Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy

Overview

About this study

The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in
ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.

IIM is a disease of the immune system that causes weakness of the pelvic muscles, the shoulder girdle muscles, or both. These symptoms lead to difficulties in ADL and reduce quality of life.  The typical treatment for IIM is high-dose glucocorticoids combined with immunosuppressive drugs.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/17/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Jaimin Shah, M.D.

Open for enrollment

Contact information:

Megan Donahue

Donahue.Megan@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20562185

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