A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subje… (NCT06752356) | Clinical Trial Compass
RecruitingPhase 3
A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
United States161 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 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, 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.
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.
What they're measuring
1
Efficacy of 1.0 g/kg KIg10 in the treatment of adult subjects with active CIDP
Timeframe: From Baseline upto 24 weeks of treatment
. Participants should be clinically stable 12 weeks prior to screening date as defined by:
Exclusion criteria
. 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).