MedTrace Logo

A Study Investigating Intravenous Human Normal Immune Globulin 10% in Adults With Stiff Person Syndrome

NCT07552987 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-06-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of QIVIGY (Intravenous Human Normal Immune Globulin 10%) compared with placebo in adult participants with stiff person syndrome (SPS).

Conditions

  • Stiff Person Syndrome

Interventions

BIOLOGICAL

Kedrion IVIg 10%

Intravenous human normal immunoglobulin (IVIg) 10%

BIOLOGICAL

Human Albumin

Human albumin solution, diluted with saline 0.9% to a final concentration of 0.5% as an intravenous infusion

Sponsors & Collaborators

  • Kedrion S.p.A.

    lead INDUSTRY

Principal Investigators

  • Miranda Norton, PhD · Kedrion S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-01-31
Completion
2028-07-31
FDA Drug
Yes

More Related Trials

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 NCT07552987 on ClinicalTrials.gov