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

RetiradoFase 2ClinicalTrials.gov

ID: NCT04138485Tipo: INTERVENTIONALInicio: 20 de dic de 2019Fin estimado: 16 de sept de 2020

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Resumen

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 (OL) Treatment Period. Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

\. 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.

Criterios de exclusión

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

Intervenciones

biological

IgPro10

10% liquid formulation of human immunoglobulin for IVIG

biological

Placebo

0.5% human albumin solution stabilized with 250 mmol/L L-proline

Ubicaciones

APRILLUS Asistencia e Investigacion Clinica

Buenos Aires, Argentina

Hospital Militar Central

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Sanatorio Parque S.A y Consultorios Externos Asociados

Rosario, Argentina

Patrocinadores

PrincipalCSL Behring

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