Phase 4Recruiting
Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza / Zemaira Weekly for 3 Years in Adults With alpha1 Antitrypsin Deficiency (AATD)
A Phase 4, Multicenter, Double-blind, Study to Investigate the Efficacy, Safety, and Tolerability of 3 Active Doses of Respreeza® / Zemaira® Weekly Intravenous Infusions Administered Over 3 Years as Longterm Maintenance Therapy in Adult Subjects With Emphysema Related to Alpha1 Antitrypsin Deficiency
- Sponsor
- CSL Behring (Industry)
- Enrolment
- 270 planned
- Conditions
- Alpha1 Antitrypsin Deficiency; Alpha1-Proteinase Inhibitor Deficiency; Emphysema
- Interventions
- CE1226
- Ages
- adults, older adults
- Registry
- NCT07326592, CTIS2025-522964-33-00
Full record on ClinicalTrials.gov
From the registry
This is a multicenter, parallel-group, double-blind, randomized phase 4 study designed to identify the optimal dose of CE1226 (2 active doses) to slow disease progression as assessed by reduced rates of annual lung density decline in alpha-1 antitrypsin (AAT) deficient participants over 3 years as compared with the marketed dose 60 milligrams per kilogram (mg/kg).
Primary outcomes
- Annual rate of change in adjusted lung density
History
Primary completion expected
Last registry update
Started
Registered