ALKIVIA+: A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EFG PH20 SC participants receiving efgartigimod PH20 SC on top of background treatment |
Biological: EFG PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
|
Outcome Measures
Primary Outcome Measures
- Incidence treatment-emergent adverse events and adverse event of special interest [Up to 60 weeks]
Secondary Outcome Measures
- Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS) [Up to 52 weeks]
- Prednisone dose reduction (average monthly dose) [Up to 52 weeks]
- Proportion of participants who discontinue corticosteroids [Up to 52 weeks]
- Total improvement score (TIS) [Up to 52 weeks]
measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
- Proportion of TIS responders (minimal, moderate, major) [up to 52 weeks]
- Individual core set measures (CSMs) of the TIS [up to 52 weeks]
measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
- Percentage of participants with clinically inactive disease [up to 52 weeks]
- Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks [up to 52 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Has completed trial ARGX-113-2007
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Being capable of providing signed informed consent and complying with protocol requirements
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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:
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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
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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
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Permanent discontinuation of IMP in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- argenx
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ARGX-113-2011