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Abstract Details

Rationale and Design of a Phase 3b Study of the Long-Term Tolerability and Safety of HyQvia in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP): ADVANCE-CIDP 3
Autoimmune Neurology
P5 - Poster Session 5 (8:00 AM-9:00 AM)
15-009
To describe the rationale and design of ADVANCE-CIDP 3 (NCT02955355).
Intravenous immunoglobulin (IVIG) therapy, a mainstay of CIDP treatment, requires venous access and is associated with a higher risk than subcutaneous immunoglobulin (SCIG) for systemic adverse events. However, hyaluronan limits conventional SCIG administration. HYQVIA® (Immune Globulin Infusion [Human] 10% with recombinant human hyaluronidase [rHuPH20]; fSCIG) allows for large-dose SCIG absorption by self-infusion at rates and volumes similar to or higher than IVIG, with potentially better systemic tolerability. The efficacy, safety, and tolerability of fSCIG in a targeted population of 174 adults who have CIDP are being investigated in the phase 3 ADVANCE-CIDP 1 study (NCT02549170).
ADVANCE-CIDP 3 is an open-label, noncontrolled, multicenter extension of ADVANCE-CIDP 1 and assesses long-term safety, tolerability, and immunogenicity of fSCIG as maintenance therapy to prevent relapse in CIDP. Planned enrollment is 148 patients. Eligible patients who completed Epoch 1 of ADVANCE-CIDP 1 without CIDP worsening will continue the same dose and regimen of fSCIG as the full dose received in Epoch 1 until relapse, approval of fSCIG for CIDP in the United States or European Union (whichever comes later), or a predetermined date according to the country of residence. Primary outcomes include occurrence of safety and tolerability events and incidence of anti-rHuPH20 antibodies. Exploratory outcomes are long-term effects on clinical outcome measures, quality of life, health utility, health resource utilization, treatment satisfaction, treatment preference, and patients’ global impression of change. Patients will be assessed at baseline (termination visit of ADVANCE-CIDP 1), postinfusion telephone calls, and study visits approximately every 12 weeks.
ADVANCE-CIDP 3 is ongoing. Eligible patients will roll over from ADVANCE-CIDP 1 for assessment of long-term effects of fSCIG in CIDP.
ADVANCE-CIDP 3 is designed to provide data that adequately support long-term safety, tolerability, and immunogenicity of fSCIG in CIDP.
Authors/Disclosures
Shabbir Hasan
PRESENTER 		Shabbir Hasan has received stock or an ownership interest from Takeda.
No disclosure on file
No disclosure on file
No disclosure on file
Shailesh Chavan Shailesh Chavan has received personal compensation for serving as an employee of Takeda Pharmaceuticals. Shailesh Chavan has received stock or an ownership interest from Takeda Pharmaceuticals.