Recruitment Complete
Sponsor ID
HZNP-UPL-401

Long-term, open-label, safety study of inebilizumab in Neuromyelitis optica spectrum disorder (NMOSD)N-MOmentum LT

Sponsor ID
HZNP-UPL-401
Clinicaltrials.gov ID
NCT06180278
EUCTIS ID
N/A
EudraCT ID
N/A

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

Additional Study Details

Phase
Phase 4
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
32
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change from baseline in serum Ig levels (total Ig, IgG, IgM, IgA, IgE) over time

Timeframe: Up to 42 months

Change from baseline in peripheral CD20+ B-cell counts over time

Timeframe: Up to 42 months

Secondary Outcome Measures

Change from baseline in hematology over time

Timeframe: Up to 42 months

Change from baseline in clinical chemistry over time

Timeframe: Up to 42 months

Incidence of serious infections

Timeframe: Up to 42 months

Incidence of viral reactivation

Timeframe: Up to 42 months

Incidence of progressive multifocal leukoencephalopathy (PML)

Timeframe: Up to 42 months

Incidence of other opportunistic infections

Timeframe: Up to 42 months

Incidence of malignancies

Timeframe: Up to 42 months

Incidence of infusion reactions

Timeframe: Up to 42 months

Number of protocol-defined NMOSD attacks

Timeframe: Up to 42 months

Percentage of protocol-defined NMOSD attacks

Timeframe: Up to 42 months

Incidence of Anti-drug antibody (ADA) directed against Inebilizumab status and titers

Timeframe: Up to 42 months

Locations

Location
Status
Contact Us
Location
Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Ophtalmology
Hong Kong SAR, Hong Kong, 0000
Status
Recruiting
Location
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ - Neurológiai Osztály
Szeged, Csongrád, Hungary, 6725
Status
Recruiting
Location
Samsung Medical Center - Pediatric Neurology
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Republic of Korea, 06351
Status
Recruiting
Location
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Republic of Korea, 03080
Status
Recruiting
Location
National Cancer Center - Neurology Clinic
Goyang-si, Gyeonggido [Kyonggi-do], Republic of Korea, 10408
Status
Recruiting
Location
M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
Katowice, Slaskie, Poland, 40-751
Status
Recruiting
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