NCT04137224

Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)

A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) and IgPro10 (Intravenous Immunoglobulin, Privigen®) in Adults With Systemic Sclerosis (SSc)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc). The pharmacokinetic study aims to evaluate the relative bioavailability of IgPro20, and characterize pharmacokinetics of IgPro20 and IgPro10, respectively, in participants with dcSSc. Safety, tolerability, and pharmacokinetics of IgPro10 will also be evaluated.

Conditions

• Diffuse Cutaneous Systemic Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	IgPro20	Human normal immunoglobulin for subcutaneous administration
BIOLOGICAL	IgPro10	Human normal immunoglobulin for intravenous administration

Timeline

• Start date: 2019-09-19
• Primary completion: 2022-05-17
• Completion: 2022-05-17
• First posted: 2019-10-23
• Last updated: 2024-02-05
• Results posted: 2024-02-05

Locations

9 sites across 5 countries: Australia, Germany, Italy, Poland, United Kingdom