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

NCT ID: NCT05817669

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2024-02-12

Brief 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.

Conditions

Primary Sjögren's Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Efgartigimod IV arm

patients receiving infusions of Efgartigimod IV

Group Type: EXPERIMENTAL

Efgartigimod

Intervention Type: BIOLOGICAL

Patients receiving efgartigimod infusions

Placebo arm

patients receiving infusions of placebo IV

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Patients receiving placebo infusions

Interventions

Efgartigimod

Patients receiving efgartigimod infusions

Intervention Type: BIOLOGICAL

Placebo

Patients receiving placebo infusions

Intervention Type: BIOLOGICAL

Eligibility Criteria

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
• History (within 12 months of screening) of current alcohol, drug, or medication abuse as assessed by the investigator
• Pregnant or lactating state or intention to become pregnant during the study
• Secondary Sjögren's syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition is the primary diagnosis
• Chinese traditional medicine with known immunomodulatory action

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iqvia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

argenx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

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

Poznan, , Poland

Centrum Medyczne Pratia Poznan

Skórzewo, , Poland

MICS Centrum Medyczne Warszawa

Warsaw, , Poland

KO-Med - Centrum Badań Medycznych NIGRiR

Warsaw, , Poland

Centrum Medyczne Reuma Park

Warsaw, , Poland

FutureMeds Targowek

Warsaw, , Poland

FutureMeds Wroclaw

Wroclaw, , Poland

Countries

Belgium; Hungary; Netherlands; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-005911-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ARGX-113-2106

Identifier Type: -

Identifier Source: org_study_id