Stiff Person SyndromePhase 3NCT07552987
A Study Investigating Intravenous Human Normal Immune Globulin 10% in Adults With Stiff Person Syndrome
A Phase 3 study testing Kedrion IVIg 10% and Human Albumin in people with Stiff Person Syndrome, run by Kedrion S.p.A..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stiff Person Syndrome
- What is being tested?
- Kedrion IVIg 10% and Human Albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18-70 years of age.
- Patient has signed the Informed Consent Form (ICF).
- Diagnosed with SPS per the following criteria:
- 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.
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Body mass index > 35 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload.
- History of a malignant disease within 3 years of the baseline visit other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin.
- Patients having participated in an interventional, investigational clinical study within 30 days of the baseline visit, or within 5 half-lives of the investigational medicinal product (IMP) under investigation.
- Any condition that the Investigator believes is likely to interfere with evaluation of the IMP or with satisfactory conduct of the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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).
Read the detailed description
This is a phase III, double-blind, placebo-controlled, parallel group, multicenter study to assess the efficacy and safety of QIVIGY in adult participants with stiff person syndrome.
Participants will be randomized in a 1:1 ratio, to receive either 2 g/kg of QIVIGY or equivalent volume of placebo. During the randomized phase, study treatment will be administered every 4 weeks for 24 weeks, at which point the primary efficacy endpoint assessment will be performed at an End of Randomized Treatment visit.
At this study visit, all participants will be given the option to enter an open-label study extension. Participants who choose to continue in the study will receive 2.0 g/kg QIVIGY every 4 weeks, for a duration of 24 weeks.
- Conditions
- Stiff Person Syndrome
- Being tested
- Kedrion IVIg 10%, Human Albumin
- Keywords
- Stiff Person Syndrome, SPS, Neurological Disorders, Autoimmune Disease, Human Immunoglobulin
- Medical subject headings
- Stiff-Person Syndrome, Nervous System Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kedrion IVIg 10%Biological
Also called QIVIGY, KIg10
Intravenous human normal immunoglobulin (IVIg) 10%
Human AlbuminBiological
Human albumin solution, diluted with saline 0.9% to a final concentration of 0.5% as an intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Kedrion IVIg 10% | Experimental | Participants will receive 2 g/kg IVIg 10% administered over 2-5 days at 4-week intervals for 24 weeks. Participants will have the option to enter the open label extension phase and receive IVIg 10% for 24 weeks to week 48. Receives: Biological: Kedrion IVIg 10% |
| Placebo | Placebo comparator | Participants will receive equivalent volume of placebo administered over 2-5 days at 4-week intervals for 24 weeks. Participants will have the option to enter the open label extension phase and receive IVIg 10% for 24 weeks to week 48. Receives: Biological: Human Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed 25-Foot Walk (T25-FW)
Proportion of participants showing an improvement on the Timed 25-Foot Walk
Measured: Baseline to Week 24
Secondary outcomes (10)
Timed 25-Foot Walk (T25-FW)
Change in the Timed 25-Foot Walk from baseline to Week 24 and, for participants entering the study extension, to Week 48
Measured: Baseline up to Week 48
Distribution-of-Stiffness (DSI)
Change in the scores of the distribution-of-stiffness index (DSI) from baseline to Week 24 and, for participants entering the study extension, to Week 48
Measured: Baseline up to Week 48
Heightened Sensitivity Scale (HSS)
Change in heightened sensitivity scale (HSS) from baseline to Week 24 and, for participants entering the study extension, to Week 48
Measured: Baseline up to Week 48
Modified Rankin Scale (mRS)
Change in Modified Rankin scale (mRS) from baseline to Week 24 and, for participants entering the study extension, to Week 48
Measured: Baseline up to Week 48
HRQoL assessments (Neuro-QOL)
Change in score by visit
Measured: Baseline up to Week 48
Pain Interference Score
Change in score by visit
Measured: Baseline up to Week 48
Change in level of walking aid dependency
Change from baseline in level of walking aid dependency will be assessed by clinician-reported ambulatory status during scheduled clinical outcome assessments. Walking aid use (unaided, cane, or walker) will be recorded at baseline and at each study visit. Improvement is defined as a reduction in level of assistance (e.g., from walker to cane or unaided, or from cane to unaided).
