A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Recruiting now · Phase 3

Conditions studied: Chronic Inflammatory Demyelinating Polyneuropathy

In brief

The current study is being conducted to assess the efficacy and safety of KIg10 (Intravenous Human Immune globulin 10%) at two different dosages as maintenance therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) following 21 weeks of treatment.

Key facts

Study ID: NCT06752356
Run by: Kedrion S.p.A.
People needed: 161
Starts: 2026-08-01
Expected to finish: 2027-12-27
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female, aged ≥18 years.
Written informed consent and authorization to access personal health information obtained independently from participants indicating that they understand the purpose of, and procedures required for, the study and are willing to participate.
Documented diagnosis of CIDP consistent with the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria.
Current or documented history of significant disability, as defined by an overall INCAT disability score between 2 and 9. A score of 2 must be exclusively from the lower extremities.
Participants are currently dependent on treatment with immunoglobulins, corticosteroids, or standard of care treatments for CIDP.
Weakness of at least two limbs.
Participants should be clinically stable 12 weeks prior to screening date as defined by:
without a worsening in INCAT score of ≥1 point, AND/OR without significant changes in clinical symptoms AND
without significant dose changes or requiring additional treatments.

You may not qualify if…

Patients' incapable of giving informed consent.
Pure sensory and other CIDP variants.
Females who are pregnant, breastfeeding, unwilling to practice effective birth control methods as defined in Appendix C throughout the study, or planning a pregnancy during the study.
IG-experienced participants requiring an IGIV dosage of more than 1.4 g/kg/month OR SCIG pre-treated participants requiring a SCIG dosage of more than 1.6 g/kg/month.
Participants who have previously failed to respond to IGIV or SCIG.
On screening date, a body mass index (BMI) > 35 kg/m2 or an IGIV dose that puts the patient at risk of fluid overload.
CIDP and any neuropathy of other causes not consistent with the 2021 EAN/PNS criteria including:
Hereditary demyelinating neuropathies, such as a hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth [CMT] disease), and hereditary sensory and autonomic neuropathies (HSANs).
Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and non-diabetic lumbosacral radiculoplexopathy or neuropathy, lymphoma, and amyloidosis.
Multifocal motor neuropathy (MMN).
Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy. Peripheral neuropathy induced by vitamin B12 deficiency.
Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with increased titers of antibodies to myelin-associated glycoprotein.
Central demyelinating disorders (e.g, multiple sclerosis) or severe myopathy.
Any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of CIDP or outcome measures (e.g., severe arthritis, stroke, Parkinson's disease, and diabetic peripheral neuropathy) [participants with clinically diagnosed diabetes mellitus, who have adequate glycemic control with Hemoglobin A1C (HbA1C) of <7.5% at screening, and who agree to maintain adequate glycemic control during the study are allowed].
Congestive heart failure (New York Heart Association (NYHA) Class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension [i.e., diastolic blood pressure >100 mmHg and/or systolic blood pressure >160 mmHg]. If a single measure exceeds this limit, a triple repeat measurement may be performed and the average of the three measurements used.
History of deep vein thrombosis or thromboembolic events (e.g, cerebrovascular accident, pulmonary embolism) in the past 12 months.
Condition(s) which could alter protein catabolism and/or IgG utilization (e.g, protein-losing enteropathies, nephrotic syndrome).
Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60 milliliter per minute per 1.73 square meter (mL/min/1.73m2) estimated based on an established chronic kidney disease epidemiology collaboration (CKD-EPI) equation at the time of screening.
Active malignancy requiring chemotherapy and/or radiotherapy, or history of malignancy with less than 2 years of complete remission prior to screening. Exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment.
Hypersensitivity or adverse reactions (e.g, urticaria, breathing difficulty, severe hypotension, or anaphylaxis) to human blood products such as human IgG, albumin, or other blood components.
Known history of immunoglobulin A (IgA) deficiency.
Known history of autoimmune nodo-paranodopathies causing IG treatment resistance, including anti-neurofascin (NF) 186 antibodies and antibodies against paranodal proteins, such as NF155, contactin 1 (CNTN1), and contactin-associated protein 1 (CASPR1).
Abnormal laboratory values at screening:
Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN)
Platelet count <100,000 cells/µL.

Where it is running

USF Health - Morsani Center for Advanced Healthcare — Tampa, Florida, United States (enrolling)
Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
Advanced Neurology Epilepsy and Sleep Center/ANESC Research — El Paso, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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