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Enrolling by invitation NCT05979441

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy

Phase III Interventional Myositis Active Idiopathic Inflammatory Myopathy Dermatomyositis Polymyositis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Efgartigimod PH20 SC.
Who it may be relevant to
Registry conditions: Myositis, Active Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Austria, Belgium, Bulgaria +24
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy

Overview

The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007. The study consists of a treatment period where participants will receive efgartigimod PH20 SC for up to 51 months. The treatment period will be followed by a treatment-free safety follow-up period of 56 days.

Interventions

  • Biological Efgartigimod PH20 SC
    Subcutaneous injection of Efgartigimod PH20 given by vials or prefilled syringe (PFS)

Primary outcome measures

  • Incidence of AEs, SAEs and AESIs over time [Time frame: Up to 53 months]
Secondary outcome measures (12)
  • C-GTI comprising the AIS over time [Time frame: Up to 51 months]
  • C-GTI comprising the CWS over time [Time frame: Up to 51 months]
  • C-GTI comprising the GTI-MD over time [Time frame: Up to 51 months]
  • Prednisone dose reduction (average monthly dose) over time [Time frame: Up to 51 months]
  • TIS over time [Time frame: Up to 51 months]
  • Proportion of TIS responders (minimal, moderate, major) over time [Time frame: Up to 51 months]
  • Individual CSMs of the TIS over time [Time frame: Up to 51 months]
  • Percentage of participants with clinically inactive disease [Time frame: Up to 51 months]
  • Percentage of participants with remission during the study [Time frame: Up to 51 months]
  • PGI-S over time [Time frame: Up to 51 months]
  • CGI-S over time [Time frame: Up to 51 months]
  • Physical Functioning subscale and Physical Component Summary scores of the SF-36v2 over time [Time frame: Up to 51 months]

Eligibility criteria

Inclusion criteria

  • Has completed trial ARGX-113-2007
  • Being capable of providing signed informed consent and complying with protocol requirements
  • Agrees to use contraceptive measures consistent with local regulations and women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the study drug

Exclusion criteria

  • Intention to have major surgery during the study period or any other medical condition that has arisen since enrollment in study ARGX-113-2007, that in the investigator's opinion, would confound the results of the study or put the participant at undue risk
  • Known hypersensitivity reaction to the study drug or 1 of its excipients
  • Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 18 centers
  • Neuromuscular Clinical and Research Center - Neurology — Phoenix
  • Attune Health Research, Inc — Beverly Hills
  • UCI Health - ALS and Neuromuscular Center - Neurology — Orange
  • UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology — San Francisco
  • Yale Cancer Center-Yale University School Of Medicine — New Haven
  • UF Health - Rheumatology Medical Specialties Medical Plaza — Gainesville
  • Mayo Clinic - Florida - Neurology — Jacksonville
  • University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Cen — Tampa
  • … and 10 more centers
China · 9 centers
  • Nanfang Hospital, Southern Medical University — Guangzhou
  • Nanjing University Medical School - Taikang Xianlin Drum Tower Hospital (Nanjing Drum Towe — Nanjing
  • Peking University Third Hospital — Beijing
  • Peking Union Medical College Hospital — Beijing
  • Sichuan Provincial Academy of Medical Sciences and Sichuan Provincial People's Hospital — Chengdu
  • Shanghai Jiao Tong University School of Medicine - Renji Hospital - Shanghai Institute of — Shanghai
  • Huashan Hospital Affiliated to Fudan University — Shanghai
  • China Medical University (CMU) - First Affiliated Hospital — Shenyang
  • … and 1 more center
Italy · 7 centers
  • Azienda Ospedaliero Universitaria Consorziale Policlinico — Bari
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospit — Milan
  • Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara - Rheumatology — Pisa
  • Ospedale Sant'Andrea Hospital — Roma
  • Fondazione Policlinico Universitario Agostino Gemelli - Neurology — Roma
  • IRCCS Istituto Clinico Humanitas — Rozzano
  • Azienda sanitaria universitaria Friuli Centrale - ASUFC — Udine
Germany · 6 centers
  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Rheumatology — Berlin
  • Universitaetsklinikum Hamburg-Eppendorf — Hamburg
  • Rheumazentrum Ruhrgebiet — Herne
  • Universitatsmedizin Mannheim GmbH — Mannheim
  • Universitaetsklinikum Tuebingen (UKT) — Tübingen
  • Klinikum der Universitaet Ulm — Ulm
Japan · 6 centers
  • Juntendo University Hospital — Bunkyō City
  • The University of Tokyo Hospital — Bunkyō City
  • Japan Community Healthcare Organization Chukyo Hospital — Nagoya
  • Institute of Science Tokyo Hospital — Tokyo
  • Wakayama Medical University Hospital — Wakayama
  • Yamaguchi University Hospital — Yamaguchi
Thailand · 5 centers

