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

Last updated: February 21, 2025
Sponsor: CSL Behring
Overall Status: Terminated

Phase

3

Condition

Idiopathic Inflammatory Myopathies

Myositis

Collagen Vascular Diseases

Treatment

human immunoglobulin G

Placebo

Clinical Study ID

NCT04044690
IgPro20_3007
2018-003171-35
  • Ages > 18
  • All Genders

Study Summary

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on Total Improvement Score (TIS) assessments.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subjects ≥ 18 years of age

  • Diagnosis of at least probable idiopathic inflammatory myopathies (IIM) per EuropeanLeague Against Rheumatism/American College of Rheumatology (EULAR/ACR)Classification Criteria which includes confirmation of dermatomyositis (DM)rash/manifestation, disease activity defined by presence of DM rash / manifestationor an objective disease activity measure

  • Disease severity defined by Physician global activity visual analog scale (VAS) witha minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity ≥ 14.

  • Corticosteroid daily dose less than that or equal to 20 mg prednisolone equivalent

Exclusion

Exclusion Criteria:

  • Cancer-associated myositis

  • Evidence of active malignant disease or malignancies diagnosed within the previous 5years

  • Physician Global Damage score ≥ 3, or clinically relevant improvement betweenScreening Visit and Baseline

Study Design

Total Participants: 126
Treatment Group(s): 2
Primary Treatment: human immunoglobulin G
Phase: 3
Study Start date:
October 21, 2019
Estimated Completion Date:
December 02, 2024

Connect with a study center

  • 0320083 - Hospital Italiano de Buenos Aires

    Ciudad Autónoma Buenos Aires, Buenos Aires C1181ACH
    Argentina

    Site Not Available

  • 0320081 - Fundacion Respirar

    Buenos Aires, C1426ABP
    Argentina

    Site Not Available

  • 0320084 - DIM Clinica Privada

    Buenos Aires, B1704ETD
    Argentina

    Site Not Available

  • 0320077 - Centro Medico Privado de Reumatolgia

    Tucumán, T4000
    Argentina

    Site Not Available

  • 0360094 - Murdoch University

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • 0560050 - Ghent Universit Hospital (UZ Gent)

    Gent, 9000
    Belgium

    Site Not Available

  • 0560048 - Universitair Ziekenhuis (UZ) Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • 0560056 - Universitair Ziekenhuis Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • 0560049 - CHU de Liège - Sart Tilman

    Liège, 4000
    Belgium

    Site Not Available

  • 2030079 - Institute of Rheumatology

    Praha, 12800
    Czechia

    Site Not Available

  • 2500146 - CHU De Dijon Hopital Du Bocage

    Dijon, 21079
    France

    Site Not Available

  • 2500188 - Centre Hospitalier Regional Universitaire de Lille

    Lille Cedex, 59037
    France

    Site Not Available

  • 2500133 - CHU - Hospital de la Timone

    Marseille, 13385
    France

    Site Not Available

  • 2500135 - CHU Nice-Hopital Archet I

    Nice, 06202
    France

    Site Not Available

  • 2500132 - Hopital Pitie-Salpetriere

    Paris, 75013
    France

    Site Not Available

  • 2500144 - Hopitaux Universitaire de Strasbourg

    Strasbourg, 67098
    France

    Site Not Available

  • 2760203 - Charité

    Berlin, 10117
    Germany

    Site Not Available

  • 2760211 - Charité - Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • 2760271 - Universitatsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • 2760273 - Hautklinik des Uni-Klinikums Erlangen

    Erlangen, 91504
    Germany

    Site Not Available

  • 2760094 - University Essen

    Essen, 45147
    Germany

    Site Not Available

  • 2760036 - University Medicine Göttingen

    Göttingen, 37075
    Germany

    Site Not Available

  • 2760197 - Universitätsklinikum Hamburg-Eppendorf (UKE)

    Hamburg, 20246
    Germany

    Site Not Available

  • 2760201 - Medizinische Hochschule Hannover (MHH)

    Hannover, 30625
    Germany

    Site Not Available

  • CSLB Research Site

    Koeln, 50937
    Germany

    Site Not Available

  • 2760199 - University Hospital Köln

    Köln, 50937
    Germany

    Site Not Available

  • 2760210 - University of Münster

    Münster, 48149
    Germany

    Site Not Available

  • 2760212 - University Hospital Of Tuebingen

    Tuebingen, 72076
    Germany

    Site Not Available

  • 2760268 - University of Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • 3480048 - University of Debrecen

    Debrecen, 4032
    Hungary

    Site Not Available

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

    Brescia, 25123
    Italy

    Site Not Available

  • 3800132 - Universitaria Vittorio Emanuele

    Catania, 95124
    Italy

    Site Not Available

  • 3800139 - Universita degli Studi Firenze

    Firenze, 50134
    Italy

    Site Not Available

  • 3800134 - Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124
    Italy

    Site Not Available

  • 3800135 - University of Sacred Heart Policlinico A. Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • 3920096 - Chukyo Hospital

    Nagoya, Aichi 457-8510
    Japan

    Site Not Available

  • 3920090 - University Of Fukui Hospital

    Yoshida-Gun, Fukui 910-1193
    Japan

    Site Not Available

  • Gunma University Hospital

    Maebashi, Gunma 371-6511
    Japan

    Site Not Available

  • 3920088 - Gunma University Hospital

    Maebashi City, Gunma 371-6511
    Japan

    Site Not Available

  • 3920089 - Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Site Not Available

  • 3920086 - St. Marianna University Hospital

    Kawasaki, Kanagawa 216-8511
    Japan

    Site Not Available

  • 3920125 - Tokyo Medical And Dental University Medical Hospital

    Bunkyo, Tokyo 113-8519
    Japan

    Site Not Available

  • The University of Tokyo Hospital

    Bunkyo-Ku, Tokyo 113-8655
    Japan

    Site Not Available

  • 3920091 - Nippon Medical School Hospital

    Bunkyō-Ku, Tokyo 113-8603
    Japan

    Site Not Available

  • 3920097 - Tokyo Women's Medical University Hospital

    Shinjuku-Ku, Tokyo 162-8666
    Japan

    Site Not Available

  • CSLB Research Site

    Fukui, 910-1193
    Japan

    Site Not Available

  • CSLB Research Site

    Kanagawa, 216-8511
    Japan

    Site Not Available

  • Tokyo Medical And Dental University Medical Hospital

    Tokyo, 113-8519
    Japan

    Site Not Available

  • 3920087 - Wakayama Medical University Hospital

    Wakayama, 641-8509
    Japan

    Site Not Available

  • 3920035 - Yamaguchi University Hospital

    Yamaguchi, 755-8505
    Japan

    Site Not Available

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

    Ciudad de México, Distrito Federal 11850
    Mexico

    Site Not Available

  • CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.

    Mexico, Distrito Federal 11850
    Mexico

    Site Not Available

  • 4840081 - Centro Integral en Reumatologia, SA de CV

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Centro Peninsular De Investigacion Clinica SCP -Perez Ponce

    Merida, 97000
    Mexico

    Site Not Available

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

    San Luis Potosí, 78213
    Mexico

    Site Not Available

  • 5280065 - Amsterdam Universitair Medische Centra (UMC)

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • 6160106 - Specjalistyczne Gabinety Sp. z o.o

