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

NCT06203457 | Completed Phase 2 Results

• 1 other identifier: ARGX-113-2211
• Study Type: interventional
• Target: 24
• Locations: 3 countries
• Sites: 11

Brief 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).

Conditions

Primary Sjögren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of Participants With TEAEs, TESAEs and TEAESIs

  An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration. Adverse events in the 'Infections and infestations' SOC were defined as AE of Special Interest (AESIs) because efgartigimod causes a transient reduction in total IgG levels.

  From the first dose of study drug (Day 1) up to 60 days post last study drug, approximately 56 weeks

Secondary Outcomes (14)

• Number of CRESS Responders at Weeks 24 and 48

  Weeks 24 and 48

• Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSDAI at Weeks 24 and 48

  Baseline (Day 1) and Weeks 24 and 48

• Number of Participants With Low Disease Activity in ESSDAI at Weeks 24 and 48

  Weeks 24 and 48

• Number of Participants With Minimal Clinically Important Improvement From Baseline in clinESSDAI at Weeks 24 and 48

  Baseline (Day 1) and Weeks 24 and 48

• Number of Participants With Low Disease Activity in clinESSDAI at Weeks 24 and 48

  Weeks 24 and 48

Study Arms (1)

Efgartigimod

EXPERIMENTAL

All participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study.

Biological: Efgartigimod

Interventions

Efgartigimod BIOLOGICAL

Patients receiving efgartigimod infusions

Efgartigimod

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• argenx: lead
• Iqvia Pty Ltd: collaborator

Study Sites (11)

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Debreceni Egyetem

Debrecen, 4032, Hungary

Location

Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

Székesfehérvár, 8000, Hungary

Location

MCBK SC

Grodzisk Mazowiecki, 05 825, Poland

Location

Centrum Medyczne Plejady

Krakow, 30 363, Poland

Location

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

Poznan, 60-848, Poland

Location

Centrum Medyczne Pratia Poznan

Skorzewo, 60 185, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, 00 874, Poland

Location

Klinika Reuma Park Sp zoo Sp K

Warsaw, 02 665, Poland

Location

Narodowy Instytut Geriatrii

Warsaw, 02637, Poland

Location

FutureMeds sp zoo

Wroclaw, 50 088, Poland

Location

MeSH Terms

Interventions

efgartigimod alfa

Results Point of Contact

• Title: Regulatory Manager
• Organization: argenx BV

regulatory@argenx.com

+32 93103400

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: January 12, 2024
• Study Start: November 29, 2023
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (2); PL (8); BE (1)