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

April 5, 2024 updated by: argenx

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • San Miguel De Tucumán, Argentina, 4000
        • Recruiting
        • Centro Medico Privado de Reumatologia
        • Contact:
  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Universitair Ziekenhuis Leuven Gasthuisberg Campus
        • Contact:
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • Medical Centre Artmed
        • Contact:
  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Copenhagen University Hospital-Rigshospitalet University Hospital
        • Contact:
  • Georgia
      • Tbilisi, Georgia, 0160
      • Tbilisi, Georgia, 0180
        • Recruiting
        • The First Medical Center
        • Contact:
      • Tbilisi, Georgia, 0160
        • Recruiting
        • LLC MediClub Georgia
        • Contact:
  • Greece
      • Athens, Greece, 115 28
        • Recruiting
        • National and Kapodistrian University of Athens - Eginition Hospital
        • Contact:
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
  • Lithuania
      • Vilnius, Lithuania, 08410
        • Recruiting
        • Santaros University Clinic
        • Contact:
  • United States
    • California
      • Beverly Hills, California, United States, 90039
        • Recruiting
        • Attune Health Research, Inc
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • UCI Health - ALS and Neuromuscular Center - Neurology
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • Austin Neuromuscular Center (National Neuromuscular Research Institute, PLLC)
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Nerve and Muscle Center of Texas
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence treatment-emergent adverse events and adverse event of special interest
Time Frame: Up to 60 weeks
Up to 60 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-113-2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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