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COMPLETED Phase 3

Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT02027701 · View on ClinicalTrials.gov ↗

Study 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 If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.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).

Interventions

  • BIOLOGICAL IgPro20

Study Locations (20)

Other

  • Site Reference 2030009 — Hradec Králové
  • Site Reference 2030002 — Hradec Králové
  • Site Reference 2500022 — Nice
  • Site Reference 2760069 — Berlin
  • Site Reference 2760072 — Berlin
  • Site Reference 2760049 — Bochum
  • Site Reference 2760094 — Essen
  • Site Reference 2760054 — Hanover
  • Site Reference 2760055 — Leipzig
  • Site Reference 2760047 — Potsdam

Alabama

  • Site Reference 8400181 — Birmingham

California

  • Site Reference 8400167 — Los Angeles

Kansas

  • Site Reference 8400166 — Kansas City

New York

  • Site Reference 8400169 — New York

North Carolina

  • Site Reference 8400182 — Charlotte

Queensland

  • Site Reference 0360017 — Woolloongabba

Victoria

  • Site Reference 0360011 — Fitzroy

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2014-07-30
Est. Completion 2017-07-10
Phase Phase 3

Sponsor

CSL Behring

85 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02027701

The ClinicalTrials.gov registry entry for NCT02027701 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) appearing as the primary indexed condition, and to 1 intervention — of which IgPro20 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02027701 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02027701 about?

NCT02027701 is a clinical study titled "Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)". 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 rescu...

What is the current status of trial NCT02027701?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 82 participants. The study started on 2014-07-30. Estimated completion is 2017-07-10.

What conditions does trial NCT02027701 study?

This clinical trial studies the following conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Polyradiculoneuropathy, Chronic Inflammatory Demyelinating. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02027701?

The interventions under investigation include: IgPro20 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02027701?

This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02027701 being conducted?

This trial has 20 study locations across Alabama, California, Kansas, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial