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Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

NCT05684692 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-23

No results posted yet for this study

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

Conditions

  • Schwannomatosis
  • Schwannomas
  • Pain, Chronic

Interventions

DRUG

Siltuximab

A chimeric immunoglobulin G mAb, via intravenous infusion.

DRUG

Erenumab-Aooe

Human monoclonal antibody, single-dose prefilled SureClick® autoinjector, via subcutaneous injection.

DRUG

Siltuximab Matching Placebo

Dextrose 5% in water, via intravenous infusion.

DRUG

Erenumab-Aooe Matching Placebo

0.9% saline, 1 mL single-dose prefilled syringe, via subcutaneous injection.

Sponsors & Collaborators

Principal Investigators

  • Scott Plotkin, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2026-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05684692 on ClinicalTrials.gov