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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Stiff Person Syndrome

In brief

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).

Key facts

Study ID

NCT07552987

Run by

Kedrion S.p.A.

People needed

38

Starts

2026-09-01

Expected to finish

2028-07-01

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18-70 years of age.
• Patient has signed the Informed Consent Form (ICF).
• Diagnosed with SPS per the following criteria:
• a. Clinical symptoms (must have 1 of 2) i. Stiffness (axial regions, limbs, or both) ii. Episodic spasms (axial regions, limbs, or both) triggered by noises, tactile stimuli, emotional stress.
• b. Clinical signs during symptomatic phase of illness (must have 1 of 3) i. Increased muscle tone (axial or limbs) ii. Exaggerated lumbar lordosis iii. Concurrent stiffness of lumbar paraspinal and abdominal muscles. c. Serological findings (must have 1 of 2), based on participant medical history: i. High-titer GAD65-IgG in the serum (e.g. ≥ 20 nmol/L by radio-immunoprecipitation assay or 10,000 IU/mL by enzyme-linked immunoassay [ELISA]) or any positive titer in cerebrospinal fluid [CSF] ii. Glycine-R-IgG in serum and/or CSF by live cell binding assay.
• Patients must have paravertebral stiffness and torso/lower extremity predominance.
• 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.
• Patients who have received rituximab in the past 18 months must have B-cell reconstitution test results available from within 3 months prior to enrolment that confirms restoration of humoral immunity.
• Daily symptomatic therapy has been stable for a minimum of two weeks prior to screening and is expected to remain stable throughout the duration of the study.
• Willing to comply with all requirements of the protocol, including travel to site for scheduled protocol assessments and treatment, and completion of a diary for the study duration.
• For women of childbearing potential (WOCBP), a negative urine pregnancy test at screening, on enrollment (Day 0), and agreement to employ effective birth control measures during the study until the end of study (EOS) visit.
• Authorization to access personal health information.

You may not qualify if…

• Patients incapable of giving informed consent.
• Patients with SPS-plus or 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
• Rituximab within 6 months
• Steroid-sparing immunosuppressants (azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil) within 1 month
• Plasmapheresis within 3 months.
• Prior chimeric antigen receptor (CAR)-T cell therapy or autologous hematopoietic stem-cell transplantation.
• Received any blood, blood product, or blood derivative within 1 month of the baseline visit.
• Had therapy with live attenuated virus vaccines within 3 months of the baseline visit.
• Use of loop diuretics within 1 week of the baseline visit.
• Patients at high-risk of thrombotic events such as deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction.
• Uncontrolled hypertension (i.e., diastolic blood pressure [BP] > 100 mmHg and/or systolic BP > 160 mmHg). If a single measure exceeds this limit, a triple repeat measurement may be performed and the average of the three measurements used.
• Congestive heart failure as per New York Heart Association III/IV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart disease, hyperviscosity.
• Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia.
• Patients with hyperproteinemia, increased serum viscosity, and/or hyponatremia.
• Severe liver or kidney disease (normal reference ranges of laboratory doing the analysis):
• Alanine aminotransferase (ALT) or aspartate amino transferase (AST) >2.5x upper limit of normal (ULN)
• Creatinine > 120 µmol/L
• Blood urea nitrogen (BUN) > 2.5x ULN.
• Signs of severe anemia: Hemoglobin of less than 7 g/dL, hemodynamically unstable due to active bleeding, and/or when evidence of end-organ ischemia secondary to severe anemia is present.

Full record on ClinicalTrials.gov

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