A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Summary
The aim of this study is to learn more about the following treatment options in adults with CIDP: * Subcutaneous self-infusion with HyQvia. * Intravenous infusion with Gammagard/Kiovig. Gammagard and Kiovig are the brand names for the same immunoglobulin compound. The study is in two parts. In Part 1, participants receive either HyQvia or a placebo subcutaneously. In Part 2 (only for participants who have a CIPD relapse during Part 1), participants will receive Gammagard Liquid/Kiovig intravenously. US participants will receive Gamunex-C. The first SC infusion will be given in the study clinic. The remaining SC infusions may be given in the study clinic or the participant's home. This will be decided by the study doctor and whether the participant or their caregiver can do the self-infusion.
Timeline
- Start
- 2015-12-15
- Primary completion
- 2022-02-23
- Completion
- 2022-02-23
Outcome
Met primary endpoint
registry analysis (superiority test); Epoch 1: Placebo With rHuPH20 vs Epoch 1: HYQVIA/HyQvia; p =0.0045 NCT02549170 ↗
release “Positive Opinion Based on Phase 3 ADVANCE-CIDP 1 Study, Which Met its Primary Endpoint Demonstrating a Statistically Significant Reduction in Relapse Rate” takeda.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gamunex-C | Protein / enzyme biologic | — | Intravenous |
| Subject | Immune Globulin Infusion 10% (Human) | Protein / enzyme biologic | — | Subcutaneous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | — | Intravenous |
| Background | recombinant human hyaluronidase | Protein / enzyme biologic | — | Subcutaneous |