search
Back to results

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

Primary Purpose

Myositis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
EFG PH20 SC
Sponsored by
argenx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Investigator site US0010127Recruiting
  • Investigator site US0010161Recruiting
  • Investigator site BG3590019Recruiting
  • Investigator site CZ4200011Recruiting
  • Investigator site DK0450007Recruiting
  • Investigator site ES0340047Recruiting
  • Investigator site ES0340054Recruiting
  • Investigator site ES0340048Recruiting
  • Investigator site ES0340049Recruiting
  • Investigator site ES0340060Recruiting
  • Investigator site ES0340042Recruiting
  • Investigator site ES0340039Recruiting
  • Investigator site ES0340046Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EFG PH20 SC

Arm Description

participants receiving efgartigimod PH20 SC on top of background treatment

Outcomes

Primary Outcome Measures

Incidence treatment-emergent adverse events and adverse event of special interest

Secondary Outcome Measures

Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS)
Prednisone dose reduction (average monthly dose)
Proportion of participants who discontinue corticosteroids
Total improvement score (TIS)
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)
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).
Percentage of participants with clinically inactive disease
Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks

Full Information

First Posted
July 28, 2023
Last Updated
October 17, 2023
Sponsor
argenx
search

1. Study Identification

Unique Protocol Identification Number
NCT05979441
Brief Title
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
argenx

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EFG PH20 SC
Arm Type
Experimental
Arm Description
participants receiving efgartigimod PH20 SC on top of background treatment
Intervention Type
Biological
Intervention Name(s)
EFG PH20 SC
Intervention Description
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
Primary Outcome Measure Information:
Title
Incidence treatment-emergent adverse events and adverse event of special interest
Time Frame
Up to 60 weeks
Secondary Outcome Measure Information:
Title
Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS)
Time Frame
Up to 52 weeks
Title
Prednisone dose reduction (average monthly dose)
Time Frame
Up to 52 weeks
Title
Proportion of participants who discontinue corticosteroids
Time Frame
Up to 52 weeks
Title
Total improvement score (TIS)
Description
measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Time Frame
Up to 52 weeks
Title
Proportion of TIS responders (minimal, moderate, major)
Time Frame
up to 52 weeks
Title
Individual core set measures (CSMs) of the TIS
Description
measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Time Frame
up to 52 weeks
Title
Percentage of participants with clinically inactive disease
Time Frame
up to 52 weeks
Title
Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks
Time Frame
up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Information:
Facility Name
Investigator site US0010127
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site US0010161
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site BG3590019
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site CZ4200011
City
Praha 2
ZIP/Postal Code
12850
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site DK0450007
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site ES0340047
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site ES0340054
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site ES0340048
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site ES0340049
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site ES0340060
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site ES0340042
City
Sevilla
ZIP/Postal Code
9-41014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site ES0340039
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site ES0340046
City
Vigo
ZIP/Postal Code
36200
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs