BridgeMD
A Phase-2b, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Activity and Safety of Inebilizumab in Anti-NMDA Receptor Encephalitis and Assess Markers of Disease
EU CTIS ID: 2023-504686-23-00
What this study is testing
The primary objective is to determine the difference in disability (as measured by the mRS scale) of patients with anti-NMDAR encephalitis 16 weeks after treatment with inebilizumab compared to treatment with placebo (in both groups in addition to standard care).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of NMDAR encephalitis, defined by a subacute onset of change in mental status consistent with autoimmune encephalitis AND a positive cell-based assay for NMDAR immunoglobulin G antibody in the cerebrospinal fluid confirmed in study-specified laboratories
- Willing to forego other immunomodulatory therapies (investigational or otherwise) for NMDAR encephalitis during the study
- mRS of ≥ 3 at the screening visit, indicating at least moderate disability
- Participant must have received at least 3 days of methylprednisolone 1000 mg IV or equivalent corticosteroid within 30 days prior to randomization (Day 1). In addition, participants must have received EITHER IVIg, at dose range between 1.2 and 2 g/kg OR Plasma exchange or plasmapheresis, with a minimum of 5 treatments
You likely can't join if
- Recurrence of previously treated NMDAR encephalitis within the last 5 years, or suspicion of symptomatic untreated NMDAR encephalitis of greater than 3 months duration at the time of screening
- Receipt of any biologic B cell-depleting therapy (e.g., rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) in the 6 months prior to screening
- Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the investigational product, interpretation of participant safety or study results, or would make participation in the study an unacceptable risk
- Receipt of any of the following within 3 months prior to randomization: Natalizumab (Tysabri (r)), Cyclosporine, Methotrexate, Mitoxantrone, Cyclophosphamide, Azathioprine, Mycophenolate mofetil
The study team makes the final eligibility decision.
Where it's taking place
- United States
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. 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 EU CTIS; the study team decides eligibility.