Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05979441 | ENROLLING BY INVITATION | Myositis

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

argenx

Brief Summary:

The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM who previously participated in ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.

Condition or disease

Myositis

Active Idiopathic Inflammatory Myopathy

Dermatomyositis

Polymyositis

Immune-Mediated Necrotizing Myopathy

Contrast

Intervention/treatment

EFG PH20 SC

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-09-12
Estimated Primary Completion Date : 2027-09
Estimated Study Completion Date : 2027-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 investigational medicinal product
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 investigational medicinal product or 1 of its excipients Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness
  • * Permanent discontinuation of IMP in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit
  • * Diagnosis with a deselected subtype of myositis based on the analysis of the phase 2 stage data in ARGX-113-2007, unless the investigator determines that the participant is benefiting from IMP as defined by a score of "much better" or "moderately better" on the 'Clinical Global Impression of Change' and 'Patient Global
  • * Impression of Change' assessments for at least 12 weeks, and that enrolling in the study is in the participant's best interest
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults with Active Idiopathic Inflammatory Myopathy

Location Details

NCT05979441

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Arizona

Neuromuscular Clinical and Research Center - Neurology

Phoenix, Arizona, United States, 85028

Not yet recruiting

United States, California

Attune Health Research, Inc

Beverly Hills, California, United States, 90039

Not yet recruiting

United States, California

UCI Health - ALS and Neuromuscular Center - Neurology

Orange, California, United States, 92868

Not yet recruiting

United States, California

UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology

San Francisco, California, United States, 94143

Not yet recruiting

United States, Florida

UF Health - Rheumatology Medical Specialties Medical Plaza

Gainesville, Florida, United States, 32610

Not yet recruiting

United States, Florida

Mayo Clinic - Florida - Neurology

Jacksonville, Florida, United States, 32224

Not yet recruiting

United States, Georgia

Emory Healthcare - Emory Clinic - Rheumatology

Atlanta, Georgia, United States, 30322

Not yet recruiting

United States, Illinois

Northwestern Medicine - Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Not yet recruiting

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15261

Not yet recruiting

United States, Texas

Austin Neuromuscular Center (National Neuromuscular Research Institute, PLLC)

Austin, Texas, United States, 78759

Not yet recruiting

United States, Texas

Nerve And Muscle Center Of Texas

Houston, Texas, United States, 77030

Not yet recruiting

Argentina,

Private Rheumatology Medical Center

San Miguel de Tucumán, Argentina, 4000

Not yet recruiting

Argentina,

Schejtman dermatological center

San Miguel, Argentina, B1663GKT

Not yet recruiting

Austria,

Tirol Kliniken - A.O. State Hospital Innsbruck - Neurology

Innsbruck, Austria, 6020

Not yet recruiting

Belgium,

AZ Sint-Lucas - Campus Sint-Lucas - Neurology

Gent, Belgium, 9000

Not yet recruiting

Belgium,

University Hospital Leuven Gasthuisberg Campus

Leuven, Belgium, 3000

Not yet recruiting

Bulgaria,

Medical Center Artmed

Plovdiv, Bulgaria, 4002

Not yet recruiting

Cyprus,

Cyprus Institute of Neurology and Genetics

Nicosia, Cyprus, 2371

Not yet recruiting

Czechia,

Rheumatological charter

Prague, Czechia, 12850

Not yet recruiting

Denmark,

Copenhagen University Hospital-Rig Hospital University Hospital

Copenhagen, Denmark, 2100

Not yet recruiting

France,

Reference Center Neuro-Muscular Diseases-CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix

Paris, France, 75013

Not yet recruiting

Georgia,

Having them clinic

Tbilisi, Georgia, 0160

Not yet recruiting

Georgia,

LLC Mediclub Georgia

Tbilisi, Georgia, 0160

Not yet recruiting

Georgia,

New Hospitals

Tbilisi, Georgia, 0162

Not yet recruiting

Georgia,

The First Medical Center

Tbilisi, Georgia, 0180

Not yet recruiting

Germany,

Charite Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Rheumatology

Berlin, Germany, 10117

Not yet recruiting

Germany,

Universitaetskinic tuebingen (UKT)

Tue, Germany, 72076

Not yet recruiting

Greece,

National and Kapodistrian University of Athens - Eginition Hospital

Athens, Greece, 115 28

Not yet recruiting

Greece,

ATTIKON University General Hospital - Neurology

Athens, Greece, 12462

Not yet recruiting

Italy,

Institute of scientific hospitalization and care (IRCCS) - San Raffaele Hospital Hospital

Milan, Italy, 20132

Not yet recruiting

Italy,

Pisan University Hospital - Santa Chiara Hospital - Rheumatology

Pisa, Italy, 56126

Not yet recruiting

Italy,

Agostino Gemelli Polyclinic University Foundation - Neurology

Roma, Italy, 168

Not yet recruiting

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Not yet recruiting

Lithuania,

Santara University Clinic

Vilnius, Lithuania, 08410

Not yet recruiting

Peru,

CLINICA SAN JUAN DE DIOS - AREQUIPA HEADQUARTERS - RHEUMATOLOGY

Arequipa, Peru, 4000

Not yet recruiting

Poland,

Clinical Research Center of the Pomeranian Medical University of Szczecin (CWBK PUM) - Rheumatology

Szczecin, Poland, 71-252

Not yet recruiting

Poland,

WSK -Wam Central Veteran Hospital - Clinical Hospital ul. Zeromskiego 113 - Rheumatology

Łódź, Poland, 90-549

Not yet recruiting

Spain,

University Hospital I Politecnic La Fe de Valencia - Neurology

Valencia, Spain, 46026

Not yet recruiting

Sweden,

Karolinska University Hospital Solna

Solna, Sweden, 17176

Not yet recruiting

Taiwan,

Chung Shan Medical University Hospital

Taichung City, Taiwan, 402

Not yet recruiting

Thailand,

King Chulalongkorn Memorial Hospital - Neurology

Bangkok, Thailand, 10330

Not yet recruiting

Thailand,

Phramongkutklao Hospital

Bangkok, Thailand, 10400

Not yet recruiting

Thailand,

Faculty Of Medicine, Khon Kaen University

Khon kaen, Thailand, 40002

Not yet recruiting

United Kingdom,

Northern Care Allicance NHS Foundation Trust - Salford Royal - Rheumatology

Salford, United Kingdom, M6 8HD