Study on the Effects and Safety of Efgartigimod PH20 SC for Adults with Active Idiopathic Inflammatory Myopathy

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What is this study about?

This clinical trial is focused on studying a condition known as Idiopathic Inflammatory Myopathy (IIM), which is a group of diseases that cause muscle inflammation and weakness. The study is investigating a treatment called efgartigimod PH20 SC, which is given as a solution for injection. This treatment is being compared to a placebo, alongside standard care treatments that help manage the immune system.

The purpose of the study is to evaluate how well efgartigimod PH20 SC works in improving the symptoms of IIM, as well as to assess its safety and how well it is tolerated by participants. Participants in the study will receive either the investigational treatment or a placebo, and their progress will be monitored over a period of time to see if there are any improvements in their condition. The study will also look at how the body processes the treatment and whether it causes any immune reactions.

Throughout the study, participants will undergo various assessments to measure changes in muscle strength and overall disease activity. These assessments will help determine the effectiveness of the treatment in providing clinical improvement for those with active IIM. The study aims to provide valuable information on whether efgartigimod PH20 SC can be a beneficial treatment option for individuals with this condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of idiopathic inflammatory myopathy and active disease indicators.

A signed informed consent is required to participate.

2 initial assessment

An initial assessment is conducted to evaluate the current health status and confirm the diagnosis.

This may include laboratory tests, electromyography, skin rash evaluation, muscle biopsy, or MRI to confirm active inflammation.

3 randomization

Participants are randomly assigned to receive either the investigational drug efgartigimod PH20 SC or a placebo.

This process is double-blinded, meaning neither the participant nor the study team knows which treatment is being administered.

4 treatment administration

The treatment involves subcutaneous injections of efgartigimod PH20 SC or placebo.

The frequency and duration of the treatment are determined by the study protocol and are administered alongside standard immunomodulatory therapy.

5 monitoring and follow-up

Regular monitoring is conducted to assess the efficacy and safety of the treatment.

This includes evaluating improvement scores, muscle strength, and overall disease activity through various assessments.

6 completion of study

The study is estimated to conclude by August 2026.

Upon completion, participants may undergo a final assessment to evaluate the overall impact of the treatment.

Who Can Join the Study?

  • Must be able to understand and agree to participate in the study, and sign a consent form.
  • Must have a confirmed or likely diagnosis of idiopathic inflammatory myopathy (IIM), which is a type of muscle inflammation with an unknown cause.
  • Must have one of the following medical histories:
    • Dermatomyositis (DM) or juvenile dermatomyositis (JDM), with the disease starting before 18 years old. For JDM, the diagnosis should be within 5 years of the study screening date.
    • Polymyositis (PM), which may include antisynthetase syndrome (ASyS).
    • Immune-mediated necrotizing myopathy (IMNM).
  • Must have active disease, shown by at least one of the following:
    • Abnormal levels of certain enzymes in the blood, such as creatine kinase (CK), aldolase, lactate dehydrogenase, aspartate aminotransaminase (AST), or alanine aminotransferase (ALT).
    • Recent electromyography (a test that checks muscle health) showing active disease.
    • Active skin rash related to dermatomyositis (DM).
    • Muscle biopsy (a small sample of muscle tissue) from the past 3 months showing active IIM.
    • Recent magnetic resonance imaging (MRI) showing active inflammation.
  • Must have muscle weakness.
  • Must be receiving a treatment for IIM that is allowed in the study.
  • Must follow local rules for contraceptive use if applicable. Women who can become pregnant must have a negative pregnancy test before starting the study treatment.

Who Cannot Join the Study?

  • Patients with any other active autoimmune disease that might interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics or antiviral medications.
  • Patients who have received any other investigational drug within the last 30 days.
  • Patients with a history of severe allergic reactions to any of the study medications.
  • Patients who are pregnant or breastfeeding.
  • Patients with significant heart, liver, or kidney problems.
  • Patients with a history of cancer, except for certain types of skin cancer.
  • Patients who have received a live vaccine within the last 4 weeks.
  • Patients with a history of drug or alcohol abuse within the last year.
  • Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Medical University Of Vienna Vienna Austria
Medizinische Universitaet Innsbruck Innsbruck Austria
Azienda Ospedaliero Universitaria Careggi Florence Italy
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario Y Politecnico La Fe Valencia Spain
Universitaetsmedizin Goettingen Goettingen Germany
Pomeranian Medical University Szczecin Poland

