BridgeMD
A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with NMDAR or LGI1 mediated autoimmune Encephalitis
EU CTIS ID: 2023-504226-18-00
What this study is testing
Part 1: To evaluate the efficacy of satralizumab compared with placebo on degree of disability and clinical severity, as measured by the proportion of participants with 1-point improvement in the Modified Rankin Scale (mRS) and no use of rescue therapy at Week 24 (NMDAR AIE cohort) and at week 52 (LGI1 AIE cohort) Part 2: To evaluate the long-term safety and tolerability of satralizumab
- Therapeutic confirmatory (Phase III)
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
- Reasonable exclusion of tumor or malignancy before baseline visit (randomization)
- Onset of autoimmune encephalitis (AIE) symptoms <=9 months before randomization
- Meet the definition of "New Onset" or "Incomplete Responder" AIE
- Diagnosis of probable or definite NMDAR encephalitis
- Diagnosis of LGI1 encephalitis
You likely can't join if
- Any untreated teratoma or thymoma at baseline visit (randomization)
- History of carcinoma or malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for >=5 years before screening
- For patients with NMDAR AIE, history of negative anti-NMDAR antibody in cerebrospinal fluid (CSF) using a cell-based assay within 9 months of symptom onset
- Historically known positivity to an intracellular antigen with high cancer association or GAD65
- Historically known positivity to any cell surface neuronal antibodies other than NMDAR and LGI1, in the absence of NMDAR and LGI1 antibody positivity
- Confirmed paraneoplastic encephalitis
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Argentina
- Japan
- Ghana
- Korea, Republic of
- Russian Federation
- Canada
- United States
- China
- Taiwan
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, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Argentina; Japan; Ghana; Korea, Republic of; Russian Federation and 4 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 EU CTIS; the study team decides eligibility.