At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 23 enrolled
Drug / intervention
Donidalorsen +1 moredrug
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.
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Clinical Efficacy of ISIS 721744, a Second-Generation Ligand-Conjugated Antisense Inhibitor of Prekallikrein, in Patients With Hereditary Angioedema
In Brief
A Phase 2 clinical trial evaluating Donidalorsen and Placebo for Hereditary Angioedema. Completed, enrolled 23 participants across 8 sites in 2 countries.
Detailed Summary
The purpose of this study was to evaluate the clinical efficacy, safety, and tolerability of donidalorsen in participants with hereditary angioedema (HAE) type 1 (HAE-1), HAE type 2 (HAE-2), or HAE with normal C1-inhibitor (C1-INH) and to evaluate the effect of donidalorsen on plasma prekallikrein (PKK) and other relevant biomarkers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesNetherlands, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartJan 2020
Primary CompletionJan 2021
Study CompletionMar 2021
TodayJul 2026
First PostedJul 24, 2019
Enrollment StartJan 7, 2020
Primary CompletionJan 4, 2021
Study CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.9 years ago
Interventions
Donidalorsendrug
Donidalorsen administered SC
Placebodrug
Placebo matching solution administered SC