A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)

PHASE3TerminatedINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

October 21, 2019

Primary Completion Date

December 2, 2024

Study Completion Date

December 2, 2024

Conditions
Dermatomyositis
Interventions
DRUG

human immunoglobulin G

human immunoglobulin G administered subcutaneously

DRUG

Placebo

contains 2% human albumin, similar excipients as IgPro20 (Hizentra), same volume, same duration, administered subcutaneously

Trial Locations (76)

3000

0560048 - Universitair Ziekenhuis (UZ) Leuven, Leuven

0560056 - Universitair Ziekenhuis Leuven, Leuven

3010

7560033 - University Hospital Bern Inselspital, Bern

4000

0560049 - CHU de Liège - Sart Tilman, Liège

4032

3480048 - University of Debrecen, Debrecen

9000

0560050 - Ghent Universit Hospital (UZ Gent), Ghent

9007

7560028 - Kantonsspital St. Gallen, Sankt Gallen

10117

2760203 - Charité, Berlin

2760211 - Charité - Universitätsmedizin Berlin, Berlin

11850

4840082 - CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C., Mexico City

13385

2500133 - CHU - Hospital de la Timone, Marseille

15006

7240086 - Complejo Hospitalario Universitario A Coruña, A Coruña

15261

8401151 - Biomedical Science Tower, Pittsburgh

18009

8040053 - Cherkassy Regional Hospital, Cherkasy

19104

8401210 - University of Pennsylvania, Philadelphia

21079

2500146 - CHU De Dijon Hopital Du Bocage, Dijon

25123

3800133 - Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia, Brescia

29000

8040057 - Khmelnitskiy Regional Hospital, Khmelnytskyi

30625

2760201 - Medizinische Hochschule Hannover (MHH), Hanover

32810

8401132 - Omega Research Maitland, Orlando

33334

8401160 - Center For Rheumatology, Fort Lauderdale

33472

8401473 - RecioMed Clinical Research Network, Inc., Boynton Beach

33616

8401107 - Morsani Center for Advanced Health Care (CAHC), Tampa

37075

2760036 - University Medicine Göttingen, Göttingen

38305

8401474 - West Tennessee Research Institute, LLC, Jackson

40241

8401476 - DS Research, Louisville

43210

8401487 - Ohio State University, Columbus

44160

4840081 - Centro Integral en Reumatologia, SA de CV, Guadalajara

48149

2760210 - University of Münster, Münster

50134

3800139 - Universita degli Studi Firenze, Florence

50937

2760199 - University Hospital Köln, Cologne

56124

3800134 - Azienda Ospedaliero Universitaria Pisana, Pisa

59037

2500188 - Centre Hospitalier Regional Universitaire de Lille, Lille

61029

8040055 - Mechnikov Institute of Microbiology and Immunology, Kharkiv

66205

8401152 - The University of Kansas Medical Center, Fairway

67098

2500144 - Hopitaux Universitaire de Strasbourg, Strasbourg

69005

8040054 - Modern Clinic LLC, Zaporizhia

72076

2760212 - University Hospital Of Tuebingen, Tübingen

75013

2500132 - Hopital Pitie-Salpetriere, Paris

77030

8401115 - The University of Texas Medical School at Houston, Houston

78213

4840084 - Centro de Alta Especialidad en Reumatologia e Investigacion del Potosí, S.C., San Luis Potosí City

85028

8401199 - Neuromuscular Research Center, Phoenix

85306

8401117 - Arizona Arthritis & Rheumatology Research, Glendale

89081

2760268 - University of Ulm, Ulm

90095

8401129 - UCLA - Rheumatology Los Angeles, Los Angeles

91504

2760273 - Hautklinik des Uni-Klinikums Erlangen, Erlangen

95124

3800132 - Universitaria Vittorio Emanuele, Catania

97239

8401486 - Oregon Health and Science University, Portland

117321

6430124 - ORIS Firm Limited Liability Company, Moscow

150007

6430123 - Yaroslavl Oblast Clinical Hospital, Yaroslavl

190068

6430120 - St. Petersburg City Rheumatological Hospital 25, Saint Petersburg

603005

6430122 - City Clinical Hospital No. 5, Nizhny Novgorod

630099

6430125 - Medical Centre-Healthy Family, Novosibirsk

C1181ACH

0320083 - Hospital Italiano de Buenos Aires, Ciudad Autónoma Buenos Aires

B1704ETD

0320084 - DIM Clinica Privada, Buenos Aires

C1426ABP

0320081 - Fundacion Respirar, Buenos Aires

T4000

0320077 - Centro Medico Privado de Reumatolgia, San Miguel de Tucumán

06202

2500135 - CHU Nice-Hopital Archet I, Nice

01307

2760271 - Universitatsklinikum Carl Gustav Carus TU Dresden, Dresden

457-8510

3920096 - Chukyo Hospital, Nagoya

910-1193

3920090 - University Of Fukui Hospital, Yoshida-Gun

371-6511

3920088 - Gunma University Hospital, Maebashi

060-8648

3920089 - Hokkaido University Hospital, Sapporo

216-8511

3920086 - St. Marianna University Hospital, Kawasaki

113-8519

3920125 - Tokyo Medical And Dental University Medical Hospital, Bunkyo

113-8603

3920091 - Nippon Medical School Hospital, Bunkyō-Ku

162-8666

3920097 - Tokyo Women's Medical University Hospital, Shinjuku-Ku

641-8509

3920087 - Wakayama Medical University Hospital, Wakayama

755-8505

3920035 - Yamaguchi University Hospital, Yamaguchi

20-582

6160104 - Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr 2, Lublin

02-798

6160117 - MedicalConcierge Centrum Medyczne, Warsaw

08035

7240011 - Hospital Universitario Valle de Hebron, Barcelona

08036

7240112 - Hospital Clinic Barcelona, Barcelona

03151

8040058 - State Institution National Scientific Center Strazhesko, Kiev

02081

8040052 - Institute of Rheumatology, Kyiv

03049

8040051 - Kyiv Railway Clinical Hospital No.2, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY