Respreeza 1

DRUG3 trials

Sponsors

Sanofi AATD Inc., CSL Behring LLC

Conditions

Acute Graft versus host diseaseAlpha-1 Antitrypsin Deficiency (AATD) EmphysemaAlpha1 antitrypsin deficiencyAlpha1-proteinase inhibitor deficiencyEmphysema

Phase 2

A Phase 2, Double-blind, Randomized, Active-control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and safety of SAR447537 (INBRX-101) Compared to Plasma Derived Apha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults with Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

CompletedCTIS2023-508084-76-00

Sanofi AATD Inc.Alpha-1 Antitrypsin Deficiency (AATD) Emphysema

Start: 2024-05-31End: 2025-05-28Target: 34Updated: 2025-03-27

A Phase 2/3, Multicenter, randOmized, Double-blind, placebo-controlled, stUdy to evaLuate the safety and efficacy of Alpha-1 AntiTrypsin for the prEvention of graft versus-host disease in patients receiving hematopoietic cell transplant (MODULAATE Study)

CompletedCTIS2024-511164-92-00

CSL Behring LLCAcute Graft versus host disease

Start: 2019-05-17End: 2026-01-12Target: 55Updated: 2025-10-21

Phase 4

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

Not yet recruitingCTIS2025-522964-33-00

CSL Behring LLCAlpha1 antitrypsin deficiency, Alpha1-proteinase inhibitor deficiency, Emphysema

Target: 33Updated: 2026-05-28