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COMPLETEDPhase 2NCT06203457

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

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 ...

Lead sponsor: argenx•11 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

argenx

Collaborators

Iqvia Pty Ltd

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 20, 2026Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment24

Start dateNov 2023

Last updatedFeb 20, 2026

Condition

Primary Sjögren's Syndrome

Locations shown

Universitair Ziekenhuis Gent

Ghent

Debreceni Egyetem

Debrecen

Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

Székesfehérvár

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions