Open-Label Extension (OLE) Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren’s Syndrome (pSS)
Key facts
- Where
- Debrecen, Gyula és Székesfehérvár, MagyarországSee the 3 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Magyarország
- University of DebrecenDebrecen, MagyarországNo longer taking part
- Bekes Megyei Koezponti KorhazGyula, MagyarországNo longer taking part
- Vita Verum Medical Bt.Székesfehérvár, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Argenx
- Trial code
- EU 2023-503915-14-00
- Record updated
- 2025. január 13.
- Original description
To evaluate the long-term safety of efgartigimod in patients with pSSRead full original descriptionShow less
ARGX-113-2211: Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients with primary Sjögren’s Syndrome (pSS) who complete qualifying efgartigimod pSS studies
To evaluate the long-term safety of efgartigimod in patients with pSS
Inclusion: The Participant is at least the legal age of consent for clinical trials when signing the ICF; The Participant is capable of providing signed informed consent, and complying with protocol requirements; The Participant agrees to use contraceptive measures consistent with local regulations and the following: a. WOCBP must have a negative urine pregnancy test at baseline before receiving IMP; The Participant has completed the qualifying efgartigimod pSS studies and agrees to continue study drug treatment without interruption in the extension study.
Exclusion: The Participant has 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; The Participant is pregnant or intention to become pregnant during the study; The Participant has any severe systemic pSS manifestation that may put the participant at undue risk based on the investigator’s opinion.