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

COMPLETEDPHASE2

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

NCT06203457•argenx

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (11)

Universitair Ziekenhuis Gent

Ghent, Belgium

Debreceni Egyetem

Debrecen, Hungary

Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

Székesfehérvár, Hungary

MCBK SC

Grodzisk Mazowiecki, Poland

Centrum Medyczne Plejady

Krakow, Poland

Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.

Poznan, Poland

Centrum Medyczne Pratia Poznan

Skorzewo, Poland

MICS Centrum Medyczne Warszawa

Warsaw, Poland

Klinika Reuma Park Sp zoo Sp K

Warsaw, Poland

Narodowy Instytut Geriatrii

Warsaw, Poland

Key Dates

Start Date

November 29, 2023

Primary Completion Date

February 3, 2025

Completion Date

February 3, 2025

Last Updated

February 20, 2026

Enrollment

ACTUAL participants

Conditions

Primary Sjögren's Syndrome

Interventions

Efgartigimod

BIOLOGICAL

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A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

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NOT_YET_RECRUITINGPHASE2

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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: March 29, 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

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

Inclusion Criteria

Exclusion Criteria

Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome

A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

Clinical Study to Investigate the Efficacy of Orally Administered SA001 in Patients With Primary Sjögren's Syndrome

Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome

PD of VAY736 in Patients With Primary Sjögren's Syndrome