Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

Summary

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

Timeline

Start

2023-08-31

Primary completion

2026-11-30

Completion

2027-11-30

Publications

• Yin Z, Wu L, Zhang Y, Sun Y, Chen JW, Subudhi S, Ho W, Lee GY, Wang A, Gao X, Ren J, Zhu C, Zhang N, Ferraro GB, Muzikansky A, Zhang L, Stemmer-Rachamimov A, Mao J, Plotkin SR, Xu L. Co-Targeting IL-6 and EGFR signaling for the treatment of schwannomatosis and associated pain. bioRxiv [Preprint]. 2023 Feb 6:2023.02.06.527377. doi: 10.1101/2023.02.06.527377.

Drugs

Indications