A long-term, open-label, low-interventional safety study of inebilizumab in the treatment of NMOSD (N-MOmentum LT)
- Conditions
- euromyelitis Optica Spectrum Disorder (NMOSD)MedDRA version: 21.1Level: PTClassification code: 10077875Term: Neuromyelitis optica spectrum disorder Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 102
Provide informed consent., Age 18 years or above, Have completed at least 2 years in the OLP of the N-MOmentum study or are newly initiating inebilizumab treatment at a participating site, Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception (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. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are not postmenopausal (per International Council for Harmonisation [ICH] M3(R2) 11.2: defined as 12 months with no menses without an alternative medical cause) A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly., 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. Because male condom and spermicide is not a highly effective contraception method, it is strongly recommended that female partners of male subjects to also use a highly effective method of contraception., 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.
Have any condition that, in the opinion of the investigator, would place the participant at unacceptable risk of complications, interfere with evaluation of inebilizumab or confound the interpretation of participant safety or study results., 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., Known history of allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis following any biologic therapy., Have a severe clinically significant infection, including active chronic infection such as hepatitis B, Have active or untreated latent tuberculosis, Have a history of progressive multifocal leukoencephalopathy (PML), Is severely immunocompromised state, Have active malignancies
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish the nadir in circulating 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. <br>To characterize B-cell counts throughout treatment with inebilizumab and after discontinuation until repletion of Ig levels.;Secondary Objective: To assess long-term safety of inebilizumab, To assess other long-term effects of inebilizumab;Primary end point(s): Change from baseline over time in serum Ig levels (total Ig and IgG, IgM, IgA, IgE), Change from baseline over time in peripheral CD20+ B-cell counts.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Change from baseline over time in hematology and clinical chemistry labs;Secondary end point(s):Incidence of serious infections, viral reactivation, progressive multifocal leukoencephalopathy (PML) and other opportunistic infections, malignancies, and infusion reactions including anaphylaxis and other serious hypersensitivity reactions.;Secondary end point(s):Number and percentage of NMOSD attacks;Secondary end point(s):The incidence of ADA status and titers