Immune Globulin for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Overseen By Esra Cinar-Jones

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kedrion S.p.A.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

161 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Miranda Norton, PhD

Principal Investigator

Kedrion S.p.A.

Are You a Good Fit for This Trial?

This trial is for individuals with a confirmed diagnosis of CIDP, who experience significant disability and limb weakness. Participants must understand the study and agree to its procedures. They should be dependent on treatments like immunoglobulins or corticosteroids without recent changes in dosage or worsening symptoms.

Inclusion Criteria

My current medication dose has been stable without needing extra treatments.

I have signed a consent form and agree to share my health information for the study.

I have been diagnosed with CIDP according to the 2021 EAN/PNS criteria.

What Are the Treatments Tested in This Trial?

Interventions

• Intravenous Human Normal Immune Globulin (IGIV) 10%

Trial Overview

The study tests two different doses of KIg10 (Intravenous Human Immune globulin 10%) as maintenance therapy for CIDP over a period of 21 weeks, aiming to evaluate its effectiveness and safety.

How Is the Trial Designed?

Group I: 1.0 g/kg dose group for 24 weeks Experimental Treatment 1 Intervention

This group will receive, initial loading dose of 2.0 g/kg of Intravenous (IV) KIg10 (Immunoglobulin) infusion followed by 1.0 g/kg of IV KIg10 every 3 weeks.

Group II: 0.5 g/kg dose group for 24 weeks Experimental Treatment 1 Intervention

This group will receive, Initial loading dose of 2.0 g/kg of Intravenous (IV) KIg10 (Immunoglobulin) infusion will be given followed by 0.5 g/kg of IV KIg10 every 3 weeks.

Who Is Running the Clinical Trial?

Kedrion S.p.A.

Lead Sponsor

Trials

8

Recruited

330+