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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Amgen
Study ID
NCT06180278
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Neuromyelitis Optica Spectrum Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood tests — OTHER
    Participants will have blood tests done at each scheduled visit (approximately every 6 months).
  • Inebilizumab — DRUG
    Participants with NMOSD who previously enrolled in N-MOmentum study, who participated for at least 2 years in the open label phase (OLP) of the study, and participants newly initiating inebilizumab treatment at the discretion of their treating physician will have hematology, chemistry, B-cell count, serum immunoglobulin (Ig) levels, adverse events, concomitant medications list, NMOSD attacks information, antidrug antibody (ADA) status and titers collected.

Study Details

The purpose of this study is to understand the effects of long-term treatment with inebilizumab on circulating levels of immunoglobulins, B-cell counts, and other safety measures, and to further monitor repletion of immunoglobins and B-cell counts in participants with NMOSD who discontinue treatment. The objectives include: 1. To establish the nadir in circulating immunoglobulins (Ig) during chronic treatment with inebilizumab and ascertain the time needed to ensure restoration of pre-treatment baseline serum levels of IgG and IgM after discontinuation of treatment 2. To characterize B-cell counts throughout treatment with inebilizumab and after discontinuation until repletion of Immunoglobulin (Ig levels) 3. To assess long-term safety of inebilizumab 4. To assess other long-term effects of inebilizumab

Key Dates

Start date
Apr 2, 2024
Status verified
Nov 2025
Primary completion
Jun 26, 2028
Completion
Jun 26, 2028

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Participants with NMOSD exposed to inebilizumab
    Participants with NMOSD who previously enrolled in N-MOmentum study, who participated for at least 2 years in the open label phase (OLP) of the study, and participants newly initiating inebilizumab treatment will have hematology, chemistry, B-cell count, serum immunoglobulin (Ig) levels, adverse events, concomitant medications list, NMOSD attacks information, antidrug antibody (ADA) status and titers collected.

Primary Outcome Measure

Change from baseline in serum Ig levels (total Ig, IgG, IgM, IgA, IgE) over time [ Time Frame: Up to 42 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Wayne State University School of MedicineDetroitMichigan48201-2153-
Baylor College of MedicineHoustonTexas77030-4202-

Find similar trials in Detroit, MI

By research site
Wayne State University School of Medicine· Detroit, MIBaylor College of Medicine· Houston, TX

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