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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
Recruiting
18 Years to 50 Years

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

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov