At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 73 enrolled
Drug / intervention
Lanadelumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)
In Brief
A Phase 3 clinical trial evaluating Lanadelumab for Angioedema. Completed, enrolled 73 participants across 35 sites in 10 countries.
Detailed Summary
The purpose of this study is to evaluate the long-term safety and efficacy of repeated subcutaneous (SC) administration of lanadelumab in adolescents and adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303 (NCT04206605).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAngioedema
CountriesCanada, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Spain, United States
CollaboratorsTakeda Development Center Americas, Inc.
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJun 2020
Enrollment StartFeb 2021
Primary CompletionMay 2023
TodayJul 2026
First PostedJun 24, 2020
Enrollment StartFeb 5, 2021
Primary CompletionMay 5, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.0 years ago
Interventions
Lanadelumabdrug
Lanadelumab SC injection