Diffuse Cutaneous Systemic Sclerosis

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

NCT04138485 | PHASE 2 | INTERVENTIONAL

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.

77 Sites

0 Participants

WITHDRAWN

18 Years

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SUBMIT

Mayo Clinic Arizona Scottsdale

Scottsdale,Arizona,United States,85259

Pacific Arthritis Care Center

Los Angeles,California,United States,90045

University of California

Los Angeles,California,United States,90095

Stanford University Medical Center

Palo Alto,California,United States,94304

University of Colorado

Aurora,Colorado,United States,80045

Lombardi Cancer CenterGeorgetown University

Washington,District of Columbia,United States,20007

Alliance for Multispecialty Research

Wichita,Kansas,United States,67207

Heartland Research Associates, LLC

Wichita,Kansas,United States,67207

Louisiana State University Health Sciences Center

Shreveport,Louisiana,United States,71103

John Hopkins Bayview Medical Center

Baltimore,Maryland,United States,21287

Boston University Amyloidosis Center

Boston,Massachusetts,United States,02118

University of Michigan Health System

Ann Arbor,Michigan,United States,48108

Rutgers Clinical Research Center

New Brunswick,New Jersey,United States,08901

Northwell Health

Great Neck,New York,United States,11021

Hospital For Special Surgery

New York,New York,United States,10021

Cleveland Clinic Taussig Cancer Center

Cleveland,Ohio,United States,44195

Altoona Center For Research

Duncansville,Pennsylvania,United States,16635

University of Pennsylvania Perelman Center

Philadelphia,Pennsylvania,United States,19104

Medical University of South Carolina

Charleston,South Carolina,United States,29425

The University Of Texas Medical School At Houston (Utms)

Houston,Texas,United States,77030

APRILLUS Asistencia e Investigacion Clinica

Buenos Aires,Texas,Argentina,C1194AAO

Hospital Italiano de Buenos Aires

Buenos Aires,Texas,Argentina,S2000SDV

Hospital Militar Central

Ciudad Autonoma de Buenos Aires,Texas,Argentina,C1426AAL

Sanatorio Parque S.A y Consultorios Externos Asociados

Rosario,Texas,Argentina,C1181ACH

John Hunter Hospital Autoimmune Resource and Research Centre

New Lambton Heights,New South Wales,Australia,2305

PARC Clinical Research

Adelaide,South Australia,Australia,5005

UZ Gent

Gent,South Australia,Belgium,9000

Universitaire Ziekenhuizen Leuven Campus Gasthuisberg

Leuven,South Australia,Belgium,3000

Mount Sinai Hospital, The Rebecca Macdonald Centre For Arthritis

Toronto,South Australia,Canada,M5T3L9

CHU de Caen

Caen,South Australia,France,14000

CHRU de Lille Hopital Huriez

Lille Cedex,South Australia,France,59037

Internal Medicine, Nantes University Hospital

Nantes,South Australia,France,44000

Assistance Publique Hopitaux de Paris (APHP)

Paris,South Australia,France,75014

CHU de RennesHopital Sud

Rennes,South Australia,France,35203

Centre Hospitalier Universitaire de RouenHopital

Rouen cedex,South Australia,France,76000

CHU Hautepierre

Strasbourg,South Australia,France,67098

Kerckhoff Klinik GmbH, Abteilung fr Rheumatologie und Klinische Immunologie Rheumatologie

Bad Nauheim,South Australia,Germany,61231

Charite Universitaetsmedizin Berlin Campus Charite Mitte

Berlin,South Australia,Germany,10117

Universitaetsmedizin Berlin Campus Charite Mitte (CCM)

Berlin,South Australia,Germany,10117

Universitaetsklinikum Freiburg Klinik fuer Rheumatologie und Klinische Immunologie

Freiburg,South Australia,Germany,79106

University Hospital of Cologne

Köln,South Australia,Germany,50937

Universitaetsmedizin der Johannes Gutenberg

Mainz,South Australia,Germany,55131

University Hospital Of Tuebingen

Tuebingen,South Australia,Germany,72076

Universitaetsklinikum Ulm

Ulm,South Australia,Germany,89081

Hospital St. Josef

Wuppertal,South Australia,Germany,42105

Universita degli Study di Ancona

Ancona,South Australia,Italy,60121

Universita Degli Studi Di Bari Aldo Moro

Bari,South Australia,Italy,70121

Universita degli Studi Di Brescia

Brescia,South Australia,Italy,25123

Universita degli Studi Firenze

Firenze,South Australia,Italy,50139

UOC Immunoreumatologia

L'Aquila,South Australia,Italy,67100

Azienda Ospedaliera Gaetano Pini

Milano,South Australia,Italy,20122

Modena University

Modena,South Australia,Italy,41121

Universita degli Studi di Napoli Federico II

Napoli,South Australia,Italy,80138

IRCCS Policlinico San Matteo

Pavia,South Australia,Italy,27100

Dip.to Med. Sperimentale Polic.Umberto I Univ. La Sapienza

Rome,South Australia,Italy,00161

Centro de Investigacion y Tratamiento Reumatologico S.C.

Ciudad de México,South Australia,Mexico,11850

Centro Integral en Reumatologia, SA de CV

Guadalajara,South Australia,Mexico,44160

Centro De Estudios De Investigation Basica Y Clinica S.C

Jalisco,South Australia,Mexico,44690

Cliditer, S.A. DE C.V.

Mexico City,South Australia,Mexico,06700

Instituto Nacional De Ciencias Medicas Y Nutricion

Mexico,South Australia,Mexico,14080

Centro de Alta Especialidad en Reumatologia

San Luis Potosi,South Australia,Mexico,78213

Uniwersytecki Szpital Kliniczny W Bialymstoku

Bialystok,South Australia,Poland,15-369

University Clinical Centre, Medical University of Gdansk

Gdańsk,South Australia,Poland,80-211

Samodzielny Publiczny Szpital Kliniczny

Katowice,South Australia,Poland,40-635

Klinika Dermatologii Szpital im. Dziecitka Jezus

Warszawa,South Australia,Poland,00-001

Klinika i Poliklinika Ukadowych Chorb Tkanki cznej Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

Warszawa,South Australia,Poland,02-637

Complejo Hospitalario Universitario A Coruna

A Coruna,South Australia,Spain,15006

Hospital Universitari Materno Infantil Vall Dhebron

Barcelona,South Australia,Spain,08035

Hospital de la Santa Creu i Sant Pau

Barcelona,South Australia,Spain,08041

Hospital General Universitario Gregorio Maranon

Madrid,South Australia,Spain,28009

Hospital Univ de Octubre

Madrid,South Australia,Spain,28041

Hospital Infanta Luisa Quirnsalud

Sevilla,South Australia,Spain,41010

Hospital Universitari Dr.Peset

Valencia,South Australia,Spain,46017

Cantonal Hospital St. Gallen Klinik fuer Rheumatologie

Saint Gallen,South Australia,Switzerland,9007

Countess of Chester Hospital

Chester,South Australia,United Kingdom,CH21UL

Chapel Allerton Hospital

Leeds,South Australia,United Kingdom,LS74SA

Royal Free HospitalRoyal Free London NHS Foundation Trust

London,South Australia,United Kingdom,NW32QG

Study Eligibility Criteria

Inclusion Criteria

* 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 Criteria

* 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

Additional Studies

Additional studies can be found at ClinicalTrials.gov