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Monoclonal Antibodies

Erenumab + Siltuximab for Schwannomatosis Pain

Phase 2

Recruiting

Led By Scott Plotkin, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a confirmed diagnosis schwannomatosis by fulfilling either clinical or molecular diagnosis.

Two or more non-intradermal schwannomas, one with pathological confirmation, without evidence of bilateral vestibular schwannoma (see

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization/1st treatment to 4 weeks post final treatment

Summary

This trial is testing two drugs, Siltuximab and Erenumab-Aooe, to see if they can help people with severe pain from schwannomatosis. Siltuximab blocks tumor growth signals, and Erenumab-Aooe blocks pain signals. The trial aims to find out if these drugs can make a difference for people whose pain is hard to treat. Erenumab has been shown to be safe and effective for chronic migraine treatment.

Who is the study for?

This trial is for people with schwannomatosis, a condition causing chronic pain due to tumors on nerves. Participants must have at least two non-skin surface tumors, one confirmed by pathology, and no signs of certain other nerve-related tumors.

What is being tested?

The STARFISH trial is testing the safety and pain relief effectiveness of Erenumab-Aooe and Siltuximab against placebos in individuals with schwannomatosis. It's a phase II study where patients are randomly assigned to receive either an experimental therapy or a placebo.

What are the potential side effects?

Possible side effects from Erenumab-Aooe may include injection site reactions, constipation, muscle spasms, and possibly others. Siltuximab could cause rash, upper respiratory infections, swelling in limbs or face among other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with schwannomatosis.

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I have two or more schwannomas, one confirmed by a doctor, and no bilateral vestibular schwannoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization/1st treatment to 4 weeks post final treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization/1st treatment to 4 weeks post final treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization/1st treatment to 4 weeks post final treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in worst pain intensity for each drug sub-study

Secondary study objectives

Number of Participants with Adverse Events in each drug sub-study

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sub-study B: Erenumab-AooeExperimental Treatment2 Interventions

The treatment period includes a single-blind treatment period (days 1-84) and an open-label treatment period (days 85-168). All participants will receive erenumab-aooe during this drug sub-study. Twenty (20) participants will receive a randomization assignment to receive either Erenumab-Aooe or matching placebo during the single-blind treatment period. All participants will receive erenumab-aooe during the open-label treatment period. Participants will complete study procedures as outlined: * Single-Blind treatment period (days 1 - 84): Administration of Erenumab-Aooe versus matching placebo in pre-determined dose once every 28 days (for 3 cycles). * Open-Label Treatment period (days 85-168): Administration of Erenumab-Aooe in pre-determined dose once every 28 days (for 3 cycles).

Group II: Sub-study A: SiltuximabExperimental Treatment2 Interventions

The treatment period includes a double-blind treatment period (days 1-84) and an open-label treatment period (days 85-168). All participants will receive siltuximab during this drug sub-study. Twenty (20) participants will be randomized to receive either Siltuximab or matching placebo during the double-blind treatment period. All participants will receive siltuximab during the open-label treatment period. Participants will complete study procedures as outlined: * Double-Blind Treatment period: Administration of Siltuximab versus matching placebo in pre-determined dose once every 21 days (for 4 cycles). * Open-Label Treatment period: Administration of Siltuximab in pre-determined dose once every 21 days (for 4 cycles).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Siltuximab

2011

Completed Phase 3

~1190

0 / 2Eligibility criteria met