Phase 3
Completed N=82
Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) · Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Source: ClinicalTrials.gov NCT02027701 ↗
Enrolled (actual)
82
Serious AEs
8.5%
Results posted
Oct 2018
Primary outcomePrimary: Number of Adverse Events (AEs) Per Infusion — 0.032 Adverse events per infusion
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study is an extension study to the pivotal study IgPro20\_3003 (NCT01545076). The purpose of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with regard to safety and efficacy.
Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20\_3003 (NCT01545076) will have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment. Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.
The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events (AEs) Per Infusion |
0.032 | — |
| SECONDARY Time to First CIDP Relapse |
266.0 | — |
| SECONDARY Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score |
0.0 | — |
| SECONDARY Change From Baseline in Medical Research Council (MRC) Score |
0.0 | — |
| SECONDARY Change From Baseline in Rasch-built Overall Disability Scale (R-ODS) |
0.0 | — |
| SECONDARY Change From Baseline in Mean Grip Strength |
-0.7 | — |
| SECONDARY Percentage of Subjects With Adverse Events (AEs) |
75.6 | — |
| SECONDARY Number of AEs by Severity Per Infusion |
0.024; 0.006; 0.002 | — |
| SECONDARY Percentage of Subjects With AEs by Severity |
62.2; 29.3; 9.8 | — |
| SECONDARY Number of Causally Related AEs Per Infusion |
0.011 | — |
| SECONDARY Percentage of Subjects With Causally Related AEs |
25.6 | — |
| SECONDARY Number of Serious AEs Per Infusion |
0.001 | — |
| SECONDARY Percentage of Subjects With Serious AEs |
8.5 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects having completed the pivotal study IgPro20\_3003 (SC Week 25) or successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20\_3003 (NCT01545076).
- Written informed consent for study participation obtained before undergoing any study-specific procedures.
Exclusion Criteria
- Subject is unable to directly transition from study IgPro20\_3003.
- New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse) during participation in study IgPro20\_3003 that in the judgment of the investigator could increase risk to the subject, interfere with the evaluation of investigational medicinal product, and/or conduct of the study.
Data sourced from ClinicalTrials.gov (NCT02027701). 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. Informational only — not medical advice.