Massachusetts General Hospital
This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN). This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies: * Investigational Drug Sub-Study A: Siltuximab * Investigation Drug Sub-Study B: Erenumab-Aooe
This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN). The MASTER STUDY has no study drug or intervention. It is intended to enroll participants who will be placed into different treatment arms (SUB-STUDIES), which will each have an additional consent and enrollment process. MASTER STUDY * The research study procedures include screening for eligibility, randomization to an exp…
Inclusion Criteria for Master Study: * Patients must have a confirmed diagnosis schwannomatosis by fulfilling either clinical or molecular diagnosis. * Clinical diagnosis: A clinical diagnosis of schwannomatosis is confirmed by either of the two following criteria: * Two or more non-intradermal schwannomas, one with pathological confirmation, without evidence of bilateral vestibular schwannoma (see exclusion criteria 3.2.3) OR * one pathologically confirmed schwannoma or intracranial meningioma and * An affected first-degree relative. Molecular diagnosis * A molecular diagnosis of schw…
A chimeric immunoglobulin G mAb, via intravenous infusion.
Human monoclonal antibody, single-dose prefilled SureClick® autoinjector, via subcutaneous injection.
Dextrose 5% in water, via intravenous infusion.
0.9% saline, 1 mL single-dose prefilled syringe, via subcutaneous injection.
Arctuva estimate
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