A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Phase 3 Recruiting 161 enrolled Kedrion S.p.A.

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2026-06
Primary completion: 2027-12-20
Completion: 2027-12-27

Publications

Background Hughes RA, Donofrio P, Bril V, Dalakas MC, Deng C, Hanna K, Hartung HP, Latov N, Merkies IS, van Doorn PA; ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008 Feb;7(2):136-44. doi: 10.1016/S1474-4422(07)70329-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	0.5 g/kg	Intravenous
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	1 g/kg	Intravenous
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	2 g/kg	Intravenous

A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Summary

Timeline

Publications

Drugs

Indications