NCT07326592

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Alpha1 Antitrypsin Deficiency
• Alpha1-Proteinase Inhibitor Deficiency
• Emphysema

Interventions

Type	Name	Description
BIOLOGICAL	CE1226	CE1226 will be administered via intravenous (IV) infusion weekly over 3 years.

Timeline

• Start date: 2026-04-15
• Primary completion: 2033-09-15
• Completion: 2033-09-15
• First posted: 2026-01-08
• Last updated: 2026-03-06

Regulatory

• FDA-regulated drug study