Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)
- Conditions
- efficacy and safety in subjects with diffuse cutaneous systemic sclerosisMedDRA version: 21.0Level: LLTClassification code 10012977Term: Diffuse systemic sclerosisSystem Organ Class: 100000004859MedDRA version: 20.0Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2019-000906-31-ES
- Lead Sponsor
- CSL Behring GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 188
1. Age =18 years (male or female) at time of providing written informed consent
2. Documented diagnosis of dcSSc according to ACR / EULAR criteria 2013
3. mRSS = 15 and = 45
4. Disease duration = 5 years defined as the time from the first non-Raynaud’s phenomenon manifestation
5. Subjects within first 18 months of disease duration from first non-Raynaud’s phenomenon manifestation. For those >18 to = 60 months, subjects with worsening of sclerodermatous skin involvement in one or more body areas (including any new areas of involvement) within 6 months prior to Screening and/or the presence of a tendon friction rub within 3 months prior to Screening as documented and determined by the investigator
based on medical history and medical records
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 188
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, and dermatomyositis, as determined by the investigator
Note: Subjects with fibromyalgia, secondary Sjogren’s syndrome, and scleroderma-associated myopathy or myositis at Screening are not excluded
2. Positive anti-centromere autoantibodies at Screening
3. Evidence of severe chronic kidney disease with estimated glomerular filtration rate < 30 mL/min/1.73m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) or receiving dialysis
4. History of documented thrombotic episode eg, PE, DVT, myocardial infarction, thromboembolic stroke at any time
Note: past superficial thrombophlebitis more than two years from Screening is not exclusionary
5. Documented thrombophilic abnormalities including blood hyperviscosity, protein S or protein C deficiency, anti-thrombin-3 deficiency, plasminogen deficiency, antiphospholipid syndrome, Factor V Leiden mutation, dysfibrinogenemia, or prothrombin G20210A mutation
6. Greater than 3 specified current risk factors for TEEs (documented and currents conditions): atrial fibrillation, coronary disease, diabetes mellitus, dyslipidemia, hypertension, obesity (Body Mass Index = 30 kg/m2), recent significant trauma, and immobility (wheelchair-bound or bedridden)
7. Ongoing active serious infection at Screening (including, but not limited to, pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess)
8. Malignancy in the past 2 years, except for non-melanoma skin cancer, cervical carcinoma in situ, or other in situ cancer if it has been excised and treated within in the past year
9. Known hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
10. Known IgA deficiency or serum IgA level < 5% lower limit of normal
11. Known or suspected antibodies to the IP, or to excipients of the IP.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate the efficacy of IgPro10 in comparison to placebo in adults with Diffuse systemic sclerosis (dcSSc) assessed by improvement as measured by American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis (ACR CRISS) score.;Secondary Objective: The secondary objectives of the study are to evaluate:<br>1. To further assess the efficacy of IgPro10 as compared to placebo <br>2. To assess safety of IgPro10 as compared to placebo<br>3. To assess the IgPro10 concentrations at steady state<br>4. To assess longer term efficacy and safety of IgPro10 at the end of an OL Treatment Period at Week 72.;Primary end point(s): Response on American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis (ACR CRISS) score in IgPro10 vs Placebo;Timepoint(s) of evaluation of this end point: over 48 weeks
- Secondary Outcome Measures
Name Time Method