Center list to be confirmed — check the primary protocol.

Georgia · 4 centers
  • Aversi Clinic — Tbilisi
  • LLC MediClub Georgia — Tbilisi
  • New Hospitals — Tbilisi
  • The First Medical Center — Tbilisi
Argentina · 3 centers
  • Framingham Centro Medico — La Plata
  • Centro Dermatologico Schejtman — San Miguel
  • Centro Medico Privado de Reumatologia — San Miguel de Tucumán
Greece · 3 centers
  • National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Me — Athens
  • National and Kapodistrian University of Athens - Eginition Hospital — Athens
  • ATTIKON University General Hospital - Neurology — Athens
Peru · 3 centers
  • Clinica San Juan de Dios - sede Arequipa - Rheumatology — Arequipa
  • Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima,Centro De Investigacion Iph — Lima
  • Investigaciones Clinicas S.A.C. — Lima
Spain · 3 centers
  • Hospital de la Santa Creu i Sant Pau — Barcelona
  • Hospital Universitario 12 de Octubre — Madrid
  • … and 1 more center
United Kingdom · 3 centers

Center list to be confirmed — check the primary protocol.

Belgium · 2 centers
  • AZ Sint-Lucas - Campus Sint-Lucas - Neurology — Ghent
  • Universitair Ziekenhuis Leuven Gasthuisberg Campus — Leuven
Bulgaria · 2 centers
  • Medical Centre Artmed — Plovdiv
  • Multiprofile hospital for active treatment Kaspela EOOD — Plovdiv
Poland · 2 centers
  • USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113 - Rheumatology — Lodz
  • Centrum Wsparcia Badan Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie (CWBK — Szczecin
Serbia · 2 centers
  • Clinical Center of Serbia — Belgrade
  • Institute of Rheumatology — Belgrade
Taiwan · 2 centers

Center list to be confirmed — check the primary protocol.

Austria · 1 center
  • Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck - Neurology — Innsbruck
Cyprus · 1 center
  • Cyprus Institute of Neurology and Genetics — Nicosia
Czechia · 1 center
  • Revmatologicky Ustav — Prague
Denmark · 1 center
  • Copenhagen University Hospital-Rigshospitalet University Hospital — Copenhagen
France · 1 center
  • Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetrier — Paris
Ireland · 1 center
  • University College Dublin (UCD) - St. Vincent's University Hospital (SVUH) — Dublin
Lithuania · 1 center
  • Santaros University Clinic — Vilnius
Mexico · 1 center
  • Hospital Angeles Clinica Londres — Mexico City
Netherlands · 1 center
  • Amsterdam UMC Research BV — Amsterdam
Portugal · 1 center
  • Centro Hospitalar do Porto - Hospital Santo Antonio — Porto
South Korea · 1 center
  • Seoul National University Hospital — Seoul
Sweden · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05979441 · ARGX-113-2011 · 2022-502851-79-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