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A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2, Randomized, Placebo-controlled, Parallel-group, Double-blinded, proof-of Concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren's Syndrome

NCT05817669•argenx

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.

Detailed Description

Primary Sjogren Syndrome (pSS) is an autoimmune disease with still unmet treatment needs. Efgartigimod, a human FcRn antagonist, has the potential to successfully treat pSS and improve disease manifestations by the reduction of IgG autoantibodies and immune complexes in pSS. The study design is randomized, double-blinded, and placebo-controlled to evaluate the effect of efgartigimod administered as an IV infusion compared to placebo. The study consists of a treatment period when all participants will receive infusions of IP/placebo for 24 weeks. At the end of the randomized treatment period, eligible participants may roll over to an OLE study or remain in this study through the end of the 56-day follow-up period.

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 informed consent form
•Is capable of providing signed informed consent and complying with protocol requirements
•Agrees to use contraceptive measures consistent with local regulations and measures described in the protocol
•Meets the following criteria at screening: ACR/EULAR 2016 pSS who met criteria ≤7 years before screening; ESSDAI ≥5; Anti-Ro/SS-A positive; Residual salivary flow (UWSF rate \>0 and/or SWSF rate \>0.10)

Exclusion Criteria

•Known autoimmune disease or any medical condition that, in the investigator's judgment,would interfere with an accurate assessment of clinical symptoms of pSS or puts the participant at undue risk
•History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP.
•Adequately treated participants with the following cancers may be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b) Clinically significant uncontrolled active acute or chronic bacterial, viral, or fungal infection
•Positive serum test at screening for an active infection with any of the following: HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available; HIV based on test results of a CD4 count of \<200 cells/mm3 that are associated with an AIDS-defining condition, HIV based on test results of a CD4 count of \>200 cells/mm3 not adequately treated with antiviral therapy
•Clinically significant disease, recent major surgery (within 3 months of screening), 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
•Immunoglobulin G (IgG) levels cannot be below a certain threshold ( 4g/L)
•Positive covid test at study start
•Some of the medications such as vaccines with live components or medicines that may be prescribed cannot be taken either shortly before or during this study
•Current participation in another interventional clinical study or previously participation in an efgartigimod clinical study and treatment with ≥1 dose of IMP
•Known hypersensitivity to IMP or 1 of its excipients
+4 more criteria

Locations (17)

Universitair Ziekenhuis Gent

Ghent, Belgium

Debreceni Egyetem

Debrecen, Hungary

Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

Székesfehérvár, Hungary

Universitair Medisch Centrum Groningen , Dept of Rheumatology and Clinical Immunology

Groningen, Netherlands

Ambulatorium Barbara Bazela

Elblag, Poland

MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.

Grodzisk Mazowiecki, Poland

Centrum Medyczne Plejady

Krakow, Poland

FutureMeds Krakow

Krakow, Poland

ETG Lublin

Lublin, Poland

Reumed Spolka z o.o.

Lublin, Poland

Key Dates

Start Date

April 4, 2023

Primary Completion Date

January 29, 2024

Completion Date

February 12, 2024

Last Updated

July 18, 2025

Enrollment

ACTUAL participants

Conditions

Primary Sjögren's Syndrome

Interventions

Efgartigimod

BIOLOGICAL

Placebo

BIOLOGICAL

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

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Primary Sjögren's Syndrome

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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: July 18, 2025Data 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

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

Inclusion Criteria

Exclusion Criteria

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

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

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