2023-503915-14-00CompletedPhase 2
Open-Label Extension (OLE) Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren’s Syndrome (pSS)
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Jan 2025
Brief summary (registry, in English)
To evaluate the long-term safety of efgartigimod in patients with pSS
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 29 May 2023
- Start date
- 15 Nov 2023
- Lead sponsor
- Argenx
- Diseases
- Sjögren's disease
- EU CT number
- 2023-503915-14-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 27
- 17 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent | Gent | Belgium | Completed |
| University of Debrecen | Debrecen | Hungary | Completed |
| Bekes Megyei Koezponti Korhaz | Gyula | Hungary | Completed |
| Vita Verum Medical Bt. | Székesfehérvár | Hungary | Completed |
| Centrum Medyczne Plejady Sp. z o.o. S.K. | Cracow | Poland | Completed |
| Krakowskie Centrum Medyczne Sp. z o.o. | Cracow | Poland | Completed |
| Pratia S.A. | Dopiewo | Poland | Completed |
| Ambulatorium Sp. z o.o. | Elblag | Poland | Completed |
| Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak | Grodzisk Mazowiecki | Poland | Completed |
| Reumed Sp. z o.o. | Lublin | Poland | Completed |
| Pro Life Medica Sp. z o.o. | Lublin | Poland | Completed |
| Clinical Research Center Sp z o o Medic R Sp k | Poznan | Poland | Completed |
| Klinika Reuma Park Sp. z o.o. S.K. | Warsaw | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. | Warsaw | Poland | Completed |
| Centrum Medyczne Amed Sp. z o.o. | Warsaw | Poland | Completed |
| Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher | Warsaw | Poland | Completed |
| Futuremeds Sp. z o.o. | Wroclaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.