Phase 3 IV Immune Globulin Trial for Stiff Person Syndrome
ClinicalTrials.gov Studies
Summary
A Phase 3 clinical trial (NCT07552987) is investigating QIVIGY (Intravenous Human Normal Immune Globulin 10%) versus placebo in adults with stiff person syndrome (SPS). The study, sponsored by Kedrion, will evaluate both efficacy and safety of the IVIg 10% intervention against a human albumin 5% comparator. Participants enrolled in this trial will be monitored for treatment response in this rare autoimmune neurological condition.
“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).”
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What changed
This document registers a new Phase 3 clinical trial on ClinicalTrials.gov for QIVIGY (Intravenous Human Normal Immune Globulin 10%) in adults with stiff person syndrome. The randomized, placebo-controlled study will assess both efficacy and safety endpoints. Key interventions include Kedrion IVIg 10% compared against a human albumin 5% control arm.
For pharmaceutical sponsors and clinical investigators considering rare neurological disease research, this trial registration signals active industry investment in SPS therapeutics. Contract research organizations and institutional review boards may encounter related protocol submissions. The trial's placebo-controlled design is notable given the absence of approved treatments for this rare autoimmune condition.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study Investigating Intravenous Human Normal Immune Globulin 10% in Adults With Stiff Person Syndrome
Phase 3 NCT07552987 Kind: PHASE3 Apr 27, 2026
Abstract
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: Kedrion IVIg 10%, Human Albumin 5%
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