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Centre Hospitalier Universitaire Rouen Rouen France
University Of Debrecen Debrecen Hungary
University General Hospital Of Ioannina Ioannina Greece
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Universita’ Degli Studi Di Verona Verona Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Centre hospitalier universitaire de Liege Liege Belgium
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitair Ziekenhuis Gent Gent Belgium
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hopital Beaujon Clichy France
Hospital Universitario 12 De Octubre Madrid Spain
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Connolly Hospital Dublin Ireland
Hospital Universitario Virgen De Valme Sevilla Spain
Medical Center Artmed Ltd. Plovdiv Bulgaria
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Eginitio Hospital Athens Greece
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Universita Cattolica Del Sacro Cuore Rome Italy
Hospital Edouard Herriot Lyon France
Roskilde University Roskilde Denmark
The Cyprus Foundation For Muscular Dystrophy Research Agios Dometios Cyprus
AZ Sint-Lucas & Volkskliniek Gent Belgium
Our Ladys Hospital Manorhamilton Sligo Ireland
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Narodny Ustav Reumatickych Chorob Piestany Slovakia
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Bari Italy
SPZOZ Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Łodzi Lodz Poland
Lzwif Gfixzmp Hytwidrj Of Auxfsc Athens Greece
Amwxaogqw Ulz Amsterdam The Netherlands
Ajziryz Ofgfxrpigdf Uugloflcqpnvn Cajxkbtaabvv Dbtlx Sipywq E Dcsjg Syecimn Dl Tggekb Turin Italy
Apppgx Mnaeqxd Cubhbh Sdeq Thessaloniki Greece
Hpgbqllr Dl Ls Skzsj Csga I Sapv Pos Barcelona Spain
Sv Vudcrrlzrnoaegf Uxbwnmqtpq Hxhqfjrk Dublin Ireland
Ubcgrqwolp Mqtguhw Cotlte Hxoitimojgymweywm Hamburg Germany
Fnqolafzq Pbsv Ld Ihjhicnuvrqag Bxopanhpd Dyl Hkdaajap Uzkrsxcigmwjz Lf Pvg Madrid Spain
Cgkdksry Htwtcayyemsc Ujtuwyuiyacni Dq Vebi Vigo Spain
Hyvngmio Uqupuijgbqnxyu Sbncqwpknk &ldvldh Hlqkhea do Hoyvjbovqnm STRASBOURG, Alsace France
Aieaevp Uxp Ibsrb Dd Rzuady Esjrhs Reggio Emilia Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.04.2022
Belgium Belgium
Not recruiting
01.04.2022
Bulgaria Bulgaria
Not recruiting
01.04.2022
Cyprus Cyprus
Not recruiting
01.04.2022
Czechia Czechia
Not recruiting
01.04.2022
Denmark Denmark
Not recruiting
01.04.2022
France France
Not recruiting
01.04.2022
Germany Germany
Not recruiting
01.04.2022
Greece Greece
Not recruiting
01.04.2022
Hungary Hungary
Not recruiting
01.04.2022
Ireland Ireland
Not recruiting
01.04.2022
Italy Italy
Not recruiting
01.04.2022
Lithuania Lithuania
Not recruiting
01.04.2022
Poland Poland
Not recruiting
01.04.2022
Portugal Portugal
Not recruiting
01.04.2022
Slovakia Slovakia
Not recruiting
01.04.2022
Spain Spain
Not recruiting
01.04.2022
Sweden Sweden
Not recruiting
01.04.2022
The Netherlands The Netherlands
Not recruiting
01.04.2022

Trial locations

Investigated Drugs:

Efgartigimod PH20 SC is a medication being studied for its potential to help people with active idiopathic inflammatory myopathy, a condition that causes muscle inflammation and weakness. This medication is designed to work by modulating the immune system, potentially reducing inflammation and improving muscle strength and function. The trial aims to assess how well this medication works, how safe it is, and how the body processes it.

Investigated Diseases:

Idiopathic Inflammatory Myopathy – This is a group of diseases characterized by chronic muscle inflammation and weakness. The exact cause is unknown, but it involves the immune system attacking the body’s own muscle tissues. Symptoms often include muscle pain, fatigue, and difficulty with movements such as climbing stairs or lifting objects. Over time, the muscle weakness can become more pronounced, affecting daily activities. The condition can vary in severity and may involve other organs, such as the skin or lungs. It is typically a long-term condition that requires ongoing management.

Trial ID:
2024-512785-33-00
Protocol code:
ARGX-113-2007
NCT ID:
NCT05523167
Trial Phase:
Therapeutic use (Phase IV)

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