Trial · NCT05817669
A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)
NCT05817669, Phase 2, Completed, argenx; results first posted 2025-07-18
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS). Trials, record NCT05817669. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05817669
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)
- NCT number
- NCT05817669
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- argenx
- Conditions
- Primary Sjögren's Syndrome
- Interventions
- Efgartigimod, Placebo
- First posted
- 2023-04-18
- Last updated
- 2025-07-18
- Other registries' IDs
- eudract:2021-005911-30
- Results first posted
- 2025-07-18
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24 | Week 24 | A Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) responder is defined as improvements in at least 3 of the 5 items of CRESS (systemic disease activity, patient-reported symptoms, tear gland function, salivary gland function and serology. The score ranges from 0 to 9 (higher score = worse symptoms). |
| Secondary | Number of Participants With TEAEs, AESI, and SAEs | Up to 32 weeks | A treatment-emergent adverse event (TEAE): adverse events reported from the first dose up to and including 60 days after the final dose were considered treatment-emergent. Serious adverse event (SAE): adverse event that 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 other situations. Adverse event of special interest (AESI): adverse event related to 'Infections and infestations'. |
| Secondary | Percentage of Participants With MCII in ESSDAI at Week 24 | Week 24 | European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score =worse symptoms). Minimally clinically important improvement (MCII) in ESSDAI was defined as improvement of at least 3 points in ESSDAI score at Week 24. |
| Secondary | Percentage of Participants With Low Disease Activity in ESSDAI at Week 24 | Week 24 | ESSDAI measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score =worse symptoms). Low disease activity in ESSDAI was defined as ESSDAI score of less than 5 at Week 24. |
| Secondary | Percentage of Participants With MCII in clinESSDAI at Week 24 | Week 24 | Clinical (clin)ESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). Minimal clinically important improvement (MCII) in clinESSDAI was defined as improvement of at least 3 points in clinESSDAI score at Week 24. |
| Secondary | Percentage of Participants With Low Disease Activity in clinESSDAI at Week 24 | Week 24 | clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). Low disease activity in clinESSDAI was defined as clinESSDAI score of less than 5 at Week 24. |
| Secondary | Percentage of Participants With MCII in ESSPRI at Week 24 | Week 24 | Minimal clinically important improvement in ESSPRI was defined as decrease of 1 point or at least ≥15% at Week 24. ESSPRI is a questionnaire that has been developed to measure self-reported symptoms in participants with pSjD. The score ranges from 0 (no symptoms) to 10 (more symptoms). |
| Secondary | Change From Baseline in ESSDAI Score at Week 24 | Baseline (Day 1) and Week 24 | ESSDAI measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score = worse symptoms). |
| Secondary | Change From Baseline in clinESSDAI Score at Week 24 | Baseline (Day 1) and Week 24 | clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). |
| Secondary | Change From Baseline in ESSPRI Score at Week 24 | Baseline (Day 1) and Week 24 | ESSPRI is a questionnaire that has been developed to measure self-reported symptoms in participants with pSjD. The score ranges from 0 (no symptoms) to 10 (more symptoms). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24 | Week 24 | The Efficacy Analysis Set (EAS) included all participants eligible for efficacy evaluation. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With TEAEs, AESI, and SAEs | Up to 32 weeks | The Safety Analysis Set (SAF) included all participants exposed to the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With MCII in ESSDAI at Week 24 | Week 24 | EAS. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Low Disease Activity in ESSDAI at Week 24 | Week 24 | EAS. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With MCII in clinESSDAI at Week 24 | Week 24 | EAS. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Low Disease Activity in clinESSDAI at Week 24 | Week 24 | EAS. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With MCII in ESSPRI at Week 24 | Week 24 | EAS. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in ESSDAI Score at Week 24 | Baseline (Day 1) and Week 24 | EAS - Only participants with data collected at baseline and Week 24 are reported. | score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in clinESSDAI Score at Week 24 | Baseline (Day 1) and Week 24 | EAS - Only participants with data collected at baseline and Week 24 are reported. | score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in ESSPRI Score at Week 24 | Baseline (Day 1) and Week 24 | EAS - Only participants with data collected at Baseline and Week 24 are reported. | score on a scale | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24 | Efgartigimod | 45.5 | 95% Confidence Interval 26.92 to 65.34 | Percentage of participants | |
| Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24 | Placebo | 11.1 | 95% Confidence Interval 1.99 to 43.50 | Percentage of participants | |
| Number of Participants With TEAEs, AESI, and SAEs | Efgartigimod | Any TEAE | 20 | Participants | |
| Number of Participants With TEAEs, AESI, and SAEs | Placebo | Any TEAE | 7 | Participants | |
| Number of Participants With TEAEs, AESI, and SAEs | Efgartigimod | Any AESI | 15 | Participants | |
| Number of Participants With TEAEs, AESI, and SAEs | Placebo | Any AESI | 5 | Participants | |
| Number of Participants With TEAEs, AESI, and SAEs | Efgartigimod | Any SAE | 1 | Participants | |
| Number of Participants With TEAEs, AESI, and SAEs | Placebo | Any SAE | 0 | Participants | |
| Percentage of Participants With MCII in ESSDAI at Week 24 | Efgartigimod | 72.7 | 95% Confidence Interval 51.85 to 86.85 | Percentage of participants | |
| Percentage of Participants With MCII in ESSDAI at Week 24 | Placebo | 55.6 | 95% Confidence Interval 26.67 to 81.12 | Percentage of participants |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Efgartigimod | 23 | |
| Overall Study | STARTED | Placebo | 11 | |
| Overall Study | COMPLETED | Efgartigimod | 20 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Efgartigimod | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Efgartigimod | 0 | 23 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo | 1 | 11 | 1 |
| other | Palpitations | Cardiac disorders | Efgartigimod | 0 | 23 | 0 |
| other | Palpitations | Cardiac disorders | Placebo | 1 | 11 | 1 |
| other | Motion sickness | Ear and labyrinth disorders | Efgartigimod | 0 | 23 | 0 |
| other | Motion sickness | Ear and labyrinth disorders | Placebo | 1 | 11 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Efgartigimod | 0 | 23 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 11 | 1 |
| other | Abdominal pain lower | Gastrointestinal disorders | Efgartigimod | 0 | 23 | 0 |
| other | Abdominal pain lower | Gastrointestinal disorders | Placebo | 1 | 11 | 1 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Efgartigimod | 0 | 23 |
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, other adverse events | Efgartigimod | 20 | 23 |
| Total, other adverse events | Placebo | 7 | 11 |
| Total, serious adverse events | Efgartigimod | 1 | 23 |
| Total, serious adverse events | Placebo | 0 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41997805 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Efgartigimod vs Placebo: deaths from any cause | Trial comparisons |
| Efgartigimod vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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