Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)

Randomized, multicenter, 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) – the PATH study - PATH

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003448-28-DE

Enrollment

350

Registered

2012-01-31

Start date

2012-04-20

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0 Level: PT Classification code 10061811 Term: Demyelinating polyneuropathy System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 Pharmaceutical Form: Solution for injection INN or Proposed INN: Human normal immunoglobulin (SCIg) CAS Number: 0 Current Sponsor co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Definite or probable CIDP according to the EFNS/PNS criteria 2010. 2. Repeated treatment with IVIG (= 4 doses) within the last 9 months prior to enrollment. 3. An IVIG treatment during the last 8 weeks prior to enrollment. 4. Age =18 years. 5. Male or female. 6. Written informed consent for study participation obtained before undergoing any studyspecific procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 310 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1. Any polyneuropathy of other causes 2. Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments 3. Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study 4. History of thrombotic episodes within the 2 years prior to enrolment 5. Known allergic or other severe reactions to blood products including intolerability to previous IVIG

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the efficacy of 2 different doses of IgPro20 (0.2 g/kg bw and/or 0.4 g/kg bw) in the maintenance treatment of CIDP in comparison to placebo.;Secondary Objective: - To investigate the efficacy of IgPro20 with additional clinical outcome measures in comparison to placebo. - To investigate the safety and tolerability of IgPro20 in comparison to placebo. - To investigate health-related quality of life (HRQL) following treatment with IgPro20. - To investigate the safety and efficacy of IgPro10 re-stabilization therapy. - To investigate the safety and efficacy of IgPro10 rescue therapy.;Primary end point(s): Efficacy: Percentage (%) of subjects who have a CIDP relapse during SC treatment or are withdrawn from the study during SC treatment for any reason.;Timepoint(s) of evaluation of this end point: During SC treatment period - 24 weeks	—

Measure

Time frame

Main Objective: To determine the efficacy of 2 different doses of IgPro20 (0.2 g/kg bw and/or 0.4 g/kg bw) in the maintenance treatment of CIDP in comparison to placebo.;Secondary Objective: - To investigate the efficacy of IgPro20 with additional clinical outcome measures in comparison to placebo. - To investigate the safety and tolerability of IgPro20 in comparison to placebo. - To investigate health-related quality of life (HRQL) following treatment with IgPro20. - To investigate the safety and efficacy of IgPro10 re-stabilization therapy. - To investigate the safety and efficacy of IgPro10 rescue therapy.;Primary end point(s): Efficacy: Percentage (%) of subjects who have a CIDP relapse during SC treatment or are withdrawn from the study during SC treatment for any reason.;Timepoint(s) of evaluation of this end point: During SC treatment period - 24 weeks

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy: • Changes in means at SC Treatment Period completion visit compared to baseline between groups in: - INCAT score. - Mean grip strength (dominant/non-dominant hand). - MRC sum score. - R-ODS. • Difference in “time to CIDP relapse or withdrawal due to any other reason” using a Kaplan-Meier estimation comparing both IgPro20 groups with placebo as well as the 2 IgPro20 groups pairwise. • Time to improvement on IgPro10 re-stabilization therapy (INCAT, R-ODS, Grip strength). • Changes in means before and at the end of IgPro10 re-stabilization or rescue therapy in - Mean grip strength (dominant/non-dominant hand). - MRC sum score. - R-ODS. - INCAT disability score. • Time to improvement after CIDP relapse in the SC Treatment Period and IgPro10 rescue therapy, defined as a decrease in INCAT score back to or below baseline. Safety: • For IgPro20: Rate of AEs per infusion, number and % of subjects with AEs during the SC Treatment Period • For IgPro10: rate of AEs per infusion, number and % of subjects with AEs during IVIG Restabilization Period and during IVIG rescue therapy.;Timepoint(s) of evaluation of this end point: During study - up to 52 weeks	—

Measure

Time frame

Secondary end point(s): Efficacy: • Changes in means at SC Treatment Period completion visit compared to baseline between groups in: - INCAT score. - Mean grip strength (dominant/non-dominant hand). - MRC sum score. - R-ODS. • Difference in “time to CIDP relapse or withdrawal due to any other reason” using a Kaplan-Meier estimation comparing both IgPro20 groups with placebo as well as the 2 IgPro20 groups pairwise. • Time to improvement on IgPro10 re-stabilization therapy (INCAT, R-ODS, Grip strength). • Changes in means before and at the end of IgPro10 re-stabilization or rescue therapy in - Mean grip strength (dominant/non-dominant hand). - MRC sum score. - R-ODS. - INCAT disability score. • Time to improvement after CIDP relapse in the SC Treatment Period and IgPro10 rescue therapy, defined as a decrease in INCAT score back to or below baseline. Safety: • For IgPro20: Rate of AEs per infusion, number and % of subjects with AEs during the SC Treatment Period • For IgPro10: rate of AEs per infusion, number and % of subjects with AEs during IVIG Restabilization Period and during IVIG rescue therapy.;Timepoint(s) of evaluation of this end point: During study - up to 52 weeks

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Countries

Australia, Austria, Belgium, Canada, Czech Republic, Estonia, Finland, France, Germany, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

Public ContactTrial Disclosure Manager

CSL Behring GmbH

clinicaltrials@cslbehring.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 12, 2026