At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
Fazisiran Injection +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 Placebo-Controlled, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT) in Patients With Alpha-1 Antitrypsin Deficiency (AATD) [SEQUOIA]
In Brief
A Phase 2 clinical trial evaluating Fazisiran Injection and Placebo for Alpha 1-Antitrypsin Deficiency. Completed, enrolled 40 participants across 21 sites in 6 countries.
Detailed Summary
The purpose of AROAAT2001 (SEQUOIA) is to evaluate the safety, efficacy and tolerability of multiple doses of the investigational product, Fazirsiran Injection, administered subcutaneously to participants with alpha-1 antitrypsin deficiency (AATD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlpha 1-Antitrypsin Deficiency
CountriesGermany, Italy, Netherlands, Portugal, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartAug 2019
Primary CompletionNov 2021
Study CompletionSep 2023
TodayJul 2026
First PostedMay 10, 2019
Enrollment StartAug 7, 2019
Primary CompletionNov 8, 2021
Study CompletionSep 18, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.1 years ago
Interventions
Fazisiran Injectiondrug
solution for subcutaneous (sc) injection
Placeboother
sterile normal saline (0.9% NaCl), calculated to match active comparator, for sc injection