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Monoclonal Antibodies

Efgartigimod for Stiff Person Syndrome (ESPS Trial)

Phase 2
Waitlist Available
Led By Tuan H Vu, MD
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of serum (or CSF) anti-GAD antibodies regardless of titers
Age 18-80, men and women, capable of giving informed consent
Must not have
History of any type of solid organ or bone marrow transplant
Exclusionary medications: rituximab within 6 months of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to end of 13 weeks
Awards & highlights

Summary

This trial aims to see if patients with stiff person syndrome experience no worsening in stiffness and spasms while taking efgartigimod-hyaluronidase (EFD) compared to their current

Who is the study for?
This trial is for patients with stiff person syndrome. Participants should be able to visit the clinic up to 18 times and handle phone call visits. The study excludes those who don't meet specific health criteria, but details on these are not provided.
What is being tested?
The trial tests efgartigimod's effectiveness in preventing worsening of stiffness and spasms in stiff person syndrome compared to current treatments. It measures changes in symptoms, lab values, vital signs, ECGs, depression, and suicide risk.
What are the potential side effects?
Specific side effects of efgartigimod are not listed here; however, the trial will monitor any adverse events including changes in laboratory values, vital signs like blood pressure or heart rate, electrocardiogram results as well as mental health aspects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood (or CSF) tests positive for anti-GAD antibodies.
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I am between 18 and 80 years old and can make my own medical decisions.
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I experience unexplained stiffness and muscle spasms in my limbs and trunk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a solid organ or bone marrow transplant.
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I have not taken rituximab in the last 6 months.
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I have not had IVIG or PLEX treatment in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to end of 13 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to end of 13 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Distribution of Stiffness Index (DSI)
heightened sensitivity score (HSS)
Secondary study objectives
Proportion of patients with SPS who are treatment responders
The duration of time patients maintain responder status

Trial Design

1Treatment groups
Experimental Treatment
Group I: subcutaneous Efgartigimod-hyaluronidase (EFG)Experimental Treatment1 Intervention
Participants with GAD65-antibody positive SPS will be given subcutaneous Efgartigimod-hyaluronidase (EFG).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efgartigimod
2022
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor
422 Previous Clinical Trials
189,217 Total Patients Enrolled
Tuan H Vu, MDPrincipal InvestigatorUniversity of South Florida
~7 spots leftby Jun 2026
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