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New treatment option for Neuromyelitis Optica Spectrum Disorder
Official title Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
ClinicalTrials.gov ID: NCT05549258
What this study is testing
What is Inebilizumab?
Inebilizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuromyelitis optica spectrum disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 2, open-label, multicenter study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of inebilizumab in eligible pediatric participants 2 to \< 18 years of age with recently active neuromyelitis optica spectrum disorder (NMOSD) who are seropositive for autoantibodies against aquaporin-4 (AQP4-immunoglobulin [Ig]G).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 28 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Male or female participants, minimum body weight of 15 kg, age 2 to \< 18 years at the time of screening.
- Positive serum anti-AQP4-IgG result at screening and diagnosed with NMOSD according to the criteria of Wingerchuk et al, 2015.
- Documented history of one or more NMOSD acute relapses within the last year, or 2 or more NMOSD acute relapses within 2 years prior to screening.
You likely can't join if
- Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the Investigational Product or...
- Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the...
- Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality (one repeat test may be conducted to...
- B-cell counts \< one-half of the lower limit of normal (LLN) for age according to the central laboratory.
- Receipt of the following at any time prior to Day 1:
- Alemtuzumab
See the full eligibility criteria
- Male or female participants, minimum body weight of 15 kg, age 2 to \< 18 years at the time of screening.
- Positive serum anti-AQP4-IgG result at screening and diagnosed with NMOSD according to the criteria of Wingerchuk et al, 2015.
- Documented history of one or more NMOSD acute relapses within the last year, or 2 or more NMOSD acute relapses within 2 years prior to screening.
- Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the Investigational Product or interpretation of participant safety or study results.
- Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is the longer, prior to Day 1.
- Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality (one repeat test may be conducted to confirm results within the same screening period).
- B-cell counts \< one-half of the lower limit of normal (LLN) for age according to the central laboratory.
- Receipt of the following at any time prior to Day 1:
- Alemtuzumab
- Total lymphoid irradiation
- Bone marrow transplant
- T-cell vaccination therapy
- Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior to screening unless B-cell counts have returned to ≥ one-half the LLN.
- Receipt of intravenous immunoglobulin (IVIG) within one month prior to Day 1.
- Receipt of any of the following within 2 months prior to Day 1:
- Cyclosporine
- Methotrexate
- Mitoxantrone
- Cyclophosphamide
- Tocilizumab
- Satralizumab
- Eculizumab
- Receipt of natalizumab (Tysabri®) within 6 months prior to Day 1.
- Severe drug allergic history or anaphylaxis to 2 or more food products or medicine (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, and methylprednisolone or...
- Diagnosed with a concurrent autoimmune disease that is uncontrolled (unless approved by the medical monitor).
- Recent receipt of live/attenuated vaccine or blood transfusion. Receipt of any of the following:
- Any live or attenuated vaccine within 4 weeks prior to Day 1 (administration of killed vaccines and nucleoside-modified mRNA-based vaccines is acceptable; the Sponsor recommends that Investigators ensure all...
- Bacillus Calmette Guérin vaccine within one year of screening.
- Blood transfusion within 4 weeks prior to screening or during screening.
- Clinically significant serious active or chronic viral, bacterial, or fungal infection that requires treatment with anti-infectives, hospitalization, or, in the Investigator's opinion, represents an additional risk to...
- Known history of congenital or acquired immunodeficiency (e.g., due to human immunodeficiency virus [HIV] infection, splenectomy, immunosuppression-related or idiopathic T-cell deficiencies) that predisposes the...
- Positive test for chronic hepatitis B infection at screening, defined as either: a. Positive hepatitis B surface antigen (HBsAg), or b. Positive hepatitis B core (HBc) antibody (anti-HBc) plus negative hepatitis B...
- Positive test for hepatitis C virus antibody.
- Negative test for varicella zoster virus (VZV)-IgG.
- History of cancer, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy \> 3 months prior to Day 1.
- History of active or latent tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening, unless treatment for TB was completed per local guidelines. Participants with latent TB or a positive QuantiFERON®-TB...
- For participants who may undergo MRI scans:
- Unable to undergo an MRI scan (e.g., hypersensitivity to Gd-containing MRI contrast agents, implanted pacemakers, defibrillators, or other metallic objects on or inside the body that limit performing MRI scans), or
- Unable to tolerate or comply with the MRI procedure.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Loma Linda, California, United States
- Boston, Massachusetts, United States
- Dallas, Texas, United States
- Parque Patricios, Ciudad Autónoma de BuenosAires, Argentina
- Salvador, Estado de Bahia, Brazil
- Porto Alegre/RS, Brazil
- São Paulo, Brazil
- Toronto, Ontario, Canada
- Le Kremlin-Bicêtre, Val-de-Marne, France
- Rotterdam, South Holland, Netherlands
- Gdansk, Poland
- Belgrade, Belgrade, Serbia
- Espluges de Llobregat, Barcelona, Spain
- Stockholm, Stockholm County, Sweden
- London, London, City of, United Kingdom
- Birmingham, West Midlands, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 28 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Loma Linda, California, United States; Boston, Massachusetts, United States; Dallas, Texas, United States; Parque Patricios, Ciudad Autónoma de BuenosAires, Argentina; Salvador, Estado de Bahia, Brazil and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.