臨床研究等提出・公開システム

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 (alkivia+)

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

Agna Neto, MD

Argenx BV

4-1-3 Kyuutaromachi, Chuo-ku, Osaka, 541-0056, Japan

Japan-Chiken@iconplc.com

Clinical trial contact

ICON Clinical Research GK

4-1-3 Kyutaro-cho, Chuuou-ku, Osaka-city, Osaka, 541-0056, Japan

+81-6-4560-2001

Japan-Chiken@iconplc.com

Recruiting

Dec. 05, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

- 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. However, the investigator determines that administering the investigational medicinal product to participant would be beneficial for the participant(criteria: if the participant is evaluated as "much better" or "moderately better" for at least 12 weeks on the CGI-C and PGI-C assessments

Both

Idiopathic inflammatory myopathy

Biological: efgartigimod PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20

- Incidence and severity of TEAEs, AESIs, and SAEs
- Changes and abnormalities in vital signs, ECG, and laboratory parameters

Nov. 21, 2024

No

United States/Argentina/Australia/Austria/Belgium/Bulgaria/Canada/Cyprus/Czechia/Denmark/France/Georgia/Germany/Greece/Hungary/Ireland/Israel/Italy/Korea Republic of/Lithuania/Mexico/Netherland/Peru/Poland/Portugal/Servia/Sulovakia/Spain/Sweden/Switzerland