Status:
COMPLETED
Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome
Lead Sponsor:
argenx
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Primary Sjögren's Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Efgartigimod contributes to successfully treat pSS and has the potential to improve disease manifestations by the reduction of IgG autoantibodies in pSS. This open-label extension study will evaluate ...
Detailed Description
ARGX-113-2211 is a long-term, single-arm, open-label, multicenter extension study of the pSS-qualifying efgartigimod studies designed to evaluate the long-term safety of efgartigimod in adult patients...
Eligibility Criteria
Inclusion
- 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 pSS studies and agrees to continue study drug treatment without interruption in the extension study
Exclusion
- 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 pSS manifestation that may put the participant at undue risk based on the investigator's opinion
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06203457
Start Date
August 15 2023
End Date
February 3 2025
Last Update
April 3 2025
Active Locations (11)
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1
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
2
Debreceni Egyetem
Debrecen, Hungary, 4032
3
Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
Székesfehérvár, Hungary, 8000
4
MCBK SC
Grodzisk Mazowiecki, Poland, 05 825