NCT07076446

An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)

An Open-label, Multicenter Study to Assess the Pharmacokinetics, Safety, and Tolerability of Immune Globulin Subcutaneous (Human) IgPro20 in IG Treatment-naïve Subjects With Primary Immunodeficiency

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, phase 4 study in IG treatment-naïve participants with PID, conducted in the United States (US), to assess the PK, safety, and tolerability of IgPro20. The primary objective of this study is to characterize the PK of IgPro20 and to assess the safety and tolerability of IgPro20 in IG treatment-naïve participants with PID who are aged greater than or equal to (\>=) 18 years.

Conditions

• Primary Immunodeficiency

Interventions

Type	Name	Description
BIOLOGICAL	IgPro	IgPro20 is a solution for infusion for subcutaneous administration.

Timeline

• Start date: 2025-07-15
• Primary completion: 2026-05-04
• Completion: 2026-05-04
• First posted: 2025-07-22
• Last updated: 2025-12-11

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study