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

Recruiting

18 Years to 35 Years

If interested, contact clinicaltrials@cslbehring.com for more information

CSL Behring respects your privacy. For an explanation of how CSL Behring will use the information you are submitting, please view our Privacy Policy

Find closest sites:

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,Argentina,C1194AAO

Hospital Italiano de Buenos Aires

Buenos Aires,Argentina,S2000SDV

Hospital Militar Central

Ciudad Autonoma de Buenos Aires,Argentina,C1426AAL

Sanatorio Parque S.A y Consultorios Externos Asociados

Rosario,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,Belgium,9000

Universitaire Ziekenhuizen Leuven Campus Gasthuisberg

Leuven,Belgium,3000

Mount Sinai Hospital, The Rebecca Macdonald Centre For Arthritis

Toronto,Canada,M5T3L9

CHU de Caen

Caen,France,14000

CHRU de Lille Hopital Huriez

Lille Cedex,France,59037

Internal Medicine, Nantes University Hospital

Nantes,France,44000

Assistance Publique Hopitaux de Paris (APHP)

Paris,France,75014

CHU de RennesHopital Sud

Rennes,France,35203

Centre Hospitalier Universitaire de RouenHopital

Rouen cedex,France,76000

CHU Hautepierre

Strasbourg,France,67098

Kerckhoff Klinik GmbH, Abteilung fr Rheumatologie und Klinische Immunologie Rheumatologie

Bad Nauheim,Germany,61231

Charite Universitaetsmedizin Berlin Campus Charite Mitte

Berlin,Germany,10117

Universitaetsmedizin Berlin Campus Charite Mitte (CCM)

Berlin,Germany,10117

Universitaetsklinikum Freiburg Klinik fuer Rheumatologie und Klinische Immunologie

Freiburg,Germany,79106

University Hospital of Cologne

Köln,Germany,50937

Universitaetsmedizin der Johannes Gutenberg

Mainz,Germany,55131

University Hospital Of Tuebingen

Tuebingen,Germany,72076

Universitaetsklinikum Ulm

Ulm,Germany,89081

Hospital St. Josef

Wuppertal,Germany,42105

Universita degli Study di Ancona

Ancona,Italy,60121

Universita Degli Studi Di Bari Aldo Moro

Bari,Italy,70121

Universita degli Studi Di Brescia

Brescia,Italy,25123

Universita degli Studi Firenze

Firenze,Italy,50139

UOC Immunoreumatologia

L'Aquila,Italy,67100

Azienda Ospedaliera Gaetano Pini

Milano,Italy,20122

Modena University

Modena,Italy,41121

Universita degli Studi di Napoli Federico II

Napoli,Italy,80138

IRCCS Policlinico San Matteo

Pavia,Italy,27100

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

Rome,Italy,00161

Centro de Investigacion y Tratamiento Reumatologico S.C.

Ciudad de México,Mexico,11850

Centro Integral en Reumatologia, SA de CV

Guadalajara,Mexico,44160

Centro De Estudios De Investigation Basica Y Clinica S.C

Jalisco,Mexico,44690

Cliditer, S.A. DE C.V.

Mexico City,Mexico,06700

Instituto Nacional De Ciencias Medicas Y Nutricion

Mexico,Mexico,14080

Centro de Alta Especialidad en Reumatologia

San Luis Potosi,Mexico,78213

Uniwersytecki Szpital Kliniczny W Bialymstoku

Bialystok,Poland,15-369

University Clinical Centre, Medical University of Gdansk

Gdańsk,Poland,80-211

Samodzielny Publiczny Szpital Kliniczny

Katowice,Poland,40-635

Klinika Dermatologii Szpital im. Dziecitka Jezus

Warszawa,Poland,00-001

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

Warszawa,Poland,02-637

Complejo Hospitalario Universitario A Coruna

A Coruna,Spain,15006

Hospital Universitari Materno Infantil Vall Dhebron

Barcelona,Spain,08035

Hospital de la Santa Creu i Sant Pau

Barcelona,Spain,08041

Hospital General Universitario Gregorio Maranon

Madrid,Spain,28009

Hospital Univ de Octubre

Madrid,Spain,28041

Hospital Infanta Luisa Quirnsalud

Sevilla,Spain,41010

Hospital Universitari Dr.Peset

Valencia,Spain,46017

Cantonal Hospital St. Gallen Klinik fuer Rheumatologie

Saint Gallen,Switzerland,9007

Countess of Chester Hospital

Chester,United Kingdom,CH21UL

Chapel Allerton Hospital

Leeds,United Kingdom,LS74SA

Royal Free HospitalRoyal Free London NHS Foundation Trust

London,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