Open-Label Extension (OLE) Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren’s Syndrome (pSS)
- Conditions
- Primary Sjögren's SyndromeMedDRA version: 21.0Level: LLTClassification code: 10042846Term: Syndrome Sjogren's Class: 10028395Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]
- Registration Number
- CTIS2023-503915-14-00
- Lead Sponsor
- Argenx
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 27
The Participant is at least the legal age of consent for clinical trials when signing the ICF, The Participant is capable of providing signed informed consent, and complying with protocol requirements, The Participant agrees to use contraceptive measures consistent with local regulations and the following: a. WOCBP must have a negative urine pregnancy test at baseline before receiving IMP, The Participant has completed the qualifying efgartigimod pSS studies and agrees to continue study drug treatment without interruption in the extension study
The Participant has clinically significant disease (including newly diagnosed malignancy or cardiovascular disease) or intention to have surgery during the study; or any other medical condition that, in the investigator’s opinion, would confound the results of the study or put the participant at undue risk, The Participant is pregnant or intention to become pregnant during the study, The Participant has any severe systemic pSS manifestation that may put the participant at undue risk based on the investigator’s opinion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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