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

argenx

Status and phase

Completed

Phase 2

Conditions

Primary Sjögren's Syndrome

Treatments

Biological: Efgartigimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT06203457

ARGX-113-2211

Details and patient eligibility

About

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).

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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