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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female subjects ≥ 18 years of age.
  • - Diagnosis of at least probable idiopathic inflammatory myopathies (IIM) per European League 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 / manifestation or an objective disease activity measure.
  • - Disease severity defined by Physician global activity visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity score ≥ 14.
  • - Corticosteroid daily dose less than that or equal to 20 mg prednisolone equivalent.

Exclusion Criteria:

  • - Cancer-associated myositis.
  • - Evidence of active malignant disease or malignancies diagnosed within the previous 5 years.
- Physician Global Damage score ≥ 3, or clinically relevant improvement between Screening Visit and Baseline

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04044690
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

CSL Behring
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation CSL Behring
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, France, Germany, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Switzerland, Ukraine, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Dermatomyositis
Arms & Interventions

Arms

Experimental: IgPro20

human immunoglobulin G administered subcutaneously

Placebo Comparator: Placebo

human albumin solution administered subcutaneously

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Glendale, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Research

Glendale, Arizona, 85306

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[email protected]

610-878-4000

Neuromuscular Research Center, Phoenix, Arizona

Status

Recruiting

Address

Neuromuscular Research Center

Phoenix, Arizona, 85028

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610-878-4000

University Of California Los Angeles, Los Angeles, California

Status

Recruiting

Address

University Of California Los Angeles

Los Angeles, California, 90095

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[email protected]

610-878-4000

San Francisco, California

Status

Not yet recruiting

Address

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

San Francisco, California, 94115

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610-878-4000

Center For Rheumatology, Fort Lauderdale, Florida

Status

Recruiting

Address

Center For Rheumatology

Fort Lauderdale, Florida, 33334

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610-878-4000

Omega Research Maitland, Orlando, Florida

Status

Recruiting

Address

Omega Research Maitland

Orlando, Florida, 32810

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610-878-4000

Tampa, Florida

Status

Recruiting

Address

University of South Florida (USF) - Carol and Frank Morsani Center for Advanced Health Care (CAHC)

Tampa, Florida, 33616

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610-878-4000

The University of Kansas Medical Center, Fairway, Kansas

Status

Not yet recruiting

Address

The University of Kansas Medical Center

Fairway, Kansas, 66205

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610-878-4000

Ochsner Clinic Foundation, Baton Rouge, Louisiana

Status

Recruiting

Address

Ochsner Clinic Foundation

Baton Rouge, Louisiana, 70809

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610-878-4000

University Of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University Of Michigan

Ann Arbor, Michigan, 48106

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610-878-4000

University of Missouri Health Care, Columbia, Missouri

Status

Not yet recruiting

Address

University of Missouri Health Care

Columbia, Missouri, 65212

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610-878-4000

Northwell Health Physicians, Great Neck, New York

Status

Recruiting

Address

Northwell Health Physicians

Great Neck, New York, 11021

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610-878-4000

Modern Clinic LLC, New York, New York

Status

Not yet recruiting

Address

Modern Clinic LLC

New York, New York, 10021

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610-878-4000

Paramount Medical Research & Consulting, Middleburg Heights, Ohio

Status

Recruiting

Address

Paramount Medical Research & Consulting

Middleburg Heights, Ohio, 44130

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610-878-4000

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

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610-878-4000

Wesley Neurology Clinic, Cordova, Tennessee

Status

Recruiting

Address

Wesley Neurology Clinic

Cordova, Tennessee, 38018

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610-878-4000

Houston, Texas

Status

Recruiting

Address

The University of Texas Medical School at Houston

Houston, Texas, 77030

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610-878-4000

Southwest Rheumatology Research, Mesquite, Texas

Status

Active, not recruiting

Address

Southwest Rheumatology Research

Mesquite, Texas, 75150

International Sites

Murdoch, Western Australia, Australia

Status

Recruiting

Address

The Perron Institute for Neurological and Translational Science

Murdoch, Western Australia, 6150

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610-878-4000

Ghent Universit Hospital (UZ Gent), Gent, Belgium

Status

Recruiting

Address

Ghent Universit Hospital (UZ Gent)

