Phase 2
N=24
Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome
Primary Sjögren's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT06203457 ↗Enrolled (actual)
24
Serious AEs
8.3%
Results posted
Feb 2026
Primary outcome: Primary: Number of Participants With TEAEs, TESAEs and TEAESIs — 15; 6; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Efgartigimod (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- argenx
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With TEAEs, TESAEs and TEAESIs |
15; 6; 0; 2; 10; 5 | — |
| SECONDARY Number of CRESS Responders at Weeks 24 and 48 |
1; 4; 2; 2 | — |
| SECONDARY Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSDAI at Weeks 24 and 48 |
3; 2; 1; 2 | — |
| SECONDARY Number of Participants With Low Disease Activity in ESSDAI at Weeks 24 and 48 |
9; 4; 7; 3 | — |
| SECONDARY Number of Participants With Minimal Clinically Important Improvement From Baseline in clinESSDAI at Weeks 24 and 48 |
2; 2; 1; 2 | — |
| SECONDARY Number of Participants With Low Disease Activity in clinESSDAI at Weeks 24 and 48 |
9; 4; 7; 3 | — |
| SECONDARY Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSPRI at Weeks 24 and 48 |
4; 1; 4; 2 | — |
| SECONDARY Change From Baseline in ESSDAI Score at Weeks 24 and 48 |
0.000; -3.000; -1.500; -4.000 | — |
| SECONDARY Change From Baseline in clinESSDAI Score at Weeks 24 and 48 |
0.000; -3.000; -0.500; -4.000 | — |
| SECONDARY Change From Baseline in ESSPRI Score at Weeks 24 and 48 |
0.000; 0.167; 0.333; -2.000 | — |
| SECONDARY Number of STAR Responders at Weeks 24 and 48 |
1; 2; 2; 3 | — |
| SECONDARY Percent Change From Baseline in Total IgG Levels in Serum at Week 48 |
36.266; -37.800 | — |
| SECONDARY Percent Change From Baseline in Autoantibodies in Serum at Week 48 |
-1.227; -14.646; 82.487; 0.000 | — |
| SECONDARY Serum Concentrations of Efgartigimod |
14.74; 213.3; 215.9; 4.428; 1.558; 5.725 | — |
| SECONDARY Number of Participants With ADA Against Efgartigimod Over the 48-week Treatment Period |
6; 4 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06203457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.