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

Study acronym: ALKIVIA+
StatusEnrolling by Invitation
PhasePhase 3
Sponsorargenx
Started2023-09-12
View on ClinicalTrials.gov ↗

Amendment history

2026-07-20
Study Status, Contacts/Locations v26
Study sites90→92
2026-06-11
Study Status, Contacts/Locations v25
Study sites88→90
2026-06-02
Study Status v24
Re-verified, no change to tracked fields
2026-05-27
Study Status, Contacts/Locations v23
Study sites87→88
2026-05-26
Study Status, Contacts/Locations v22
Study sites86→87
2026-04-22
Study Status, Contacts/Locations v21
Trial sites expanded: 80 → 86 locations
2026-03-09
Study Status, Contacts/Locations v20
Study sites78→80
2026-02-06
Study Status, Contacts/Locations v19
Study sites73→78
2026-01-07
Study Status, Contacts/Locations v18
Study sites69→73
2025-12-03
Study Status, Oversight, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v17
Primary completion date2027-09→2028-09
Completion date2027-09→2028-09
Study sites58→69
InterventionsEFG PH20 SC (Biological)→Efgartigimod PH20 SC (Biological)
Eligibility criteria-610 characters
[...] ative urine pregnancy test at baseline before receiving the investigationalstudy medicinal productdrug Exclusion Criteria: Intention to have major surgery during the study period; or any other medical condition that has arisen since enroll [...] articipant at undue risk Known hypersensitivity reaction to investigationalthe medicinalstudy productdrug or 1 of its excipients Development of any malignancy, eithe [...] 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 [...]
Secondary endpoints8 to 21 entries
Composite Glucocorticoid Toxicity Index (C-GTI) comprising the AggregateAIS Improvementover Scoretime C-GTI (AIS) andcomprising the CumulativeCWS Worseningover Scoretime C-GTI (CWS)comprising the GTI-MD over time Prednisone dose reduction (average monthly dose) over time ProportionTIS ofover participants who discontinue corticosteroids Total improvement score (TIS)time Proportion of TIS responders (minimal, moderate, major) over time Individual core set measures (CSMs) of the TIS over time Percentage of participants with remission, definedduring asthe astudy PGI-S clinicallyover inactivetime C [...] [...]
Primary endpoints1 entry, revised
Incidence treatment-emergentof adverseAEs, eventsSAEs and adverseAESIs eventover of special interesttime
2025-08-27
Study Status, Contacts/Locations v16
Study sites55→58
2025-07-16
Study Status, Contacts/Locations v15
Study sites51→55
2025-05-19
Study Identification, Study Status, Contacts/Locations v14
Study sites44→51
Study titlerevised
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults withWith Active Idiopathic Inflammatory Myopathy
2024-12-09
Study Identification, Study Status v13
Re-verified, no change to tracked fields
2024-11-06
Study Status, Contacts/Locations v12
Study sites43→44
2024-10-08
Study Identification, Study Status, Oversight, Contacts/Locations v11
Study sites35→43
Study titlerevised
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults Withwith Active Idiopathic Inflammatory Myopathy
2024-07-09
Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v10
Trial statusRecruiting→Enrolling by Invitation
Study sites28→35
2024-05-17
Study Status, Contacts/Locations v9
Study sites15→28
2024-04-05
Study Status, Contacts/Locations v8
Study sites14→15
2024-03-13
Study Status, Contacts/Locations v7
Study sites12→14
2024-02-06
Study Status, Contacts/Locations v6
Study sites11→12
2024-01-16
Study Status, Conditions, Contacts/Locations v5
Study sitescontacts updated at 11 of 11 sites
2024-01-03
Study Status, Contacts/Locations v4
Study sites16→11
2023-11-22
Study Status, Contacts/Locations v3
Study sites13→16
2023-10-17
Study Status, Contacts/Locations v2
Study sites12→13
2023-10-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-09→confirmed 2023-09-12
Study sites0→12
2023-07-28
Original filing
Argenx
56 trials monitored
See 2 trials at risk
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.
Trial Details
NCT Number NCT05979441
Lead Sponsor argenx
Conditions Myositis, Active Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis, Immune-Mediated Necrotizing Myopathy, Antisynthetase Syndrome
Enrollment 240 participants
Start Date 2023-09-12
Primary Completion 2028-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-21