Chronic Inflammatory Demyelinating Polyneuropathy study: Immune globulin
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?
An investigational intravenous immunoglobulin being studied as a maintenance therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). It is designed to supply pooled human antibodies that can modulate the immune system and reduce abnormal nerve inflammation.
Also referred to as IVIG, human immune globulin, 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
- This study is testing whether two different amounts of a blood protein infusion can help keep symptoms of CIDP under control after 21 weeks of treatment.
- Who it's for
- You may be able to join if you have chronic inflammatory demyelinating polyneuropathy and have been receiving treatment for it.
- What's involved
- You will receive an intravenous infusion of the blood protein at one of two doses. You will have visits to monitor your health and any side effects.
- Time commitment
- The study lasts about 21 weeks, with regular infusion visits and health check‑ins during that time.
- 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.
- 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.
- 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.
- 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.
- 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...
- 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.
- 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...
- Hereditary thrombophilia, examples include
- Factor V Leiden mutation.
- Prothrombin 20210A mutation.
- Protein C deficiency.
- Protein S deficiency.
- Antithrombin deficiency.
- 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 is enrolling
- Stamford, Connecticut, United States
- Miami, Florida, United States
- Pembroke Pines, Florida, United States
- 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, but 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?
This study is enrolling now at Stamford, Connecticut, United States; Miami, Florida, United States; Pembroke Pines, Florida, United States; Tampa, Florida, United States; Lebanon, New Hampshire, United States; El Paso, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.