NCT06752356

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

A Double-blind, Randomized, Multi-Center Study Investigating Efficacy and Safety of Two Different Dosages of Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (estimated)
• Sponsor: Kedrion S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Double Blind, Randomized study. All subjects will enter a wash-out phase of up to 12 weeks, or until functional deterioration, defined as an increase of ≥1 point (worsening) in the adjusted INCAT disability score, is demonstrated. Eligible subjects will then be randomized in a 1:2 ratio to receive either 0.5 g/kg or 1.0 g/kg KIg10 at 3-weekly intervals for 21 weeks. Subjects who relapse during randomized treatment due to functional deterioration, based on the INCAT score, will be rescued with 2.0 g/kg KIg10 at 3-weekly intervals for 21 weeks.

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

Type	Name	Description
BIOLOGICAL	Immune globulin (human) 10% solution for intravenous administration	Kedrion intravenous immunoglobulin (IVIg) 10%

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-20
• Completion: 2027-12-27
• First posted: 2024-12-30
• Last updated: 2026-04-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study