What Is Inebilizumab?
Inebilizumab is an FDA-approved medication for Neuromyelitis Optica Spectrum Disorder (NMOSD). NMOSD is a rare autoimmune condition primarily affecting the optic nerves and spinal cord, leading to severe symptoms such as vision loss, paralysis, and significant pain. The specific mechanism of action for Inebilizumab is not detailed in the provided trial descriptions, but it is administered as an intravenous infusion.
Beyond its approved use, Inebilizumab is also being investigated in clinical trials for a range of other autoimmune and inflammatory conditions, including autoimmune encephalitis, autoimmune hepatitis, generalized myasthenia gravis, and IgG4 related disease. Its role in these conditions is being studied to assess its effectiveness and safety.
Uses and Conditions Under Study
Inebilizumab is primarily studied for Neuromyelitis Optica Spectrum Disorder (NMOSD), with a total of five trials focusing on this condition. NMOSD is an autoimmune inflammatory disorder that can cause blindness, severe muscle weakness, paralysis, and pain. Research objectives include investigating Inebilizumab's steroid-sparing effect, safety in treatment-naïve patients, and efficacy during acute attacks.
The drug is also under investigation for a variety of other autoimmune conditions. These include Autoimmune Diseases (1 trial), Autoimmune Encephalitis (1 trial), Autoimmune Hepatitis (1 trial), Demyelinating Autoimmune Diseases, CNS (1 trial), and Encephalitis (1 trial). Additionally, Inebilizumab is being studied for IgG4 Related Disease (1 trial), a chronic fibroinflammatory condition, and Generalized Myasthenia Gravis (1 trial), a neuromuscular autoimmune disorder characterized by muscle weakness.
One trial is exploring Inebilizumab's use in Highly Sensitized Patients on Waiting List for Kidney Transplantation. This research aims to understand if the drug can help reduce immune sensitization in patients awaiting a kidney transplant, potentially improving transplant outcomes.
Dosing
Inebilizumab is administered as an intravenous infusion. Various dosing regimens have been studied in clinical trials. One regimen involves administering 1000 mg at weeks 0 and 2, followed by 1000 mg every 6 months thereafter. Another studied regimen includes a 300 mg intravenous infusion on Day 6 (Week 0), Day 20 (Week 2), and then a third dose at Week 24.
A different dosing schedule for 300 mg involves infusions on Day 1 and Day 15, followed by 300 mg infusions every 26 weeks. In some trials, Inebilizumab is given with concomitant therapy. For instance, Prednisone at a daily dose of 60 mg was initiated alongside Inebilizumab, with a subsequent tapering schedule involving a reduction of 5 mg every 2 weeks until reaching 20 mg/day.
Side Effects
In clinical trials involving up to 629 patients, the most common side effects reported with Inebilizumab were:
- Nasopharyngitis (sore throat and runny nose), experienced by 10.3% of patients taking Inebilizumab, compared to 7.4% on placebo.
- Headache, reported by 9.9% of patients on Inebilizumab, compared to 11.6% on placebo.
- Urinary tract infection, occurring in 9.7% of patients on Inebilizumab, compared to 11.2% on placebo.
- Upper respiratory tract infection, seen in 9.1% of patients on Inebilizumab, compared to 10.3% on placebo.
- Arthralgia (joint pain), affecting 6.5% of patients on Inebilizumab, compared to 11.2% on placebo.
- Cough, reported by 6.2% of patients on Inebilizumab, which was the same as 6.2% on placebo.
- Diarrhea, experienced by 4.0% of patients on Inebilizumab, compared to 10.3% on placebo.
Other side effects reported in studies with smaller patient groups included influenza (9.8% on Inebilizumab vs 7.1% on placebo in a study with 17
Currently Recruiting Trials
Several clinical trials are actively recruiting participants to further understand the potential of inebilizumab across a range of autoimmune conditions. These studies aim to gather more information about how the medication works, its safety, and its effectiveness in different patient populations. One ongoing Phase 2 study, NCT06987539, sponsored by Amgen, is evaluating inebilizumab in children with generalized myasthenia gravis (gMG). This study aims to characterize how the drug moves through the body (pharmacokinetics) and its effects (pharmacodynamics), as well as its safety and tolerability in pediatric participants. It plans to enroll up to 15 children. Another significant Phase 2 master protocol, NCT06570798, also sponsored by Amgen, is assessing inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis. This comprehensive study has an enrollment target of 220 participants and explores different dosing regimens. For individuals with acute neuromyelitis optica spectrum disorders (NMOSD), Xuanwu Hospital, Beijing, is sponsoring a study, NCT05891379, to observe the effectiveness and safety of inebilizumab during the acute phase of the condition. This study aims to enroll 50 participants. Additionally, a Phase 2, open-label, multicenter study, NCT05549258, sponsored by Amgen, is investigating inebilizumab in pediatric participants between 2 and 18 years of age with recently active NMOSD. This study focuses on pharmacokinetics, pharmacodynamics, and safety, targeting 15 participants. Finally, the University of Utah is sponsoring "The ExTINGUISH Trial" (NCT04372615), a Phase 2 study investigating inebilizumab in anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis. This trial seeks to determine the difference in outcomes at 16 weeks for participants receiving inebilizumab alongside standard-of-care immunomodulatory therapies, compared to placebo. It plans to enroll 116 participants.Where to Participate
Clinical trials for inebilizumab are actively recruiting across a wide geographic area, with sites established in 23 states and 40 cities. This broad reach helps ensure diverse participation and accessibility for potential volunteers. The top locations with multiple recruiting sites include:- Boston, Massachusetts (3 sites)
- Aurora, Colorado (3 sites)
- New York, New York (3 sites)
- Cleveland, Ohio (2 sites)
- Scottsdale, Arizona (2 sites)
- Orange, California (2 sites)
- Miami, Florida (2 sites)
- Chicago, Illinois (2 sites)
- Rochester, Minnesota (2 sites)
- Rochester, New York (2 sites)