Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
Summary
This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Diseases (PIDD).
Timeline
- Start
- 2014-02
- Primary completion
- 2014-12
- Completion
- 2015-01
Outcome
Met primary endpoint
release “RI-002 has demonstrated positive Phase III results and successfully achieved its primary endpoint.” admabiologics.com ↗
release “RI-002 demonstrated positive results in a Phase III study in patients with PI, meeting its primary endpoint of no serious bacterial infections (SBI).” admabiologics.com ↗
release “ADMA’s lead product candidate, RI-002, has completed a Phase III clinical trial in patients with PIDD and has met the primary endpoint” admabiologics.com ↗
release “RI-002’s pivotal Phase III clinical trial successfully met its primary and secondary endpoints.” admabiologics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RI-002 | Unknown | 300 mg/kg | Intravenous |
| Subject | RI-002 | Unknown | 800 mg/kg | Intravenous |