Status:
WITHDRAWN
Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)
Lead Sponsor:
CSL Behring
Conditions:
Diffuse Cutaneous Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (O...
Eligibility Criteria
Inclusion
- 1\. Age ≥18 years (male or female) at time of providing written informed consent
- Documented diagnosis of SSc according to ACR / EULAR criteria 2013
- mRSS ≥ 15 and ≤ 45
- Disease duration ≤ 5 years defined as the time from the first non-Raynaud's phenomenon manifestation
- Subjects within first 18 months of disease duration from first non-Raynaud's phenomenon manifestation.
Exclusion
- 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
- Positive anti-centromere autoantibodies at Screening
- Evidence of severe chronic kidney disease with estimated glomerular filtration rate \< 45 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) or receiving dialysis. Additionally, subjects with current confirmed diagnosis of diabetes mellitus and requiring medication, with eGFR \< 90 mL/min/1.73m2 will be excluded from the study.
- 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
- 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
- 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)
- Ongoing active serious infection at Screening (including, but not limited to, pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess)
- 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
- Known hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration \> 0.2 g/L)
- Known IgA deficiency or serum IgA level \< 5% lower limit of normal
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04138485
Start Date
December 20 2019
End Date
September 16 2020
Last Update
November 17 2020
Active Locations (77)
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1
Mayo Clinic Arizona - Scottsdale
Scottsdale, Arizona, United States, 85259
2
Pacific Arthritis Care Center
Los Angeles, California, United States, 90045
3
University of California
Los Angeles, California, United States, 90095
4
Stanford University Medical Center
Palo Alto, California, United States, 94304