Measured: Baseline up to Week 48
Assess Safety
Assess treatment-emergent AEs and SAEs
Measured: Day 0 to Week 48
Duration of Response
Participants on QIVIGY in the randomized phase who responded to treatment will be assessed for continued change (duration of response) through 12 months, based on the T25-FW Test
Measured: Week 24 to Week 48
Time to response
Participants on placebo in the randomized phase and did not achieve a response will be assessed for time to response to QIVIGY based on the T25-FW Test
Measured: Week 24 to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stiff Person SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kedrion S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miranda Norton, PhD, Study chair, Kedrion S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552987
- Sponsor's protocol ID
- KB075
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Publishing of data and IPD that underlie results in the publication will be determined at study completion to comply with ICMJE minimum requirements.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07552987
- Acronym / sponsor ID
- KB075
- Conditions
- Stiff Person Syndrome
- Keywords
- Stiff Person Syndrome, SPS, Neurological Disorders, Autoimmune Disease, Human Immunoglobulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Kedrion S.p.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a phase III, double-blind, placebo-controlled, parallel group, multicenter study to assess the efficacy and safety of QIVIGY in adult participants with stiff person syndrome.
Participants will be randomized in a 1:1 ratio, to receive either 2 g/kg of QIVIGY or equivalent volume of placebo. During the randomized phase, study treatment will be administered every 4 weeks for 24 weeks, at which point the primary efficacy endpoint assessment will be performed at an End of Randomized Treatment visit.
At this study visit, all participants will be given the option to enter an open-label study extension. Participants who choose to continue in the study will receive 2.0 g/kg QIVIGY every 4 weeks, for a duration of 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kedrion IVIg 10% | Experimental | Biological: Kedrion IVIg 10%Participants will receive 2 g/kg IVIg 10% administered over 2-5 days at 4-week intervals for 24 weeks. Participants will have the option to enter the open label extension phase and receive IVIg 10% for 24 weeks to week 48. |
| Placebo | Placebo comparator | Biological: Human AlbuminParticipants will receive equivalent volume of placebo administered over 2-5 days at 4-week intervals for 24 weeks. Participants will have the option to enter the open label extension phase and receive IVIg 10% for 24 weeks to week 48. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (29 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kedrion IVIg 10%Also: QIVIGY, KIg10Intravenous human normal immunoglobulin (IVIg) 10% | Biological | Kedrion IVIg 10% |
| Human AlbuminHuman albumin solution, diluted with saline 0.9% to a final concentration of 0.5% as an intravenous infusion | Biological | Placebo |
Primary outcome
Timed 25-Foot Walk (T25-FW)
Time frame: Baseline to Week 24
Proportion of participants showing an improvement on the Timed 25-Foot Walk
10 secondary outcomes
Timed 25-Foot Walk (T25-FW)
Time frame: Baseline up to Week 48
Distribution-of-Stiffness (DSI)
Time frame: Baseline up to Week 48
Heightened Sensitivity Scale (HSS)
Time frame: Baseline up to Week 48
Modified Rankin Scale (mRS)
Time frame: Baseline up to Week 48
HRQoL assessments (Neuro-QOL)
Time frame: Baseline up to Week 48
Pain Interference Score
Time frame: Baseline up to Week 48
Change in level of walking aid dependency
Time frame: Baseline up to Week 48
Assess Safety
Time frame: Day 0 to Week 48
Duration of Response
Time frame: Week 24 to Week 48
Time to response
Time frame: Week 24 to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. Publishing of data and IPD that underlie results in the publication will be determined at study completion to comply with ICMJE minimum requirements.
Related trials for Stiff Person Syndrome
Not yet recruitingPhase 1/2
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Refractory Neurologic Autoimmune Disease
Progressive Multiple Sclerosis (PMS), Neuromyelitis Optica
RecruitingPhase 2/3
VYVGART (Hytrulo) in Patients With Stiff Person Syndrome (SPS)
Stiff Person Syndrome
RecruitingObservational study
Biomarkers in Autoimmune Disease of Nervous System
Autoimmune Diseases of the Nervous System, Neuromyelitis Optica Spectrum Disorder
Enrolling by invitationPhase 1
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease
Lupus Nephritis, Autoimmune Diseases
Active, not recruitingPhase 2
Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases
Autoimmune Disease, Neurologic Autoimmune Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miranda Norton, PhD study chair
Kedrion S.p.A.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Kedrion IVIg 10% and Human Albumin in people with Stiff Person Syndrome, run by Kedrion S.p.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Conz (+39 331 6267651, c.conz@kedrion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed 25-Foot Walk (T25-FW) (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.