CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 91 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.

Search/NCT05139810
NCT05139810Phase 3Completed

A Phase 3 Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ISIS 721744 in Patients With Hereditary Angioedema (HAE)

Ionis Pharmaceuticals, Inc.·interventional·Posted Dec 1, 2021·Updated Mar 6, 2025

In Brief

A Phase 3 clinical trial evaluating Donidalorsen and Placebo for Hereditary Angioedema. Completed, enrolled 91 participants across 51 sites in 14 countries.

Detailed Summary

The purpose of this study was to evaluate the safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Bulgaria, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedDec 1, 2021
Enrollment StartDec 3, 2021
Primary CompletionNov 9, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.6 years ago

Interventions

Donidalorsendrug

Donidalorsen was administered by SC injection.

Placebodrug

Donidalorsen-matching placebo was administered by SC injection.