Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency

Summary

This is a prospective, multi-center, randomized, open-label, 2-period cross-over study (16 weeks per treatment period) to evaluate flexible dosing and daily push dosing of IGSC 20% in treatment-experienced subjects with PI. An additional, separate cohort of treatment-naïve, non-randomized subjects who will not be part of the crossover are included and will receive a loading dose of 5 consecutive daily doses of IGSC 20% followed by weekly infusions of IGSC 20% starting Week 1 (Day 8) through Week 32 (end of Treatment Phase). For treatment-experienced subjects, the study consists of a Screening Visit, Baseline Visit, 16-week Treatment Period 1, 16-week Treatment Period 2, and Final Visit/Early Termination Visit. For treatment-naïve subjects, the study consists of a Screening Visit, a Baseline Visit, a 32-week Treatment Phase, and Final Visit/Early Termination Visit. Approximately 54 treatment-experienced subjects and approximately 6 treatment-naïve subjects will be enrolled at study centers in the United States (US) and European Union (EU).

Timeline

Start

2019-12

Primary completion

2020-09

Completion

2020-09

Drugs

Indications