Safety & PK of IgPro20 & IgPro10 in Adults with Systemic Sclerosis
Research type
Research Study
Full title
A Multicenter, Randomised, Open Label, Crossover, Phase 2 Sudy to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc)
IRAS ID
261266
Contact name
Christopher Denton
Contact email
Sponsor organisation
CSL Behring GmbH
Eudract number
2018-003149-41
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
This is a randomised, multicenter, open label, crossover, phase 2 study evaluating the safety and pharmacokinetics (PK, movement of drug within the body) of immunoglobulin IgPro20 administered under the skin and immunoglobulin IgPro10 administered in to a vein in adults with Systemic Sclerosis(SSc).
The purpose of this study is to evaluate the safety of IgPro20 in adults with diffuse cutaneous SSc.
Diffuse cutaneous systemic sclerosis (dcSSc) is characterised by skin hardening (fibrosis) and problems in many organs of the body.
Diffuse cutaneous SSc is associated with numerous detrimental effects on health-related quality of life. Therefore, there is a high unmet medical need for new therapeutic options for the SSc patient population.
The study will measure the levels of IgPro20 in the blood after being administered subcutaneously (under the skin) as compared to when administered intravenously (in to a vein).
The study involves approximately 17 site visits over 40 weeks. Participants will be randomly assigned to one of the 2 treatment sequences: A or B.
If in Sequence A participants will receive 0.5g/kg IgPro20 subcutaneously over 16 weeks, followed by IgPro10 2g/kg administered intravenously over 16 weeks.
If in Sequence B participants will receive 2g/kg IgPro10 administered intravenously over 16 weeks, followed 0.5g/kg IgPro20 administered subcutaneously over 16 weeks
Approximately 26 eligible participants will be enroled and randomised to expect 20 evaluable participants to complete the study.
The duration of the study for an individual participant is expected to be up to 40 weeks, whereas the overall study duration (ie, first participants screening visit to last participants end of study visit) is expected to be approximately 24 months.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/0639
Date of REC Opinion
15 May 2019
REC opinion
Favourable Opinion