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

argenx

Status and phase: Invitation-only; Phase 3

Conditions: Dermatomyositis; Myositis; Polymyositis; Immune-Mediated Necrotizing Myopathy; Antisynthetase Syndrome; Active Idiopathic Inflammatory Myopathy

Treatments: Biological: EFG PH20 SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT05979441

ARGX-113-2011

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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240 participants in 1 patient group

EFG PH20 SC

Experimental group

Description:

participants receiving efgartigimod PH20 SC on top of background treatment

Treatment:

Biological: EFG PH20 SC