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Hizentra shows promise for rare muscle and skin disease

NCT ID NCT04044690

Disease control Sponsor: CSL Behring Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a medicine called Hizentra (IgPro20) in 134 adults with dermatomyositis, a rare disease causing muscle weakness and skin rashes. The goal was to see if weekly shots under the skin could improve symptoms better than a placebo. The study was stopped early, but results suggest Hizentra may help control the disease, though ongoing treatment is likely needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

134 people

The number who actually took part.

Started

Oct 2019

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

dermatomyositis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dermatomyositis

Contacts and locations

Locations

  • 0320077 - Centro Medico Privado de Reumatolgia

    San Miguel de Tucumán, T4000, Argentina

  • 0320081 - Fundacion Respirar

    Buenos Aires, C1426ABP, Argentina

  • 0320083 - Hospital Italiano de Buenos Aires

    Ciudad Autónoma Buenos Aires, Buenos Aires, C1181ACH, Argentina

  • 0320084 - DIM Clinica Privada

    Buenos Aires, B1704ETD, Argentina

  • 0560048 - Universitair Ziekenhuis (UZ) Leuven

    Leuven, 3000, Belgium

  • 0560049 - CHU de Liège - Sart Tilman

    Liège, 4000, Belgium

  • 0560050 - Ghent Universit Hospital (UZ Gent)

    Ghent, 9000, Belgium

  • 0560056 - Universitair Ziekenhuis Leuven

    Leuven, 3000, Belgium

  • 2500132 - Hopital Pitie-Salpetriere

    Paris, 75013, France

  • 2500133 - CHU - Hospital de la Timone

    Marseille, 13385, France

  • 2500135 - CHU Nice-Hopital Archet I

    Nice, 06202, France

  • 2500144 - Hopitaux Universitaire de Strasbourg

    Strasbourg, 67098, France

  • 2500146 - CHU De Dijon Hopital Du Bocage

    Dijon, 21079, France

  • 2500188 - Centre Hospitalier Regional Universitaire de Lille

    Lille, 59037, France

  • 2760036 - University Medicine Göttingen

    Göttingen, 37075, Germany

  • 2760199 - University Hospital Köln

    Cologne, 50937, Germany

  • 2760201 - Medizinische Hochschule Hannover (MHH)

    Hanover, 30625, Germany

  • 2760203 - Charité

    Berlin, 10117, Germany

  • 2760210 - University of Münster

    Münster, 48149, Germany

  • 2760211 - Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • 2760212 - University Hospital Of Tuebingen

    Tübingen, 72076, Germany

  • 2760268 - University of Ulm

    Ulm, 89081, Germany

  • 2760271 - Universitatsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307, Germany

  • 2760273 - Hautklinik des Uni-Klinikums Erlangen

    Erlangen, 91504, Germany

  • 3480048 - University of Debrecen

    Debrecen, 4032, Hungary

  • 3800132 - Universitaria Vittorio Emanuele

    Catania, 95124, Italy

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

    Brescia, 25123, Italy

  • 3800134 - Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124, Italy

  • 3800139 - Universita degli Studi Firenze

    Florence, 50134, Italy

  • 3920035 - Yamaguchi University Hospital

    Yamaguchi, 755-8505, Japan

  • 3920086 - St. Marianna University Hospital

    Kawasaki, Kanagawa, 216-8511, Japan

  • 3920087 - Wakayama Medical University Hospital

    Wakayama, 641-8509, Japan

  • 3920088 - Gunma University Hospital

    Maebashi, Gunma, 371-6511, Japan

  • 3920089 - Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • 3920090 - University Of Fukui Hospital

    Yoshida-Gun, Fukui, 910-1193, Japan

  • 3920091 - Nippon Medical School Hospital

    Bunkyō-Ku, Tokyo, 113-8603, Japan

  • 3920096 - Chukyo Hospital

    Nagoya, Aichi-ken, 457-8510, Japan

  • 3920097 - Tokyo Women's Medical University Hospital

    Shinjuku-Ku, Tokyo, 162-8666, Japan

  • 3920125 - Tokyo Medical And Dental University Medical Hospital

    Bunkyo, Tokyo, 113-8519, Japan

  • 4840081 - Centro Integral en Reumatologia, SA de CV

    Guadalajara, Jalisco, 44160, Mexico

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

    Mexico City, Mexico City, 11850, Mexico

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

    San Luis Potosí City, 78213, Mexico

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

    Lublin, 20-582, Poland

  • 6160117 - MedicalConcierge Centrum Medyczne

    Warsaw, 02-798, Poland

  • 6430120 - St. Petersburg City Rheumatological Hospital 25

    Saint Petersburg, 190068, Russia

  • 6430122 - City Clinical Hospital No. 5

    Nizhny Novgorod, 603005, Russia

  • 6430123 - Yaroslavl Oblast Clinical Hospital

    Yaroslavl, 150007, Russia

  • 6430124 - ORIS Firm Limited Liability Company

    Moscow, 117321, Russia

  • 6430125 - Medical Centre-Healthy Family

    Novosibirsk, 630099, Russia

  • 7240011 - Hospital Universitario Valle de Hebron

    Barcelona, 08035, Spain

  • 7240086 - Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006, Spain

  • 7240112 - Hospital Clinic Barcelona

    Barcelona, 08036, Spain

  • 7560028 - Kantonsspital St. Gallen

    Sankt Gallen, 9007, Switzerland

  • 7560033 - University Hospital Bern Inselspital

    Bern, 3010, Switzerland

  • 8040051 - Kyiv Railway Clinical Hospital No.2

    Kyiv, 03049, Ukraine

  • 8040052 - Institute of Rheumatology

    Kyiv, 02081, Ukraine

  • 8040053 - Cherkassy Regional Hospital

    Cherkasy, 18009, Ukraine

  • 8040054 - Modern Clinic LLC

    Zaporizhia, 69005, Ukraine

  • 8040055 - Mechnikov Institute of Microbiology and Immunology

    Kharkiv, 61029, Ukraine

  • 8040057 - Khmelnitskiy Regional Hospital

    Khmelnytskyi, 29000, Ukraine

  • 8040058 - State Institution National Scientific Center Strazhesko

    Kiev, 03151, Ukraine

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

    Tampa, Florida, 33616, United States

  • 8401115 - The University of Texas Medical School at Houston

    Houston, Texas, 77030, United States

  • 8401117 - Arizona Arthritis & Rheumatology Research

    Glendale, Arizona, 85306, United States

  • 8401129 - UCLA - Rheumatology Los Angeles

    Los Angeles, California, 90095, United States

  • 8401132 - Omega Research Maitland

    Orlando, Florida, 32810, United States

  • 8401151 - Biomedical Science Tower

    Pittsburgh, Pennsylvania, 15261, United States

  • 8401152 - The University of Kansas Medical Center

    Fairway, Kansas, 66205, United States

  • 8401160 - Center For Rheumatology

    Fort Lauderdale, Florida, 33334, United States

  • 8401199 - Neuromuscular Research Center

    Phoenix, Arizona, 85028, United States

  • 8401210 - University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • 8401473 - RecioMed Clinical Research Network, Inc.

    Boynton Beach, Florida, 33472, United States

  • 8401474 - West Tennessee Research Institute, LLC

    Jackson, Tennessee, 38305, United States

  • 8401476 - DS Research

    Louisville, Kentucky, 40241, United States

  • 8401486 - Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • 8401487 - Ohio State University

    Columbus, Ohio, 43210, United States

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Other studies related to the condition(s) this trial covers.