IgPro10_2001_Efficacy&Safety of IgPro10_Adults with Systemic Sclerosis
Research type
Research Study
Full title
A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis
IRAS ID
274458
Contact name
Christopher Denton
Contact email
Sponsor organisation
CSL Behring GmbH
Eudract number
2019-000906-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Systemic sclerosis (SSc) is an autoimmune, connective tissue disorder characterised by disease in small blood vessels in the body and, autoantibody production (the body’s defence mechanism attacks the body), and an excess of collagen is deposited in the skin and internal organs.
This study is being carried out to see if IgPro10 is effective and tolerated when administered to adults with SSc who have skin thickness involvement throughout their body.
This form of SSc is called diffuse cutaneous systemic sclerosis (dcSSc). IgPro10 is a medication which is a protein found in the blood called immunoglobulin G (IgG). Immunoglobulins are responsible for neutralising harmful bacteria and viruses, toxins and allergens. IgPro10 is approved in 86 countries, including the United States and Europe under the brand name Privigen® for other diseases, but not for SSc, therefore IgPro10 in this study is an Investigational drug which means that the drug has not been approved by government agencies to treat SSc.
Currently, there are no approved therapies to slow down disease progression. Available therapeutic options are generally only partially effective and associated with unwanted and potentially severe side effects. Therefore, there is a high need for new treatment options for this disease. This study will evaluate the benefit and risks of IgPro10. It will be administered intravenously.
The study consists of a Screening period, two “Treatment Periods”: a Double-Blind Treatment Period (Masked Treatment Period), an Open-Label Treatment Period (Unmasked Treatment Period) and a Follow Up Period.
Approximately 144 participants with dcSSc will take part in this study. This study will include approximately 70 different study sites around the world.
Participation in the study will be approximately 80 weeks, depending on how many treatment periods patients choose to take part in.REC name
London - Hampstead Research Ethics Committee
REC reference
20/LO/0741
Date of REC Opinion
22 May 2020
REC opinion
Favourable Opinion