Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Diffuse Cutaneous Systemic Sclerosis

In brief

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.

Key facts

Study ID

NCT04138485

Run by

CSL Behring

People needed

0

Starts

2019-12-20

Expected to finish

2020-09-16

Last updated by the study team

2020-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Pacific Arthritis Care Center — Los Angeles, California, United States
• University of California — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• University of Colorado — Aurora, Colorado, United States
• Lombardi Cancer Center-Georgetown University — Washington D.C., District of Columbia, United States
• Alliance for Multispecialty Research — Wichita, Kansas, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• John Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Boston University Amyloidosis Center — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Rutgers Clinical Research Center — New Brunswick, New Jersey, United States
• Northwell Health — Great Neck, New York, United States
• Hospital For Special Surgery — New York, New York, United States
• Cleveland Clinic - Taussig Cancer Center — Cleveland, Ohio, United States
• Altoona Center For Research — Duncansville, Pennsylvania, United States
• University of Pennsylvania - Perelman Center — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• The University Of Texas Medical School At Houston (Utms) — Houston, Texas, United States
• 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
• John Hunter Hospital / Autoimmune Resource and Research Centre — New Lambton Heights, New South Wales, Australia
• Mayo Clinic Arizona - Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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