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NOT YET RECRUITING
NCT07552987
PHASE3

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

Sponsor: Kedrion S.p.A.

View on ClinicalTrials.gov

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).

Official title: A Phase III, Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of Intravenous Human Normal Immune Globulin (IGIV) 10% in Adult Patients With Stiff Person Syndrome

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2026-09

Completion Date

2028-07

Last Updated

2026-06-10

Healthy Volunteers

No

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