CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
IgPro20 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04137224
NCT04137224Phase 2Completed
CompareCT.gov

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)

CSL Behring·interventional·Posted Oct 23, 2019·Updated Feb 5, 2024

In Brief

A Phase 2 clinical trial evaluating IgPro20 and IgPro10 for Diffuse Cutaneous Systemic Sclerosis. Completed, enrolled 27 participants across 9 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Cutaneous Systemic Sclerosis
CountriesAustralia, Germany, Italy, Poland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 23, 2019
Enrollment StartSep 19, 2019
Primary CompletionMay 17, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.7 years ago

Interventions

IgPro20biological

Human normal immunoglobulin for subcutaneous administration

IgPro10biological

Human normal immunoglobulin for intravenous administration