    Krakow, 30-539
    Poland

    Site Not Available

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

    Lublin, 20-582
    Poland

    Site Not Available

  • Centrum Medyczne Grunwald

    Poznań, 60-369
    Poland

    Site Not Available

  • 6160105 - Samodzielny Publiczny Szpital

    Szczecin, 70-111
    Poland

    Site Not Available

  • 6160117 - MedicalConcierge Centrum Medyczne

    Warszawa, 02-798
    Poland

    Site Not Available

  • CSLB Research Site

    Ekaterinburg, 620102
    Russian Federation

    Site Not Available

  • 6430124 - ORIS Firm Limited Liability Company

    Moscow, 117321
    Russian Federation

    Site Not Available

  • 6430122 - City Clinical Hospital No. 5

    Nizhniy Novgorod, 603005
    Russian Federation

    Site Not Available

  • Municipal Medicoprophylactyc Institution

    Nizhny Novgorod, 603005
    Russian Federation

    Site Not Available

  • 6430125 - Medical Centre-Healthy Family

    Novosibirsk, 630099
    Russian Federation

    Site Not Available

  • 6430120 - St. Petersburg City Rheumatological Hospital 25

    Saint Petersburg, 190068
    Russian Federation

    Site Not Available

  • 6430123 - Yaroslavl Oblast Clinical Hospital

    Yaroslavl, 150007
    Russian Federation

    Site Not Available

  • 7240086 - Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006
    Spain

    Site Not Available

  • 7240011 - Hospital Universitario Valle de Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • 7240112 - Hospital Clinic Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • 7560033 - University Hospital Bern Inselspital

    Bern, 3010
    Switzerland

    Site Not Available

  • 7560028 - Kantonsspital St. Gallen

    Saint Gallen, 9007
    Switzerland

    Site Not Available

  • 8040053 - Cherkassy Regional Hospital

    Cherkasy, 18009
    Ukraine

    Site Not Available

  • 8040055 - Mechnikov Institute of Microbiology and Immunology

    Kharkiv, 61029
    Ukraine

    Site Not Available

  • 8040057 - Khmelnitskiy Regional Hospital

    Khmelnytskyi, 29000
    Ukraine

    Site Not Available

  • 8040058 - State Institution National Scientific Center Strazhesko

    Kiev, 03151
    Ukraine

    Site Not Available

  • 8040051 - Kyiv Railway Clinical Hospital No.2

    Kyiv, 03049
    Ukraine

    Site Not Available

  • 8040052 - Institute of Rheumatology

    Kyiv, 02081
    Ukraine

    Site Not Available

  • 8040054 - Modern Clinic LLC

    Zaporizhia, 69005
    Ukraine

    Site Not Available

  • 8260119 - Doncaster Royal Infirmary

    Doncaster, DN2 5LT
    United Kingdom

    Site Not Available

  • 8401117 - Arizona Arthritis & Rheumatology Research

    Glendale, Arizona 85306
    United States

    Site Not Available

  • 8401199 - Neuromuscular Research Center

    Phoenix, Arizona 85028
    United States

    Site Not Available

  • 8401129 - UCLA - Rheumatology Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • Sutter Pacific Medical Foundation FORBES Norris MDA ALS Research and Treatment Center

    San Francisco, California 94115
    United States

    Site Not Available

  • 8401473 - RecioMed Clinical Research Network, Inc.

    Boynton Beach, Florida 33472
    United States

    Site Not Available

  • 8401160 - Center For Rheumatology

    Fort Lauderdale, Florida 33334
    United States

    Site Not Available

  • 8401132 - Omega Research Maitland

    Orlando, Florida 32810
    United States

    Site Not Available

  • 8401107 - Morsani Center for Advanced Health Care (CAHC)

    Tampa, Florida 33616
    United States

    Site Not Available

  • 8401152 - The University of Kansas Medical Center

    Fairway, Kansas 66205
    United States

    Site Not Available

  • 8401476 - DS Research

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • 8401111 - Ochsner Clinic Foundation

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • 8401130 - University Of Michigan

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • University of Missouri Health Care

    Columbia, Missouri 65212
    United States

    Site Not Available

  • 8401181 - Northwell Health Physicians

    Great Neck, New York 11021
    United States

    Site Not Available

  • 8400169 - HSS-Weill Medical College of Cornell University

    New York, New York 10021
    United States

    Site Not Available

  • 8401487 - Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • 8401131 - Paramount Medical Research & Consulting

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • 8401486 - Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • 8401210 - University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • 8401151 - Biomedical Science Tower

    Pittsburgh, Pennsylvania 15261
    United States

    Site Not Available

  • 8401113 - Wesley Neurology Clinic

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • 8401474 - West Tennessee Research Institute, LLC

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • 8401115 - The University of Texas Medical School at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Southwest Rheumatology Research

    Mesquite, Texas 75150
    United States

    Site Not Available

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