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New treatment option for Chronic Inflammatory Demyelinating Polyneuropathy
Official title A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
ClinicalTrials.gov ID: NCT06752356
What this study is testing
What is Immune globulin (human) 10% solution for intravenous administration?
Immune globulin (human) 10% solution for intravenous administration is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for chronic inflammatory demyelinating polyneuropathy.
Also referred to as KIg10.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female, aged ≥18 years.
- Written informed consent and authorization to access personal health information obtained independently from participants indicating that they...
- 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...
- Participants are currently dependent on treatment with immunoglobulins, corticosteroids, or standard of care treatments for CIDP.
You likely can't join 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...
- 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...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- Absolute neutrophil count (ANC) \<1000 cells/µL.
- Clinically significant anemia or hemoglobin (Hgb) level of \< 10.0 g/dL at screening.
- Ongoing/active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV Type 1/2 infection. Participants with chronic hepatitis B or hepatitis C infection currently on treatment may participate if they...
- people who have received:
- Within 2 months before wash-out phase:
- change in treatment of methotrexate, azathioprine, or mycophenolate
- Within 3 months before wash-out phase: Efgartigimod alfa (Vyvgart)
- Within 5 months before wash-out phase: cyclophosphamide, interferon, tumor necrosis factor-alpha inhibitors, fingolimod, or any other immunosuppressive medications
- Within 12 months before wash-out phase: rituximab or alemtuzumab
- Participants who have received a hematopoietic stem cell transplant.
- Participants on corticosteroids for the treatment of CIDP after being fully washed out. Participants on maintenance doses of corticosteroid may be allowed, if treatment is for conditions unrelated to CIDP (doses usually...
- Any disorder or condition that in the investigator's judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the study.
- Participation in another clinical study involving an investigational medicinal product (IMP) or investigational device within 30 days prior to screening visit or within 5 half-lives of the IMP under investigation or is...
- History of acquired or inherited thrombophilic disorders. These will include the specific types of acquired or inherited thrombophilic disorders that could put participants at risk of developing thrombotic events...
- Hereditary thrombophilia, examples include
- Factor V Leiden mutation.
- Prothrombin 20210A mutation.
- Protein C deficiency.
- Protein S deficiency.
- Antithrombin deficiency.
- Acquired thrombophilias, examples include:
- Antiphospholipid antibody syndrome.
- Activated protein C Resistance acquired.
- Homocysteinemia.
- Previous participation in this clinical study, except for participants who withdrew consent during the washout phase, prior to randomization.
- Any other factor that, in the opinion of the investigator, would prevent the subject from complying with the requirements of the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Lebanon, New Hampshire, United States
- El Paso, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Lebanon, New Hampshire, United States; El Paso, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.