Gent, , 9000

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610-878-4000

Universitair Ziekenhuis (UZ) Leuven, Leuven, Belgium

Status

Not yet recruiting

Address

Universitair Ziekenhuis (UZ) Leuven

Leuven, , 3000

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610-878-4000

CHU de Liège - Sart Tilman, Liège, Belgium

Status

Recruiting

Address

CHU de Liège - Sart Tilman

Liège, , 4000

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610-878-4000

CHU De Dijon Hopital Du Bocage, Dijon, France

Status

Recruiting

Address

CHU De Dijon Hopital Du Bocage

Dijon, , 21079

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610-878-4000

CHU - Hospital de la Timone, Marseille, France

Status

Recruiting

Address

CHU - Hospital de la Timone

Marseille, , 13385

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610-878-4000

CHU Nice-Hopital Archet I, Nice, France

Status

Not yet recruiting

Address

CHU Nice-Hopital Archet I

Nice, , 06202

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Paris, France

Status

Recruiting

Address

CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix

Paris, , 75013

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610-878-4000

Hopitaux Universitaire de Strasbourg, Strasbourg, France

Status

Recruiting

Address

Hopitaux Universitaire de Strasbourg

Strasbourg, , 67098

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610-878-4000

Charité - Universitätsmedizin Berlin, Berlin, Germany

Status

Recruiting

Address

Charité - Universitätsmedizin Berlin

Berlin, , 10117

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610-878-4000

University Essen, Essen, Germany

Status

Recruiting

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University Essen

Essen, , 45147

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University Medicine Göttingen, Göttingen, Germany

Status

Not yet recruiting

Address

University Medicine Göttingen

Göttingen, , 37075

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610-878-4000

University Hospital Köln, Köln, Germany

Status

Recruiting

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University Hospital Köln

Köln, , 50937

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610-878-4000

University of Münster, Münster, Germany

Status

Recruiting

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University of Münster

Münster, , 48149

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610-878-4000

Brescia, Italy

Status

Recruiting

Address

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

Brescia, , 25123

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Universitaria Vittorio Emanuele, Catania, Italy

Status

Recruiting

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Universitaria Vittorio Emanuele

Catania, , 95124

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Universita degli Studi Firenze, Firenze, Italy

Status

Recruiting

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Universita degli Studi Firenze

Firenze, , 5134

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Azienda Ospedaliero Universitaria Pisana, Pisa, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Pisana

Pisa, , 56124

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610-878-4000

Roma, Italy

Status

Recruiting

Address

University of Sacred Heart Policlinico A. Gemelli

Roma, , 00168

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610-878-4000

Chukyo Hospital, Nagoya, Aichi, Japan

Status

Recruiting

Address

Chukyo Hospital

Nagoya, Aichi, 457-8510

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610-878-4000

University Of Fukui Hospital, Yoshida-Gun, Fukui, Japan

Status

Recruiting

Address

University Of Fukui Hospital

Yoshida-Gun, Fukui, 910-1193

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610-878-4000

Gunma University Hospital, Maebashi, Gunma, Japan

Status

Recruiting

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Gunma University Hospital

Maebashi, Gunma, 371-6511

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610-878-4000

Hokkaido University Hospital, Sapporo, Hokkaido, Japan

Status

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Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648

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610-878-4000

St. Marianna University Hospital, Kawasaki, Kanagawa, Japan

Status

Recruiting

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St. Marianna University Hospital

Kawasaki, Kanagawa, 216-8511

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610-878-4000

The University of Tokyo Hospital, Bunkyo-Ku, Tokyo, Japan

Status

Withdrawn

Address

The University of Tokyo Hospital

Bunkyo-Ku, Tokyo, 113-8655

Nippon Medical School Hospital, Bunkyō-Ku, Tokyo, Japan

Status

Recruiting

Address

Nippon Medical School Hospital

Bunkyō-Ku, Tokyo, 113-8603

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610-878-4000

Shinjuku-Ku, Tokyo, Japan

Status

Recruiting

Address

Tokyo Women's Medical University Hospital

Shinjuku-Ku, Tokyo, 162-8666

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610-878-4000

Tokyo, Japan

Status

Recruiting

Address

Tokyo Medical And Dental University Medical Hospital

Tokyo, , 113-8519

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610-878-4000

Wakayama Medical University Hospital, Wakayama, Japan

Status

Recruiting

Address

Wakayama Medical University Hospital

Wakayama, , 641-8509

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610-878-4000

Yamaguchi University Hospital, Yamaguchi, Japan

Status

Recruiting

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Yamaguchi University Hospital

