Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome (pSS) Who Complete Qualifying Efgartigimod pSS Studies

Efgartigimod has the potential to improve disease manifestations by the reduction of IgG autoantibodies in Sjogren's Syndrome (SjD or pSS). This open-label extension study will evaluate the long-term safety of efgartigimod in participants with SjD who have completed the treatment period of the qualifying efgartigimod study (ARGX-113-2106).

Inclusion Criteria:

• Is at least the legal age of consent for clinical trials when signing the ICF
• Is capable of providing signed informed consent and complying with protocol requirements
• Agrees to use contraceptive measures consistent with local regulations and the following: WOCBP must have a negative urine pregnancy test at baseline before receiving IMP
• Has completed the qualifying efgartigimod SjD studies and agrees to continue study drug treatment without interruption in the extension study

Exclusion Criteria:

• 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
• Pregnant or intention to become pregnant during the study
• Any severe systemic SjD manifestation that may put the participant at undue risk based on the investigator's opinion