Not Yet RecruitingPhase 3

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

38 participantsStarted 2026-09

Plain-language 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).

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Male or female, 18-70 years of age.
✓. Patient has signed the Informed Consent Form ICF).
✓. Diagnosed with classic SPS or SPS-plus per the following criteria:
✓. Distribution of stiffness index score of ≥ 2, including stiffness in the legs or trunk.
✓. Patient may be Ig-naïve or Ig-pre-treated, however they should not have received Ig within 3 months prior to the time of study entry (Day 0).
✓. Includes newly diagnosed patients
✓. Includes patients who have received symptomatic treatments only
✓. Includes patients who have failed to respond to rituximab.

Exclusion criteria

✕. Patients incapable of giving informed consent.
✕. Patients with variants of SPS such as paraneoplastic or progressive encephalomyelitis with rigidity and myoclonus (PERM). Patients with pure cerebellar ataxia, ocular motor apraxia.
✕. Patients who are bed-bound or wheelchair-dependent.
✕. Ongoing/active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV Type 1/2 infection. Subjects with chronic hepatitis B or hepatitis C infection currently on treatment may participate if they have undetectable viral load within 12 months of screening date.
✕. Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to glycine (used as an excipient).
✕. Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA.
✕. Patients who are planning to receive the following treatments within the coming 12 months, or who have received in the stated timeframe before enrollment (Day 0)
✕. Botulinum toxin within 6 months

What they're measuring

Timed 25-Foot Walk (T25-FW)

Timeframe: Baseline to Week 24

Trial details

NCT IDNCT07552987

SponsorKedrion S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Cecilia Conz

+39 331 6267651 c.conz@kedrion.com

View on ClinicalTrials.gov More Stiff Person Syndrome trials