Clinical trial NCT06180278: Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)
Official title: A Long-term, Open-label, Low-interventional Safety Study of Inebilizumab in the Treatment of NMOSD (N-MOmentum LT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Neuromyelitis Optica Spectrum Disorder
Keywords: Immunoglobulins
B-cell count
inebilizumab
Uplizna
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-12-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: This study aims to enroll 30 participants who either participated in the open-label period (OLP) of the N-MOmentum study (CD-IA-MEDI-551-1155; NCT02200770), a global registrational study that determined the safety and efficacy of inebilizumab for treatment of NMOSD, or who are newly initiating inebilizumab treatment at the discretion of their physician at participating sites.

Acquired from Horizon in 2024.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or above, and able to provide written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \[HIPAA\] in the United States of America (USA), European Union \[EU\] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
2. Have completed at least 2 years in the open-label period of the N-MOmentum study or are newly initiating inebilizumab treatment at a participating site.
3. Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception as outlined in the protocol (subjects in the Czech Republic only must use 1 additional method of contraception) from screening, and must agree to continue using such precautions for 6 months after treatment with inebilizumab; cessation of contraception after this point should be discussed with a responsible physician.
4. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide (subjects in the Czech Republic only must use 1 additional method of contraception) from Day 1 for 3 months after receipt of last treatment with inebilizumab.
5. Sterilized males, without the appropriate post-vasectomy documentation on the absence of sperm in the ejaculate, who are sexually active with a female partner of childbearing potential must use a condom and spermicide from Day 1 for 3 months after receipt of the last treatment with inebilizumab.

Exclusion Criteria:

1. Have any condition that would place the participant at unacceptable risk of complications, interfere with evaluation of inebilizumab or confound the interpretation of participant safety or study results.
2. Received rituximab or any other B-cell depleting agent after exit from N-MOmentum study, or within the last 12 months prior to screening for non N-MOmentum participants.
3. Known history of allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis following any biologic therapy
4. Have a severe clinically significant infection, including active chronic infection such as hepatitis B
5. Have active or untreated latent tuberculosis
6. Have a history of progressive multifocal leukoencephalopathy (PML)
7. Is severely immunocompromised state
8. Have active malignancies

Primary outcomes:
measure: Change from baseline in serum Ig levels (total Ig, IgG, IgM, IgA, IgE) over time
timeFrame: Up to 42 months
measure: Change from baseline in peripheral CD20+ B-cell counts over time
timeFrame: Up to 42 months
Secondary outcomes:
measure: Change from baseline in hematology over time
timeFrame: Up to 42 months
measure: Change from baseline in clinical chemistry over time
timeFrame: Up to 42 months
measure: Incidence of serious infections
timeFrame: Up to 42 months
measure: Incidence of viral reactivation
timeFrame: Up to 42 months
measure: Incidence of progressive multifocal leukoencephalopathy (PML)
timeFrame: Up to 42 months
measure: Incidence of other opportunistic infections
timeFrame: Up to 42 months
measure: Incidence of malignancies
timeFrame: Up to 42 months
measure: Incidence of infusion reactions
timeFrame: Up to 42 months
measure: Number of protocol-defined NMOSD attacks
timeFrame: Up to 42 months
measure: Percentage of protocol-defined NMOSD attacks
timeFrame: Up to 42 months
measure: Incidence of Anti-drug antibody (ADA) directed against Inebilizumab status and titers
timeFrame: Up to 42 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University School of Medicine
state: Michigan
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze - Neurologicka klinika
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Ophtalmology
city: Szeged
country: Hungary
facility: Szegedi TudomÃ¡nyegyetem, Ã OK, Szent-GyÃ¶rgyi Albert Klinikai KÃ¶zpont - NeurolÃ³giai OsztÃ¡ly
state: Csongrád
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center - Neurology Clinic
state: Gyeonggido [Kyonggi-do]
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - Pediatric Neurology
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Warszawa
country: Poland
facility: Uniwersyteckie Centrum Kliniczne WUM - Oddzial Kliniczny Neurologii
state: Mazowieckie
city: Katowice
country: Poland
facility: M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
state: Slaskie
city: Khon Kaen
country: Thailand
facility: Khon Kaen University, Srinagarind Hospital - Division of Neurology, Depart
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: