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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
argenx
Study ID
NCT05979441
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Active Idiopathic Inflammatory Myopathy
  • Antisynthetase Syndrome
  • Dermatomyositis
  • Immune-Mediated Necrotizing Myopathy
  • Myositis
  • Polymyositis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 12, 2023
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod PH20 SC
    Participants receiving efgartigimod PH20 subcutaneously

Primary Outcome Measure

Incidence of AEs, SAEs and AESIs over time [ Time Frame: Up to 53 months ]

Locations (18)

FacilityCityStateZIPSite coordinators
Neuromuscular Clinical and Research Center - NeurologyPhoenixArizona85028-
Attune Health Research, IncBeverly HillsCalifornia90039-
UCI Health - ALS and Neuromuscular Center - NeurologyOrangeCalifornia92868-
UCSF Health - ALS and Neurodegenerative Disease Center - DermatologySan FranciscoCalifornia94143-
Yale Cancer Center-Yale University School Of MedicineNew HavenConnecticut06520-
UF Health - Rheumatology Medical Specialties Medical PlazaGainesvilleFlorida32610-
Mayo Clinic - Florida - NeurologyJacksonvilleFlorida32224-
University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)TampaFlorida33616-
Emory Healthcare - Emory Clinic - RheumatologyAtlantaGeorgia30322-
Northwestern Medicine - Northwestern Memorial HospitalChicagoIllinois60611-
John Hopkins Medicine - Johns Hopkins Myositis CenterBaltimoreMaryland21224-2734-
Northwell Health Physician Partners RheumatologyGreat NeckNew York11021-
University of North Carolina (UNC) School of MedicineChapel HillNorth Carolina27514-
The Ohio State UniversityColumbusOhio43201-
Oregon Health and Science UniversityPortlandOregon97239-
University of Pittsburgh Medical CenterPittsburghPennsylvania15261-
Austin Neuromuscular Center (National Neuromuscular Research Institute, PLLC)AustinTexas78759-
Nerve And Muscle Center Of TexasHoustonTexas77030-

Find similar trials in Phoenix, AZ

By research site
Neuromuscular Clinical and Research Center - Neurology· Phoenix, AZAttune Health Research, Inc· Beverly Hills, CAUCI Health - ALS and Neuromuscular Center - Neurology· Orange, CAUCSF Health - ALS and Neurodegenerative Disease Center - Dermatology· San Francisco, CAYale Cancer Center-Yale University School Of Medicine· New Haven, CTUF Health - Rheumatology Medical Specialties Medical Plaza· Gainesville, FL

Related Studies