Trial · NCT06203457
Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome
NCT06203457, Phase 2, Completed, argenx; results first posted 2026-02-20
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome. Trials, record NCT06203457. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06203457
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome
- NCT number
- NCT06203457
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- argenx
- Conditions
- Primary Sjögren's Syndrome
- Interventions
- Efgartigimod
- First posted
- 2024-01-12
- Last updated
- 2026-02-20
- Results first posted
- 2026-02-20
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With TEAEs, TESAEs and TEAESIs | From the first dose of study drug (Day 1) up to 60 days post last study drug, approximately 56 weeks | An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: 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 any other medically important event. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration. Adverse events in the 'Infections and infestations' SOC were defined as AE of Special Interest (AESIs) because efgartigimod causes a transient reduction in total IgG levels. |
| Secondary | Number of CRESS Responders at Weeks 24 and 48 | Weeks 24 and 48 | A composite of relevant endpoints for Sjögren's syndrome (CRESS) measures systemic disease activity, patient-reported symptoms, tear gland function, salivary gland function, and serology, developed to assess treatment efficacy in participants with SjD. A responder is defined as improvement in at least 3 of the above mentioned 5 items of CRESS. The score ranges from 0 to 9 (higher score = worse symptoms). Responder rates for the efgartigimod-efgartigimod group in the follow-up study are supplemental to those in the antecedent study (ARGX-113-2106). Because responders from the ARGX-113-2106 study (mainly in the efgartigimod-efgartigimod group) potentially started the ARGX-113-2211 with lower baseline scores, further improvement on this efficacy measure is inherently challenging due to clinical and biological limitations. |
| Secondary | Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSDAI at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | European alliance of associations for rheumatology (EULAR) SjD activity index (ESSDAI) measures systemic disease activity in 12 domains. The activity levels of each domain are multiplied by their respective weights to obtain the total score between 0 and 123 (higher score = worse symptoms). Minimally clinically important improvement in ESSDAI was defined as improvement of at least 3 points in ESSDAI score at Weeks 24 and 48. Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106. Responder rates for the efg-efg group in the follow-up study are supplemental to those in the ARGX-113-2106 study. Because responders from the ARGX-113-2106 study (mainly in the efg-efg group) potentially started the ARGX-113-2211 with lower baseline scores, further improvement on this efficacy measure is inherently challenging due to clinical and biological limitations. |
| Secondary | Number of Participants With Low Disease Activity in ESSDAI at Weeks 24 and 48 | Weeks 24 and 48 | ESSDAI measures systemic disease activity in participants with SjD and consists of 12 domains. The activity levels of each domain (range: 0-3 points) are multiplied by their respective weights (range: 1-6 points) to obtain the total score between 0 and 123 (higher score = worse symptoms). Low disease activity in ESSDAI was defined as ESSDAI score of less than 5 at Weeks 24 and 48. Responder rates for the efgartigimod-efgartigimod group in the follow-up study are supplemental to those in the antecedent study (ARGX-113-2106). Because responders from the ARGX-113-2106 study (mainly in the efgartigimod-efgartigimod group) potentially started the ARGX-113-2211 with lower baseline scores, further improvement on this efficacy measure is inherently challenging due to clinical and biological limitations. |
| Secondary | Number of Participants With Minimal Clinically Important Improvement From Baseline in clinESSDAI at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | Clinical EULAR Sjögren's syndrome disease activity index (clinESSDAI) includes same 11 organ-specific domains as ESSDAI but with different domain weighting and this scale does not have biological domain.This way any change in clinESSDAI score reflects disease specific features irrespective of B-cell activity. clinESSDAI score ranges between 0-135 (higher score=worse symptoms).Minimal clinically important improvement in clinESSDAI was defined as improvement of at least 3 points in clinESSDAI score at Weeks 24 and 48.Baseline=last available non-missing measurement from parent study ARGX-113-2106.Responder rates for efgartigimod-efgartigimod group in follow-up study are supplemental to those in antecedent study (ARGX-113-2106).Because responders from ARGX-113-2106 study (mainly in efgartigimod-efgartigimod group) potentially started ARGX-113-2211 with lower baseline scores,further improvement on this efficacy measure is inherently challenging due to clinical and biological limitations. |
| Secondary | Number of Participants With Low Disease Activity in clinESSDAI at Weeks 24 and 48 | Weeks 24 and 48 | clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and this scale does not have the biological domain. This way any change in clinESSDAI score reflects 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 Weeks 24 and 48. Responder rates for the efgartigimod-efgartigimod group in the follow-up study are supplemental to those in the antecedent study (ARGX-113-2106). Because responders from the ARGX-113-2106 study (mainly in the efgartigimod-efgartigimod group) potentially started the ARGX-113-2211 with lower baseline scores, further improvement on this efficacy measure is inherently challenging due to clinical and biological limitations. |
| Secondary | Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSPRI at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | EULAR Sjögren's syndrome patient-reported index (ESSPRI) is a questionnaire developed to measure self-reported symptoms in participants with SjD and consists of 3 items that measure dryness, fatigue, and pain. The total global score ranges from 0 to 10 by averaging the numeric scores for pain, fatigue, and dryness, with higher scores indicating more symptoms. Minimal clinically important improvement in ESSPRI was defined as decrease of 1 point or at least \>=15% at Weeks 24 and 48. Baseline was defined as the last available non-missing measurement from the study ARGX-113-2106. Responder rates for the efg-efg group in the follow-up study are supplemental to those in the ARGX-113-2106 study. Because responders from the ARGX-113-2106 study (mainly in the efg-efg group) potentially started the ARGX-113-2211 with lower baseline scores, further improvement on this measure is inherently challenging due to biological and clinical limitations. |
| Secondary | Change From Baseline in ESSDAI Score at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | ESSDAI measures systemic disease activity in participants with SjD and consists of 12 domains: 11 organ-specific domains (cutaneous, pulmonary, renal, articular, muscular, peripheral nervous system, central nervous system, hematological, glandular, constitutional, and lymphadenopathic) and 1 biological domain reflecting B-cell activity that contributes to disease activity level scoring. The activity levels of each domain (range: 0-3 points) are multiplied by their respective weights (range: 1-6 points) to obtain the total score between 0 and 123 (higher score = worse symptoms). Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106. |
| Secondary | Change From Baseline in clinESSDAI Score at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and this scale does not have the biological domain. This way any change in clinESSDAI score reflects disease specific features irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106. |
| Secondary | Change From Baseline in ESSPRI Score at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | ESSPRI is a questionnaire developed to measure self-reported symptoms in participants with SjD and consists of 3 items that measure dryness, fatigue, and pain. Each item includes a numeric rating scale ranging from 0: no symptoms (dryness, fatigue, or pain) to 10: maximal imaginable (dryness, fatigue, or pain). The total global score ranges from 0 to 10 and the ESSPRI is calculated by averaging the numeric scores for pain, fatigue, and dryness, with higher scores indicating more symptoms. Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With TEAEs, TESAEs and TEAESIs | From the first dose of study drug (Day 1) up to 60 days post last study drug, approximately 56 weeks | The safety analysis set (SAF) included all FAS participants who had been administered at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of CRESS Responders at Weeks 24 and 48 | Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSDAI at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Low Disease Activity in ESSDAI at Weeks 24 and 48 | Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Minimal Clinically Important Improvement From Baseline in clinESSDAI at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Low Disease Activity in clinESSDAI at Weeks 24 and 48 | Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSPRI at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in ESSDAI Score at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in clinESSDAI Score at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in ESSPRI Score at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | score on a scale | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group61
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With TEAEs, TESAEs and TEAESIs | Efgartigimod-Efgartigimod | TEAEs | 15 | Participants | |
| Number of Participants With TEAEs, TESAEs and TEAESIs | Placebo-Efgartigimod | TEAEs | 6 | Participants | |
| Number of Participants With TEAEs, TESAEs and TEAESIs | Efgartigimod-Efgartigimod | TESAEs | 0 | Participants | |
| Number of Participants With TEAEs, TESAEs and TEAESIs | Placebo-Efgartigimod | TESAEs | 2 | Participants | |
| Number of Participants With TEAEs, TESAEs and TEAESIs | Efgartigimod-Efgartigimod | TEAESIs | 10 | Participants | |
| Number of Participants With TEAEs, TESAEs and TEAESIs | Placebo-Efgartigimod | TEAESIs | 5 | Participants | |
| Number of CRESS Responders at Weeks 24 and 48 | Efgartigimod-Efgartigimod | Week 24 | 1 | 0.30 to 25.01 | Participants |
| Number of CRESS Responders at Weeks 24 and 48 | Placebo-Efgartigimod | Week 24 | 4 | 22.53 to 87.12 | Participants |
| Number of CRESS Responders at Weeks 24 and 48 | Efgartigimod-Efgartigimod | Week 48 | 2 | 2.13 to 32.62 | Participants |
| Number of CRESS Responders at Weeks 24 and 48 | Placebo-Efgartigimod | Week 48 | 2 | 5.34 to 65.87 | Participants |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 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-Efgartigimod | 17 | |
| Overall Study | STARTED | Placebo-Efgartigimod | 7 | |
| Overall Study | COMPLETED | Efgartigimod-Efgartigimod | 12 | |
| Overall Study | COMPLETED | Placebo-Efgartigimod | 3 | |
| Overall Study | NOT COMPLETED | Efgartigimod-Efgartigimod | 5 | |
| Overall Study | NOT COMPLETED | Placebo-Efgartigimod | 4 |
Source ClinicalTrials.gov
Adverse events154
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-Efgartigimod | 1 | 17 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo-Efgartigimod | 0 | 7 | 0 |
| other | Eye irritation | Eye disorders | Efgartigimod-Efgartigimod | 1 | 17 | 1 |
| other | Eye irritation | Eye disorders | Placebo-Efgartigimod | 0 | 7 | 0 |
| other | Glaucoma | Eye disorders | Efgartigimod-Efgartigimod | 1 | 17 | 1 |
| other | Glaucoma | Eye disorders | Placebo-Efgartigimod | 0 | 7 | 0 |
| other | Vision blurred | Eye disorders | Efgartigimod-Efgartigimod | 1 | 17 | 1 |
| other | Vision blurred | Eye disorders | Placebo-Efgartigimod | 0 | 7 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Efgartigimod-Efgartigimod | 1 | 17 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo-Efgartigimod | 0 | 7 | 0 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Efgartigimod-Efgartigimod | 0 | 17 |
| Total, all-cause mortality | Placebo-Efgartigimod | 0 | 7 |
| Total, other adverse events | Efgartigimod-Efgartigimod | 15 | 17 |
| Total, other adverse events | Placebo-Efgartigimod | 6 | 7 |
| Total, serious adverse events | Efgartigimod-Efgartigimod | 0 | 17 |
| Total, serious adverse events | Placebo-Efgartigimod | 2 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Efgartigimod-Efgartigimod vs Placebo-Efgartigimod: Number of Participants With ADA Against Efgartigimod Over the 48-week Treatment Period | Trial comparisons |
| Efgartigimod-Efgartigimod vs Placebo-Efgartigimod: deaths from any cause | Trial comparisons |
| Efgartigimod-Efgartigimod vs Placebo-Efgartigimod: 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.
GET https://conductscience.org/api/trials/v1/NCT06203457
GET https://conductscience.org/api/trials/v1/NCT06203457/results?page=2