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

Dermatomyositis Clinical Trial

— ALKIVIA+  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05979441
• Other study ID #: ARGX-113-2011
• Status: Recruiting
• Phase: Phase 3
• Start date: September 12, 2023
• Est. completion date: September 2027

Study information

• Verified date: April 2024
• Source: argenx
• Contact: Sabine Coppieters, MD
• Phone: 857-350-4834
• Email: Clinicaltrials[@]argenx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatomyositis
• Immune-Mediated Necrotizing Myopathy
• Muscular Diseases
• Myositis
• Polymyositis

Intervention

Biological:
• EFG PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer

Locations

Country	Name	City	State
Argentina	Centro Medico Privado de Reumatologia	San Miguel De Tucumán
Belgium	Universitair Ziekenhuis Leuven Gasthuisberg Campus	Leuven
Bulgaria	Medical Centre Artmed	Plovdiv
Denmark	Copenhagen University Hospital-Rigshospitalet University Hospital	Copenhagen
Georgia	Aversi Clinic	Tbilisi
Georgia	LLC MediClub Georgia	Tbilisi
Georgia	The First Medical Center	Tbilisi
Greece	National and Kapodistrian University of Athens - Eginition Hospital	Athens
Korea, Republic of	Seoul National University Hospital	Seoul
Lithuania	Santaros University Clinic	Vilnius
United States	Austin Neuromuscular Center (National Neuromuscular Research Institute, PLLC)	Austin	Texas
United States	Attune Health Research, Inc	Beverly Hills	California
United States	Nerve And Muscle Center Of Texas	Houston	Texas
United States	UCI Health - ALS and Neuromuscular Center - Neurology	Orange	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
argenx

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Bulgaria,  Denmark,  Georgia,  Greece,  Korea, Republic of,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence treatment-emergent adverse events and adverse event of special interest		Up to 60 weeks
Secondary	Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS)		Up to 52 weeks
Secondary	Prednisone dose reduction (average monthly dose)		Up to 52 weeks
Secondary	Proportion of participants who discontinue corticosteroids		Up to 52 weeks
Secondary	Total improvement score (TIS)	measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).	Up to 52 weeks
Secondary	Proportion of TIS responders (minimal, moderate, major)		up to 52 weeks
Secondary	Individual core set measures (CSMs) of the TIS	measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).	up to 52 weeks
Secondary	Percentage of participants with clinically inactive disease		up to 52 weeks
Secondary	Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks		up to 52 weeks

External Links

•   Study website