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

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 20, 2019

Primary Completion Date

September 16, 2020

Study Completion Date

September 16, 2020

Conditions
Diffuse Cutaneous Systemic Sclerosis
Interventions
BIOLOGICAL

IgPro10

10% liquid formulation of human immunoglobulin for IVIG

BIOLOGICAL

Placebo

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

Trial Locations (77)

2305

John Hunter Hospital / Autoimmune Resource and Research Centre, New Lambton Heights

3000

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

5005

PARC Clinical Research, Adelaide

9000

UZ Gent, Ghent

9007

Cantonal Hospital St. Gallen - Klinik fuer Rheumatologie, Sankt Gallen

10021

Hospital For Special Surgery, New York

10117

Charite - Universitaetsmedizin Berlin - Campus Charite Mitte, Berlin

Universitaetsmedizin Berlin - Campus Charite Mitte (CCM), Berlin

11021

Northwell Health, Great Neck

11850

Centro de Investigacion y Tratamiento Reumatologico S.C., Mexico City

14000

CHU de Caen, Caen

14080

Instituto Nacional De Ciencias Medicas Y Nutricion, México

15006

Complejo Hospitalario Universitario A Coruna, A Coruña

16635

Altoona Center For Research, Duncansville

19104

University of Pennsylvania - Perelman Center, Philadelphia

20007

Lombardi Cancer Center-Georgetown University, Washington D.C.

20122

Azienda Ospedaliera Gaetano Pini, Milan

21287

John Hopkins Bayview Medical Center, Baltimore

25123

Universita degli Studi Di Brescia, Brescia

27100

IRCCS Policlinico San Matteo, Pavia

28009

Hospital General Universitario Gregorio Maranon, Madrid

28041

Hospital Univ 12 de Octubre, Madrid

29425

Medical University of South Carolina, Charleston

35203

CHU de Rennes-Hopital Sud, Rennes

41010

Hospital Infanta Luisa Quirónsalud, Seville

41121

Modena University, Modena

42105

Hospital St. Josef, Wuppertal

44000

Internal Medicine, Nantes University Hospital, Nantes

44160

Centro Integral en Reumatologia, SA de CV, Guadalajara

44195

Cleveland Clinic - Taussig Cancer Center, Cleveland

44690

Centro De Estudios De Investigation Basica Y Clinica S.C, Jalisco

46017

Hospital Universitari Dr.Peset, Valencia

48108

University of Michigan Health System, Ann Arbor

50139

Universita degli Studi Firenze, Florence

50937

University Hospital of Cologne, Cologne

55131

Universitaetsmedizin der Johannes Gutenberg, Mainz

59037

CHRU de Lille Hopital Huriez, Lille

60121

Universita degli Study di Ancona, Ancona

61231

Kerckhoff Klinik GmbH, Abteilung für Rheumatologie und Klinische Immunologie Rheumatologie, Bad Nauheim

67098

CHU Hautepierre, Strasbourg

67100

UOC Immunoreumatologia, L’Aquila

67207

Alliance for Multispecialty Research, Wichita

Heartland Research Associates, LLC, Wichita

70121

Universita Degli Studi Di Bari Aldo Moro, Bari

71103

Louisiana State University Health Sciences Center, Shreveport

72076

University Hospital Of Tuebingen, Tübingen

75014

Assistance Publique - Hopitaux de Paris (AP-HP), Paris

76000

Centre Hospitalier Universitaire de Rouen-Hopital, Rouen

77030

The University Of Texas Medical School At Houston (Utms), Houston

78213

Centro de Alta Especialidad en Reumatologia, San Luis Potosí City

79106

Universitaetsklinikum Freiburg- Klinik fuer Rheumatologie und Klinische Immunologie, Freiburg im Breisgau

80045

University of Colorado, Aurora

80138

Universita degli Studi di Napoli Federico II, Napoli

85259

Mayo Clinic Arizona - Scottsdale, Scottsdale

89081

Universitaetsklinikum Ulm, Ulm

90045

Pacific Arthritis Care Center, Los Angeles

90095

University of California, Los Angeles

94304

Stanford University Medical Center, Palo Alto

02118

Boston University Amyloidosis Center, Boston

08901

Rutgers Clinical Research Center, New Brunswick

C1194AAO

APRILLUS Asistencia e Investigacion Clinica, Buenos Aires

C1426AAL

Hospital Militar Central, Buenos Aires

S2000SDV

Hospital Italiano de Buenos Aires, Buenos Aires

C1181ACH

Sanatorio Parque S.A y Consultorios Externos Asociados, Rosario

M5T 3L9

Mount Sinai Hospital, The Rebecca Macdonald Centre For Arthritis, Toronto

00161

Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza, Rome

06700

Cliditer, S.A. DE C.V., Mexico City

15-369

Uniwersytecki Szpital Kliniczny W Bialymstoku, Bialystok

80-211

University Clinical Centre, Medical University of Gdansk, Gdansk

40-635

Samodzielny Publiczny Szpital Kliniczny, Katowice

00-001

Klinika Dermatologii Szpital im. Dzieciątka Jezus, Warsaw

02-637

Klinika i Poliklinika Układowych Chorób Tkanki Łącznej Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji, Warsaw

08035

Hospital Universitari Materno Infantil Vall Dhebron, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

CH2 1UL

Countess of Chester Hospital, Chester

LS7 4SA

Chapel Allerton Hospital, Leeds

NW3 2QG

Royal Free Hospital-Royal Free London NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY