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

NCT05817669 | Completed Phase 2 Results

• 2 other identifiers: ARGX-113-21062021-005911-30
• Study Type: interventional
• Target: 34
• Locations: 4 countries
• Sites: 17

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.

Conditions

Primary Sjögren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24

  A Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) responder is defined as improvements in at least 3 of the 5 items of CRESS (systemic disease activity, patient-reported symptoms, tear gland function, salivary gland function and serology. The score ranges from 0 to 9 (higher score = worse symptoms).

  Week 24

Secondary Outcomes (13)

• Number of Participants With TEAEs, AESI, and SAEs

  Up to 32 weeks

• Percentage of Participants With MCII in ESSDAI at Week 24

  Week 24

• Percentage of Participants With Low Disease Activity in ESSDAI at Week 24

  Week 24

• Percentage of Participants With MCII in clinESSDAI at Week 24

  Week 24

• Percentage of Participants With Low Disease Activity in clinESSDAI at Week 24

  Week 24

Study Arms (2)

Efgartigimod IV arm

EXPERIMENTAL

patients receiving infusions of Efgartigimod IV

Biological: Efgartigimod

Placebo arm

PLACEBO COMPARATOR

patients receiving infusions of placebo IV

Biological: Placebo

Interventions

Efgartigimod BIOLOGICAL

Patients receiving efgartigimod infusions

Efgartigimod IV arm

Placebo BIOLOGICAL

Patients receiving placebo infusions

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• argenx: lead
• Iqvia Pty Ltd: collaborator

Study Sites (17)

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Debreceni Egyetem

Debrecen, 4032, Hungary

Location

Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

Székesfehérvár, 8000, Hungary

Location

Universitair Medisch Centrum Groningen , Dept of Rheumatology and Clinical Immunology

Groningen, 9713 GZ, Netherlands

Location

Ambulatorium Barbara Bazela

Elblag, 82-300, Poland

Location

MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.

Grodzisk Mazowiecki, 05-825, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

FutureMeds Krakow

Krakow, 31-501, Poland

Location

ETG Lublin

Lublin, 20-412, Poland

Location

Reumed Spolka z o.o.

Lublin, 20-607, Poland

Location

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

Poznan, 60-848, Poland

Location

Centrum Medyczne Pratia Poznan

Skórzewo, 60-185, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, 00-874, Poland

Location

KO-Med - Centrum Badań Medycznych NIGRiR

Warsaw, 02-637, Poland

Location

Centrum Medyczne Reuma Park

Warsaw, 02-691, Poland

Location

FutureMeds Targowek

Warsaw, 03-291, Poland

Location

FutureMeds Wroclaw

Wroclaw, 50-088, Poland

Location

MeSH Terms

Interventions

efgartigimod alfa

Results Point of Contact

• Title: Regulatory manager
• Organization: Argenx

regulatory@argenx.com

Please email:

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will be randomized to receive efgartigimod 10 mg/kg or placebo in a 2:1 ratio, respectively. All participants will receive efgartigimod IV 10 mg/kg or placebo once weekly for 24 weeks during the treatment period
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: April 18, 2023
• Study Start: April 4, 2023
• Primary Completion: January 29, 2024
• Study Completion: February 12, 2024
• Last Updated: July 18, 2025
• Results First Posted: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); PL (13); BE (1); HU (2)