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

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2011-003448-28-GB
• Date of registration: 29/03/2012
• Prospective Registration: Yes
• Primary sponsor: CSL Behring GmbH
• Public title: Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)
• Scientific title: 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
• Date of first enrolment: 23/05/2012
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003448-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Trial Disclosure Manager
• Affiliation: CSL Behring GmbH

• Name: Trial Disclosure Manager
• Affiliation: CSL Behring GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
1. Definite or probable CIDP according to the EFNS/PNS criteria 2010.
2. An IVIG treatment during the last 8 weeks prior to enrollment.
3. Age =18 years.
4. Male or female.
5. Written informed consent for study participation obtained before undergoing any study specific 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 18.1 Level: PT Classification code 10061811 Term: Demyelinating polyneuropathy System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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 code: IgPro10-SOL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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 the safety and efficacy of IgPro10 re-stabilization therapy.
- To investigate the safety and efficacy of IgPro10 rescue therapy.

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.

Timepoint(s) of evaluation of this end point: During SC treatment period - 24 weeks

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.

Secondary Outcome(s)

Secondary end point(s): • Changes in means during the SC Treatment Period for:
- INCAT score.
- Maximum grip strength score.
- Medical Research Council (MRC) sum score.
- Rasch-built Overall Disability Scale (R-ODS).
• Time to CIDP relapse or withdrawal due to any other reason.
• Time to improvement after CIDP relapse in the SC Treatment Period defined as a decrease in INCAT score back to or below the baseline score.
• Time to improvement after CIDP relapse during IgPro10 rescue therapy, defined as a decrease in INCAT score back to or below the baseline score.
• Changes in means during IgPro10 re-stabilization or rescue therapy in:
- Mean grip strength.
- MRC sum score.
- R-ODS.
- INCAT score.
• Time to improvement on IgPro10 re-stabilization therapy (INCAT score decrease, R-ODS improvement, Mean grip strength improvement).
Safety:
• Rate of AEs per SC infusion, number and percentage of subjects with AEs during the SC Treatment Period
• Rate of AEs per IgPro10 infusion, number and percentage of subjects with AEs during IgPro10 Restabilization Period or Rescue Therapy.

Timepoint(s) of evaluation of this end point: During study - up to 52 weeks

Secondary ID(s)

IgPro20_3003

2011-003448-28-DE

Source(s) of Monetary Support

CSL Behring GmbH

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 14/10/2017
• Date Completed: 20/09/2016
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-003448-28/results