Phase 3 N=208 Randomized Quadruple-blind Treatment

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)

Chronic Inflammatory Demyelinating Polyneuropathy · Polyradiculoneuropathy

Bottom Line

View on ClinicalTrials.gov: NCT01545076 ↗

Enrolled (actual)

208

Serious AEs

4.3%

Results posted

Jul 2018

Primary outcome: Primary: Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period — 32.8; 38.6; 63.2 percentage of subjects — p==0.007

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: IgPro20 (low dose) (Biological); Placebo (Biological); IgPro10 (Biological); IgPro20 (high dose) (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: CSL Behring
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period	32.8; 38.6; 63.2	=0.007 sig
SECONDARY Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period	0; 0; 1	=0.005 sig
SECONDARY Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period	-2.7; -0.6; -6.6	=0.004 sig
SECONDARY Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period	0; 0; -2	=0.003 sig
SECONDARY Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period	0; -2; -3	=0.03 sig
SECONDARY Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period	NA; NA; 79.0	—
SECONDARY Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period	0.051; 0.079; 0.034	—
SECONDARY Number of Subjects With Adverse Events During the SC Treatment Period	30; 33; 21	—
SECONDARY Percentage of Subjects With Adverse Events During the SC Treatment Period	51.7; 57.9; 36.8	—
SECONDARY Time to Improvement During IgPro10 Re-stabilization Therapy	23	—
SECONDARY Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy	11.27	—
SECONDARY Change in MRC Sum Score During IgPro10 Re-stabilization Therapy	3.4	—
SECONDARY Change in R-ODS During IgPro10 Re-stabilization Therapy	4.7	—
SECONDARY Change in INCAT During IgPro10 Re-stabilization Therapy	-1.1	—
SECONDARY Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy	0.175	—
SECONDARY Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy	100	—
SECONDARY Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy	48.3	—
SECONDARY Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy	23	—
SECONDARY Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy	0.142	—
SECONDARY Number of Subjects With Adverse Events During IgPro10 Rescue Therapy	17	—
SECONDARY Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy	28.3	—
SECONDARY Change in Mean Grip Strength During IgPro10 Rescue Therapy	16.3	—
SECONDARY Change in MRC Sum Score During IgPro10 Rescue Therapy	6.8	—
SECONDARY Change in R-ODS During IgPro10 Rescue Therapy	14.0	—
SECONDARY Change in INCAT During IgPro10 Rescue Therapy	-1.3	—

Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP. Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo. The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.

Eligibility Criteria

Inclusion Criteria

Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.
An IVIG treatment during the last 8 weeks prior to enrollment.
Age ≥18 years.
Written informed consent for study participation obtained before undergoing any study-specific procedures.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01545076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.