Inebilizumab

DRUG18 trials

Sponsors

Horizon Therapeutics Ireland Designated Activity Company, MedImmune LLC, Amgen, University of Utah, Tanabe Pharma Corporation

Conditions

Active Refractory Rheumatoid ArthritisAutoimmune EncephalitisEncephalitisGeneralized Myasthenia GravisHighly Sensitized Patients on Waiting List for Kidney TransplantationIgG4 Related DiseaseImmunoglobulin G4-related DiseaseImmunoglobulin G4-related disease (IgG4-RD)

Phase 2

N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

CompletedNCT02200770

MedImmune LLCNeuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Start: 2015-04-01End: 2020-11-06Updated: 2021-12-03

Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor

WithdrawnNCT04174677

AmgenHighly Sensitized Patients on Waiting List for Kidney Transplantation

Start: 2019-12-27End: 2022-04-30Updated: 2024-06-21

The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis

RecruitingNCT04372615

University of UtahAutoimmune Encephalitis, Encephalitis

Start: 2022-03-30End: 2028-09-30Target: 116Updated: 2025-07-01

Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

RecruitingNCT05549258

AmgenNeuromyelitis Optica Spectrum Disorder

Start: 2023-07-03End: 2027-04-13Target: 15Updated: 2025-12-05

An Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects with Neuromyelitis Optica Spectrum Disorder

RecruitingCTIS2023-510007-22-00

Horizon Therapeutics Ireland Designated Activity CompanyNeuromyelitis optica spectrum disorder (NMOSD; also known as Devic's syndrome and previously known as neuromyelitis optica [NMO])

Start: 2022-07-20Target: 5Updated: 2025-08-25

A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases

RecruitingNCT06570798

AmgenActive Refractory Rheumatoid Arthritis, Systemic Lupus Erythematosus

Start: 2025-07-16End: 2029-03-09Target: 220Updated: 2026-02-24

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)

RecruitingNCT06987539

AmgenGeneralized Myasthenia Gravis

Start: 2026-04-30End: 2030-03-13Target: 15Updated: 2026-03-16

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD

Not yet recruitingNCT07222553

AmgenImmunoglobulin G4-related Disease

Start: 2026-04-03End: 2031-06-10Target: 15Updated: 2025-12-22

Phase 3

Myasthenia Gravis Inebilizumab Trial

Active, not recruitingNCT04524273

AmgenMyasthenia Gravis

Start: 2020-10-15End: 2027-11-29Updated: 2026-03-10

A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

Active, not recruitingNCT04540497

AmgenIgG4 Related Disease

Start: 2020-12-04End: 2028-10-31Updated: 2025-12-11

A Study of MT-0551 in Patients With Systemic Sclerosis

Active, not recruitingNCT05198557

Tanabe Pharma CorporationSystemic Sclerosis

Start: 2022-07-20End: 2026-08-31Target: 80Updated: 2025-12-08

A Phase 3, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease.

Active, not recruitingCTIS2023-508290-81-00

Horizon Therapeutics Ireland Designated Activity CompanyImmunoglobulin G4-related disease (IgG4-RD)

Start: 2020-12-18Target: 90Updated: 2025-10-27

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study with Open-Label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults with Myasthenia Gravis [VIB0551.P3.S1 MINT]

Active, not recruitingCTIS2023-510006-40-00

Horizon Therapeutics Ireland Designated Activity CompanyMyasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK).

Start: 2021-03-22Target: 125Updated: 2025-12-05

Phase 4

Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)

Active, not recruitingNCT06180278

AmgenNeuromyelitis Optica Spectrum Disorder

Start: 2024-04-02End: 2028-06-26Updated: 2025-11-21

A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

Not yet recruitingNCT06212245

Hansoh BioMedical R&D CompanyNeuromyelitis Optica Spectrum Disorders

Start: 2024-02-25End: 2025-06-25Target: 33Updated: 2024-01-18

Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD

Not yet recruitingNCT07010302

Massachusetts General HospitalNMOSD

Start: 2026-05-01End: 2030-05-01Target: 540Updated: 2026-03-16

Unknown Phase

Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders

RecruitingNCT05891379

Xuanwu Hospital, BeijingNeuromyelitis Optica Spectrum Disorder

Start: 2024-07-09End: 2025-07-31Target: 50Updated: 2024-09-19

Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders

Feng JinzhouNeuromyelitis Optica Spectrum Disorders

Start: 2023-10-20End: 2025-06-30Target: 80Updated: 2023-10-05

Related Papers

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A Phase 3 Trial of Inebilizumab in Generalized Myasthenia Gravis

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Inebilizumab for Treatment of IgG4-Related Disease

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B cell and aquaporin‐4 antibody relationships with neuromyelitis optica spectrum disorder activity

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Safety and efficacy of inebilizumab for the treatment of neuromyelitis optica spectrum disorder: end-of-study results from the open-label period of the N-MOmentum trial.

2024-06-0126 citations

P.010 Safety and efficacy of inebilizumab in AQP4+ NMOSD participants with history of immunosuppression treatment prior to N-MOmentum study

Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques2024-05-23

P.009 Long-term comparative efficacy of inebilizumab from N-MOmentum participants versus azathioprine and immunosuppressants and placebo in NMOSD patients

Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques2024-05-23

Association of Cytokine Proteins with Disease Activity in Neuromyelitis Optica Spectrum Disorder Participants Receiving Inebilizumab Treatment (S32.005)

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Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Protocol for a Randomized Controlled Trial

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Efficacy and safety of inebilizumab in Asian participants with neuromyelitis optica spectrum disorder: Subgroup analyses of the N-MOmentum study.

2023-08-206 citations

Serum neurofilament light chain levels at attack predict post-attack disability worsening and are mitigated by inebilizumab: analysis of four potential biomarkers in neuromyelitis optica spectrum disorder

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Association of B cell Subsets and Aquaporin-4 antibody titers with Disease Activity in Participants in the N-MOmentum trial Receiving Inebilizumab Treatment (S5.005)

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Inebilizumab Reduces Attack Risk Independent of Low Affinity IgG Fc Region Receptor III-A Gene Polymorphisms in Neuromyelitis Optica Spectrum Disorder (P13-5.015)

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Safety and Efficacy of Inebilizumab in AQP4+ NMOSD Participants with History of Immunosuppression Treatment Prior to N-MOmentum Study (P13-5.003)

Neurology2023-04-25

Safety and efficacy of inebilizumab in AQP4+ NMOSD participants with history of immunosuppression treatment prior to N-MOmentum study

2023-01-01

Association between B-cell depletion and attack risk in neuromyelitis optica spectrum disorder: An exploratory analysis from N-MOmentum, a double-blind, randomised, placebo-controlled, multicentre phase 2/3 trial.

2022-11-1025 citations

Inebilizumab for treatment of neuromyelitis optica spectrum disorder in patients with prior rituximab use from the N-MOmentum Study

Multiple Sclerosis and Related Disorders2021-10-2748 citations

Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder

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Sensitivity analysis of the primary endpoint from the N-MOmentum study of inebilizumab in NMOSD

Multiple Sclerosis Journal2021-02-0416 citations

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