NCT05466747

A Study of RYMPHYSIA for Alpha1-Proteinase Inhibitor (A1PI) Therapy in Adults With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)-Emphysema

Randomized, Open-label, Parallel-group, Multicenter, Non-inferiority and Dose-response Study to Evaluate the Efficacy and Safety of RYMPHYSIA (ARALAST NP) for Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Subjects With A1PI Deficiency and Chronic Obstructive Pulmonary Disease-Emphysema

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the efficacy of RYMPHYSIA \[Alpha1-Proteinase Inhibitor (Human)\] compared to another available alpha-1 proteinase Inhibitor (A1PI) in adults with A1PI deficiency and COPD-emphysema. In Part A of the study, participants will be randomly assigned to receive either RYMPHYSIA or another available A1PI for 104 weeks. Participants who were randomized to another available A1PI will enter a 2-week follow-up period after the treatment phase is completed; participants who were randomized to RYMPHYSIA will enter Part B. In Part B, participants will be randomly assigned to one of two groups and will receive either the same dose of RYMPHYSIA as in Part A or a different dose for an additional 104 weeks, followed by a 2-week follow-up period.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)
• Alpha1-Antitrypsin Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	RYMPHYSIA	RYMPHYSIA administered through an IV injection.
BIOLOGICAL	Another Available A1PI	Another available A1PI administered through an IV injection.

Timeline

• Start date: 2024-01-01
• Primary completion: 2027-04-26
• Completion: 2029-05-07
• First posted: 2022-07-20
• Last updated: 2023-05-06

Regulatory

• FDA-regulated drug study