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Diffuse Cutaneous Systemic Sclerosis

Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
NCT04137224 | PHASE 2 | INTERVENTIONAL

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.

Trial Information
9 Sites
27 Participants
COMPLETED
18 Years

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Royal Adelaide Hospital
Adelaide,South Australia,Australia,5000
Charit Universittsmedizin Berlin
Berlin,South Australia,Germany,10117
Uniklinik Kln, innere Medizin
Köln,South Australia,Germany,50937
ASST Spedali Civili di Brescia
Brescia,South Australia,Italy,25123
Azienda Ospedaliera Gaetano Pini
Milano,South Australia,Italy,20122
Uniwersytecki Szpital Kliniczny W Bialymstoku
Bialystok,South Australia,Poland,15-276
Szpital Kliniczny Jezus
Warsaw,South Australia,Poland,02-008
Narodowy Instytut Geriatrii
Warsaw,South Australia,Poland,02-637
The Royal Free Hospital
London,South Australia,United Kingdom,NW32QG

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov