2022-502851-79-00
Recruiting
Phase 3
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
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Argenx
- Enrollment
- 80
- Locations
- 67
- Primary Endpoint
- Incidence and severity of treatment-emergent adverse events (TEAEs), adverse event(s) of special interests (AESIs,) and serious adverse events (SAEs) by System Organ Class (SOC) and Preferred Term (PT) over time
Overview
Brief Summary
To assess the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Open-label Extension of Study ARGX-113-2007
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Has completed ARGX-113-2007
- •Is capable of providing signed informed consent and complying with protocol requirements
- •Agrees to use contraceptive measures consistent with local regulations and the following: • women of childbearing potential (WOCBP) must have a negative urine pregnancy test at baseline before receiving investigational medicinal product (IMP).
Exclusion Criteria
- •Intention to have major surgery during the ARGX-113-2011 study period; or any other medical condition that has arisen since enrollment in 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 to investigational medicinal product (IMP) 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 investigational medicinal product (IMP) in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit.
Outcomes
Primary Outcomes
Incidence and severity of treatment-emergent adverse events (TEAEs), adverse event(s) of special interests (AESIs,) and serious adverse events (SAEs) by System Organ Class (SOC) and Preferred Term (PT) over time
Incidence and severity of treatment-emergent adverse events (TEAEs), adverse event(s) of special interests (AESIs,) and serious adverse events (SAEs) by System Organ Class (SOC) and Preferred Term (PT) over time
Changes and abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters over time
Changes and abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters over time
Secondary Outcomes
- Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS) over time
- Prednisone dose reduction (average monthly dose) over time
- Total improvement score (TIS) over time
- Proportion of TIS responders (minimal, moderate, major) over time
- Individual core set measure (CSMs) of the TIS over time
- Percentage of participants with clinically inactive disease, defined as no evidence of disease activity, based on an Physician Global Assessment of Disease Activity (MDGA) and Extramuscular Global Assessment of the Myositis Disease Activity Assessment Tool (MDAAT) of 0 and normal creatine kinase (CK) values for at least 12 weeks (at week 28 and every 24 weeks thereafter)
- Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks, during the study
Investigators
Regulatory
Scientific
Argenx
Study Sites (67)
Loading locations...
Similar Trials
Recruiting
Phase 2
A study to assess the long-term safety and efficacy of a subcutaneous
formulation of efgartigimod in adults with chronic inflammatory
demyelinating polyneuropathy (an autoimmune disorder that affects the
peripheral nerves)2023-507885-21-00Argenx88
Active, not recruiting
Phase 3
一项在活动性特发性炎性肌病成人受试者中探究 efgartigimod PH20 SC 有效性和安全性的研究CTR2025471130
Recruiting
Not Applicable
Real-World Efgartigimod Effectiveness in CIDP: A Prospective StudyNCT07264426argenx200
Enrolling By Invitation
Phase 3
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory MyopathyMyositisActive Idiopathic Inflammatory MyopathyDermatomyositisPolymyositisImmune-Mediated Necrotizing MyopathyAntisynthetase SyndromeNCT05979441argenx240
Not yet recruiting
Phase 1/2
Study of ART6043 in Advanced/Metastatic Solid Tumors Patients2023-509220-17-00Artios Pharma Limited55