Primary Immunodeficiency Clinical Trial
Official title:
A Multicenter, Randomized, Cross-over, Open-label Study to Evaluate IGSC 20% Flexible Dosing Including Daily Push Dosing In Treatment-Experienced Subjects With Primary Immunodeficiency (PI) and Evaluation of Loading/Maintenance IGSC 20% in Treatment-Naïve Subjects With PI
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).
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. There is an additional, separate cohort of
treatment-naïve, non-randomized subjects with PI who will not be part of the crossover.
Treatment-experienced subjects entering the study will maintain the same IgG dose (mg/kg)
received prestudy that will be normalized to the study-assigned dose-time interval (ie, there
will be 1:1 correspondence regardless of prestudy route of administration [intravenous [IV]
or SC]). Treatment-experienced subjects will be randomized in a 1:1:1 ratio into 1 of 3
parallel cohorts consisting of 18 subjects each as follows:
Cohort 1 (daily push compared with every 2 weeks [biweekly] pump) will evaluate syringe daily
push dosing versus every 2 weeks [biweekly] ambulatory pump administration. Subjects will be
randomized in a 1:1 ratio to 1 of 2 sequences, either beginning with syringe daily push
dosing for 16 weeks and then crossing over to ambulatory pump administration every 2 weeks
for 16 weeks or the reverse sequence.
Cohort 2 (daily push compared with once weekly pump) will evaluate syringe daily push dosing
versus once weekly ambulatory pump administration. Subjects will be randomized in a 1:1 ratio
to 1 of 2 sequences, either beginning with syringe daily push dosing for 16 weeks and then
crossing over to ambulatory pump administration once every week for 16 weeks or the reverse
sequence.
Cohort 3 (daily push compared with 2 times/week pump) will evaluate syringe daily push dosing
versus 2 times/week ambulatory pump administration. Ambulatory pump dosing will take place on
preselected days (eg, Monday and Thursday) not less than 3 days apart. The dosing days should
remain constant for the duration of the study. Subjects will be randomized in a 1:1 ratio to
1 of 2 sequences, either beginning with syringe daily push dosing for 16 weeks and then
crossing over to ambulatory pump administration 2 times/week for 16 weeks or the reverse
sequence.
The treatment-naïve cohort will receive a loading dose of 5 consecutive daily doses of IGSC
20% 150 mg/kg/day (Week 0, Days 1-5) followed by weekly infusions of 150 mg/kg starting Week
1 (Day 8) through Week 32 (end of Treatment Phase).
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