Phase 2 trial.
- Adults with IgG4-related disease are included in one Phase 3 trial.
- Children with IgG4-related disease are included in one Phase 2 trial.
- Children with generalized myasthenia gravis are included in one Phase 2 trial.
- Patients with anti-NMDAR encephalitis are included in one Phase 2 trial that measures disability and safety over time.
Main outcomes being measured
The main outcome in the anti-NMDAR encephalitis study is the change in mRS at 16 weeks, which is a scale used to measure disability and daily function. That trial also measures safety by counting treatment-emergent adverse events and serious adverse events up to 24 weeks.
In the adult myasthenia gravis trial, the main outcome is the change from baseline in MG-ADL score at Week 26 in the full study population, including both AChR-Ab+ and MuSK-Ab+ participants. MG-ADL is a daily living score that reflects how much the disease affects common activities.
The adult IgG4-related disease trial measures time to disease flare over a 52-week period. A flare means the disease gets worse and needs new or stronger treatment, such as glucocorticoids, other immunotherapy, or a procedure.
The pediatric NMOSD, pediatric IgG4-related disease, and pediatric gMG studies all include pharmacokinetic measures, B-cell counts, and safety outcomes such as adverse events, serious adverse events, laboratory changes, and vital signs.
Key trial details
- NCT04372615 is a Phase 2 trial in anti-NMDAR encephalitis with 116 participants and a placebo-controlled design. It compares disability at 16 weeks and tracks safety through 24 weeks.
- NCT05549258 is a Phase 2 pediatric trial in NMOSD with 15 participants. It focuses on pharmacokinetics, B-cell counts, and safety.
- NCT04524273 is a Phase 3 adult myasthenia gravis trial with 230 participants. It measures change in MG-ADL at Week 26.
- NCT04540497 is a Phase 3 adult IgG4-related disease trial with 200 participants. It measures time to disease flare over 52 weeks and uses a placebo control.
- NCT07222553 is a Phase 2 pediatric IgG4-related disease trial with 15 participants. It studies pharmacokinetics, B-cell counts, and safety.
- NCT06987539 is a Phase 2 pediatric generalized myasthenia gravis trial with 12 participants. It also measures pharmacokinetics, B-cell counts, and safety.