BridgeMD
A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with active idiopathic inflammatory myopathy.
EU CTIS ID: 2022-502851-79-00
What this study is testing
To assess the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has completed ARGX-113-2007
- Is capable of providing signed informed consent and complying with protocol requirements
- Agrees to use contraceptive measures consistent with local regulations and the following: • women of childbearing potential (WOCBP) must have a negative urine pregnancy test at baseline before receiving investigational medicinal product (IMP).
You likely can't join if
- Intention to have major surgery during the ARGX-113-2011 study period; or any other medical condition that has arisen since enrollment in 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 to investigational medicinal product (IMP) 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 investigational medicinal product (IMP) in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit.
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- Taiwan
- Turkey
- Canada
- Peru
- Serbia
- United States
- Thailand
- Switzerland
- Argentina
- Korea, Republic of
- Japan
- Israel
- Australia
- United Kingdom
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; Taiwan; Turkey; Canada; Peru; Serbia and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.