Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)
NCT ID: NCT04138485
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2019-12-20
2020-09-16
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IgPro10
10% liquid formulation of human immunoglobulin for intravenous use
IgPro10
10% liquid formulation of human immunoglobulin for IVIG
Placebo
0.5% human albumin solution stabilized with 250 mmol/L L-proline
Placebo
0.5% human albumin solution stabilized with 250 mmol/L L-proline
Interventions
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IgPro10
10% liquid formulation of human immunoglobulin for IVIG
Placebo
0.5% human albumin solution stabilized with 250 mmol/L L-proline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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Mayo Clinic Arizona - Scottsdale
Scottsdale, Arizona, United States
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
PARC Clinical Research
Adelaide, South Australia, Australia
UZ Gent
Ghent, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
Mount Sinai Hospital, The Rebecca Macdonald Centre For Arthritis
Toronto, , Canada
CHU de Caen
Caen, , France
CHRU de Lille Hopital Huriez
Lille, , France
Internal Medicine, Nantes University Hospital
Nantes, , France
Assistance Publique - Hopitaux de Paris (AP-HP)
Paris, , France
CHU de Rennes-Hopital Sud
Rennes, , France
Centre Hospitalier Universitaire de Rouen-Hopital
Rouen, , France
CHU Hautepierre
Strasbourg, , France
Kerckhoff Klinik GmbH, Abteilung für Rheumatologie und Klinische Immunologie Rheumatologie
Bad Nauheim, , Germany
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, , Germany
Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, , Germany
University Hospital of Cologne
Cologne, , Germany
Universitaetsklinikum Freiburg- Klinik fuer Rheumatologie und Klinische Immunologie
Freiburg im Breisgau, , Germany
Universitaetsmedizin der Johannes Gutenberg
Mainz, , Germany
University Hospital Of Tuebingen
Tübingen, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Hospital St. Josef
Wuppertal, , Germany
Universita degli Study di Ancona
Ancona, , Italy
Universita Degli Studi Di Bari Aldo Moro
Bari, , Italy
Universita degli Studi Di Brescia
Brescia, , Italy
Universita degli Studi Firenze
Florence, , Italy
UOC Immunoreumatologia
L’Aquila, , Italy
Azienda Ospedaliera Gaetano Pini
Milan, , Italy
Modena University
Modena, , Italy
Universita degli Studi di Napoli Federico II
Napoli, , Italy
IRCCS Policlinico San Matteo
Pavia, , Italy
Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza
Rome, , Italy
Centro Integral en Reumatologia, SA de CV
Guadalajara, , Mexico
Centro De Estudios De Investigation Basica Y Clinica S.C
Jalisco, , Mexico
Cliditer, S.A. DE C.V.
Mexico City, , Mexico
Centro de Investigacion y Tratamiento Reumatologico S.C.
Mexico City, , Mexico
Instituto Nacional De Ciencias Medicas Y Nutricion
México, , Mexico
Centro de Alta Especialidad en Reumatologia
San Luis Potosí City, , Mexico
Uniwersytecki Szpital Kliniczny W Bialymstoku
Bialystok, , Poland
University Clinical Centre, Medical University of Gdansk
Gdansk, , Poland
Samodzielny Publiczny Szpital Kliniczny
Katowice, , Poland
Klinika Dermatologii Szpital im. Dzieciątka Jezus
Warsaw, , Poland
Klinika i Poliklinika Układowych Chorób Tkanki Łącznej Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, , Poland
Complejo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital Universitari Materno Infantil Vall Dhebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Univ 12 de Octubre
Madrid, , Spain
Hospital Infanta Luisa Quirónsalud
Seville, , Spain
Hospital Universitari Dr.Peset
Valencia, , Spain
Cantonal Hospital St. Gallen - Klinik fuer Rheumatologie
Sankt Gallen, , Switzerland
Countess of Chester Hospital
Chester, , United Kingdom
Chapel Allerton Hospital
Leeds, , United Kingdom
Royal Free Hospital-Royal Free London NHS Foundation Trust
London, , United Kingdom
Countries
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Other Identifiers
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2019-000906-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IgPro10_2001
Identifier Type: -
Identifier Source: org_study_id