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

ARGX-113-2211

Efgartigimod contributes to successfully treat pSS and has the potential to improve disease manifestations by the reduction of IgG autoantibodies in pSS. This open-label extension study will evaluate the long-term safety of efgartigimod in participants with pSS who have completed the treatment period of the qualifying efgartigimod studies (including ARGX-113-2106).

2023-11-28

2025-02-14

2025-08-29

Recruiting

Early phase I

30

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 pSS 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 pSS manifestation that may put the participant at undue risk based on the investigator's opinion

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-01-12