Yamaguchi, , 755-8505

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610-878-4000

Mexico, Distrito Federal, Mexico

Status

Recruiting

Address

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

Mexico, Distrito Federal, 11850

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610-878-4000

Guadalajara, Jalisco, Mexico

Status

Recruiting

Address

Centro Integral en Reumatologia, SA de CV

Guadalajara, Jalisco, 44160

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610-878-4000

San Luis Potosí, Mexico

Status

Recruiting

Address

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

San Luis Potosí, , 78213

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610-878-4000

Specjalistyczne Gabinety Sp. z o.o, Krakow, Poland

Status

Recruiting

Address

Specjalistyczne Gabinety Sp. z o.o

Krakow, , 30-539

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clini[email protected]

610-878-4000

Lublin, Poland

Status

Recruiting

Address

Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr 2

Lublin, , 20-582

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610-878-4000

Centrum Medyczne Grunwald, Poznań, Poland

Status

Recruiting

Address

Centrum Medyczne Grunwald

Poznań, , 60-369

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610-878-4000

ORIS Firm Limited Liability Company, Moscow, Russian Federation

Status

Recruiting

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ORIS Firm Limited Liability Company

Moscow, , 117321

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610-878-4000

Municipal Medicoprophylactyc Institution, Nizhny Novgorod, Russian Federation

Status

Recruiting

Address

Municipal Medicoprophylactyc Institution

Nizhny Novgorod, , 603005

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610-878-4000

Medical Centre-Healthy Family, Novosibirsk, Russian Federation

Status

Recruiting

Address

Medical Centre-Healthy Family

Novosibirsk, , 630099

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610-878-4000

Saint Petersburg, Russian Federation

Status

Recruiting

Address

St. Petersburg City Rheumatological Hospital 25

Saint Petersburg, , 190068

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610-878-4000

Yaroslavl, Russian Federation

Status

Recruiting

Address

State Autonomous Healthcare Institution of Yaroslavl Oblast Clinical Hospital 3

Yaroslavl, , 150007

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610-878-4000

A Coruña, Spain

Status

Recruiting

Address

Complejo Hospitalario Universitario A Coruña

A Coruña, , 15006

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610-878-4000

Kantonsspital St. Gallen, Saint Gallen, Switzerland

Status

Recruiting

Address

Kantonsspital St. Gallen

Saint Gallen, , 9007

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610-878-4000

Cherkasy, Ukraine

Status

Recruiting

Address

Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, , 18009

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610-878-4000

Kharkiv, Ukraine

Status

Recruiting

Address

Mechnikov Institute of Microbiology and Immunology of NAMS of Ukraine Kharkiv City Multispecialty Hospital

Kharkiv, , 61029

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610-878-4000

Khmelnitskiy Regional Hospital, Khmelnytskyi, Ukraine

Status

Recruiting

Address

Khmelnitskiy Regional Hospital

Khmelnytskyi, , 29000

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610-878-4000

Kyiv Railway Clinical Hospital No.2, Kyiv, Ukraine

Status

Recruiting

Address

Kyiv Railway Clinical Hospital No.2

Kyiv, , 03049

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610-878-4000

Clinic of Modern Rheumatology, Kyiv, Ukraine

Status

Recruiting

Address

Clinic of Modern Rheumatology

Kyiv, , 04071

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610-878-4000

Modern Clinic LLC, Zaporizhia, Ukraine

Status

Recruiting

Address

Modern Clinic LLC

Zaporizhia, , 69005

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610-878-4000

Doncaster Royal Infirmary, Doncaster, United Kingdom

Status

Recruiting

Address

Doncaster Royal Infirmary

Doncaster, , DN2 5LT

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610-878-4000