Path study (CIDP)

Randomized, multicentre, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety and tolerability of 2 different doses of Igpro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

Background

CIDP is an acquired neurological, demyelinating neuropathy.

Due to its heterogeneous presentation, the diagnosis relies on findings from multiple modalities.

The probable autoimmune link is most strongly suggested by response to immunotherapies such as:

• intravenous immunoglobulins (IVIGs)
• plasmapheresis (PE)
• and corticosteroids

Corticosteroids are a first-line therapy because of their long history of use. But there is less definitive published evidence of their efficacy.

Several randomised clinical studies have shown the clinical efficacy and safety of IVIGs to treat CIDP.

Apart from IVIGs, there are currently no other medications approved for the treatment of CIDP. IVIGs require patients to visit a clinic or hospital for 1 to 5 days on a regular basis, usually every 2 to 6 weeks.

This study evaluates subcutaneous immunoglobulin (SCIG) as an alternative treatment option for CIDP. That would allow patient (or their caregiver) to self-administer the product at home.

IgPro20 is a ready-to-use formulation of human IgG with ³98% purity for SC administration. IgPro20 is approved in several countries (brand name Hizentraâ) for SC application in primary immune deficiency syndromes.

It is also under review by other regulatory agencies for use in primary and secondary immunodeficiencies.

Trial information

This is a prospective, multicentre, randomised, double-blind, placebo-controlled, parallel-group 3-arm study.

Primary objective

To investigate two different doses of SCIG IgPro20 compared to subcutaneous (SC) placebo for maintenance treatment of subjects with CIDP.