A Study Investigating Intravenous Human Normal Immune Globulin 10% in Adults With Stiff Person Sy… (NCT07552987) | Clinical Trial Compass
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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, 18-70 years of age.
. Patient has signed the Informed Consent Form (ICF).
. Diagnosed with SPS per the following criteria:
. 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
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)