This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (HAE). The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
157
Navenibart will be administered as a subcutaneous injection.
Placebo will be administered as a subcutaneous injection.
Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period.
Time frame: Day 1 through Day 181
Number of moderate or severe investigator-confirmed HAE attacks during the 6-month Treatment Period.
Time frame: Day 1 through Day 181
Number of investigator-confirmed HAE attacks that require on-demand treatment during the 6-month Treatment Period.
Time frame: Day 1 through Day 181
Percent reduction in monthly investigator-confirmed HAE attacks in the 6-month Treatment Period versus the Run-In Period.
Time frame: Baseline through Day 181
Time to first investigator-confirmed HAE attack after first and second dose.
Time frame: Day 1 through Day 181
The number of participants responding to treatment, defined as a ≥ 50%, ≥ 70%, or ≥ 90% reduction from the Run-In Period in investigator-confirmed HAE attack rate (for adult participants: compared to placebo during the 6-month Treatment Period).
Time frame: Baseline through Day 181
Number of participants with no investigator-confirmed HAE attacks during the 6-month Treatment Period.
Time frame: Day 1 through Day 181
Change from baseline (Day 1) in the Angioedema Quality of Life questionnaire total score.
Time frame: Day 1 through Day 181
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