A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants with Hereditary Angioedema - ALPHA-ORBIT

Conditions

Hereditary Angioedema

Brief summary

Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period.

Detailed description

Number of moderate or severe investigator-confirmed HAE attacks during the 6-month Treatment Period., Number of investigator-confirmed HAE attacks that require on-demand treatment during the 6-month Treatment Period., Percent reduction in monthly investigator-confirmed HAE attacks in the 6-month Treatment Period versus the Run-In Period., Time to first investigator-confirmed HAE attack after first and second dose, 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)., Number of participants with no investigator-confirmed HAE attacks during the 6-month Treatment Period, Change from baseline (Day 1) in the Angioedema Quality of Life questionnaire total score., Other Pre-specified Outcome Measures: Incidence of treatment‑emergent adverse events.

Related papers

No related papers found yet.

Interventions

DRUGNavenibart - matching placebo

DRUGNavenibart

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of time-normalized investigator-confirmed HAE attacks during the 6-month Treatment Period.	—

Secondary

Measure	Time frame
Number of moderate or severe investigator-confirmed HAE attacks during the 6-month Treatment Period., Number of investigator-confirmed HAE attacks that require on-demand treatment during the 6-month Treatment Period., Percent reduction in monthly investigator-confirmed HAE attacks in the 6-month Treatment Period versus the Run-In Period., Time to first investigator-confirmed HAE attack after first and second dose, 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)., Number of participants with no investigator-confirmed HAE attacks during the 6-month Treatment Period, Change from baseline (Day 1) in the Angioedema Quality of Life questionnaire total score., Other Pre-specified Outcome Measures: Incidence of treatment‑emergent adverse events.	—

Measure

Time frame

Number of moderate or severe investigator-confirmed HAE attacks during the 6-month Treatment Period., Number of investigator-confirmed HAE attacks that require on-demand treatment during the 6-month Treatment Period., Percent reduction in monthly investigator-confirmed HAE attacks in the 6-month Treatment Period versus the Run-In Period., Time to first investigator-confirmed HAE attack after first and second dose, 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)., Number of participants with no investigator-confirmed HAE attacks during the 6-month Treatment Period, Change from baseline (Day 1) in the Angioedema Quality of Life questionnaire total score., Other Pre-specified Outcome Measures: Incidence of treatment‑emergent adverse events.

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Countries

Austria, Bulgaria, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed