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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efgartigimod | Experimental | All participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod | Biological | Patients receiving efgartigimod infusions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With TEAEs, TESAEs and TEAESIs | 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. | From the first dose of study drug (Day 1) up to 60 days post last study drug, approximately 56 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of CRESS Responders at 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium | |||
| Debreceni Egyetem |
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The study consisted of a treatment period (48 weeks) in which all participants received efgartigimod. A total of 24 participants were treated in this study.
This open-label, multicenter extension study was conducted at 11 sites in Belgium, Hungary, and Poland in adult participants with Sjögren's disease (SjD) who completed parent efgartigimod study ARGX-113-2106 (NCT05817669).
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| ID | Title | Description |
|---|---|---|
| FG000 | Efgartigimod-Efgartigimod | Participants received efgartigimod 10 milligram/kilogram (mg/kg) via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study. This reporting group presents the participants who also received efgartigimod in the parent study (ARGX-113-2106). |
| FG001 | Placebo-Efgartigimod | Participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study. This reporting group presents the participants who received placebo in the parent study (ARGX-113-2106). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was performed on full analysis set (FAS) which included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Efgartigimod-Efgartigimod | Participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study. This reporting group presents the participants who also received efgartigimod in the parent study (ARGX-113-2106). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With TEAEs, TESAEs and TEAESIs | 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. | The safety analysis set (SAF) included all FAS participants who had been administered at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | From the first dose of study drug (Day 1) up to 60 days post last study drug, approximately 56 weeks |
From the first dose of study drug (Day 1) up to 60 days post last study drug, approximately 56 weeks
The SAF included all FAS participants who had been administered at least 1 dose of study drug. Laboratory abnormalities were reported as AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Efgartigimod-Efgartigimod | Participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study. This reporting group presents the participants who also received efgartigimod in the parent study (ARGX-113-2106). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Manager | argenx BV | +32 93103400 | regulatory@argenx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 24, 2023 | Feb 3, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2025 | Feb 3, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000718373 | efgartigimod alfa |
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| Weeks 24 and 48 |
| Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSDAI at 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. | Baseline (Day 1) and Weeks 24 and 48 |
| Number of Participants With Low Disease Activity in ESSDAI at 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. | Weeks 24 and 48 |
| Number of Participants With Minimal Clinically Important Improvement From Baseline in clinESSDAI at 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. | Baseline (Day 1) and Weeks 24 and 48 |
| Number of Participants With Low Disease Activity in clinESSDAI at 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. | Weeks 24 and 48 |
| Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSPRI at 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. | Baseline (Day 1) and Weeks 24 and 48 |
| Change From Baseline in ESSDAI Score at 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. | Baseline (Day 1) and Weeks 24 and 48 |
| Change From Baseline in clinESSDAI Score at 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. | Baseline (Day 1) and Weeks 24 and 48 |
| Change From Baseline in ESSPRI Score at 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. | Baseline (Day 1) and Weeks 24 and 48 |
| Number of STAR Responders at Weeks 24 and 48 | Sjögren's tool for assessing response (STAR) is a composite endpoint assessing multiple clinically relevant disease features. A STAR responder is defined as a participant with a score of at least 5 points. Due to the weighting, participant must be a responder on either systemic disease activity (ESSDAI), patient-reported symptoms (ESSPRI), or both to be an overall STAR responder. The score ranges between 0 and 9 (higher score = worse outcome). 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. | Weeks 24 and 48 |
| Percent Change From Baseline in Total IgG Levels in Serum at Week 48 | Blood samples were collected at indicated timepoints to assess the total Immunoglobulin (Ig)G levels in serum. Total IgG concentrations were quantified using validated methods at a diagnostical laboratory. Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106. | Baseline (Day 1) and Week 48 |
| Percent Change From Baseline in Autoantibodies in Serum at Week 48 | Blood samples were collected at indicated timepoints to assess serum autoantibodies: anti-Ro/Sjögren's syndrome-related antigen A (SS-A) and anti-La/Sjögren's syndrome-related antigen B (SS-B). Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106. | Baseline (Day 1) and Week 48 |
| Serum Concentrations of Efgartigimod | Serum samples were collected at indicated timepoints to assess the pharmacokinetic (PK) profile of efgartigimod. | Pre-dose and post-dose at Baseline (Day 1) and pre-dose at Weeks 24 and 48 |
| Number of Participants With ADA Against Efgartigimod Over the 48-week Treatment Period | Blood samples were collected to assess anti-drug antibodies (ADAs) against efgartigimod. Samples were analyzed by the designated laboratory in a 3-tiered approach using validated immunogenicity assays. ADA incidence included total number of participants with treatment-boosted and treatment-induced ADA. Treatment-boosted ADA was defined as participants who had a baseline positive sample and the titer value increased 4-fold or more compared to baseline. Treatment-induced ADA was defined as participants who had a baseline negative sample and at least 1 positive post-baseline samples. Number of participants with ADA incidence is presented here. | From Baseline (Day 1) up to 48 weeks |
| Debrecen |
| 4032 |
| Hungary |
| Vita Verum Medical Egeszsegugyi Szolgaltato Bt. | Székesfehérvár | 8000 | Hungary |
| MCBK SC | Grodzisk Mazowiecki | 05 825 | Poland |
| Centrum Medyczne Plejady | Krakow | 30 363 | Poland |
| Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k. | Poznan | 60-848 | Poland |
| Centrum Medyczne Pratia Poznan | Skorzewo | 60 185 | Poland |
| MICS Centrum Medyczne Warszawa | Warsaw | 00 874 | Poland |
| Klinika Reuma Park Sp zoo Sp K | Warsaw | 02 665 | Poland |
| Narodowy Instytut Geriatrii | Warsaw | 02637 | Poland |
| FutureMeds sp zoo | Wroclaw | 50 088 | Poland |
| Lack of Efficacy |
|
| Protocol Violation |
|
| Personal reason |
|
| Placebo-Efgartigimod |
Participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study. This reporting group presents the participants who received placebo in the parent study (ARGX-113-2106). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|
| OG000 | Efgartigimod-Efgartigimod | Participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study. This reporting group presents the participants who also received efgartigimod in the parent study (ARGX-113-2106). |
| OG001 | Placebo-Efgartigimod | Participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study. This reporting group presents the participants who received placebo in the parent study (ARGX-113-2106). |
|
|
| Secondary | Number of CRESS Responders at 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. | The FAS included all enrolled participants. | Posted | Count of Participants | Participants | Weeks 24 and 48 |
|
|
|
| Secondary | Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSDAI at 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. | The FAS included all enrolled participants. | Posted | Count of Participants | Participants | Baseline (Day 1) and Weeks 24 and 48 |
|
|
|
| Secondary | Number of Participants With Low Disease Activity in ESSDAI at 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. | The FAS included all enrolled participants. | Posted | Count of Participants | Participants | Weeks 24 and 48 |
|
|
|
| Secondary | Number of Participants With Minimal Clinically Important Improvement From Baseline in clinESSDAI at 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. | The FAS included all enrolled participants. | Posted | Count of Participants | Participants | Baseline (Day 1) and Weeks 24 and 48 |
|
|
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| Secondary | Number of Participants With Low Disease Activity in clinESSDAI at 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. | The FAS included all enrolled participants. | Posted | Count of Participants | Participants | Weeks 24 and 48 |
|
|
|
| Secondary | Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSPRI at 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. | The FAS included all enrolled participants. | Posted | Count of Participants | Participants | Baseline (Day 1) and Weeks 24 and 48 |
|
|
|
| Secondary | Change From Baseline in ESSDAI Score at 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. | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | Posted | Median | Full Range | score on a scale | Baseline (Day 1) and Weeks 24 and 48 |
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|
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| Secondary | Change From Baseline in clinESSDAI Score at 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. | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | Posted | Median | Full Range | score on a scale | Baseline (Day 1) and Weeks 24 and 48 |
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|
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| Secondary | Change From Baseline in ESSPRI Score at 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. | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | Posted | Median | Full Range | score on a scale | Baseline (Day 1) and Weeks 24 and 48 |
|
|
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| Secondary | Number of STAR Responders at Weeks 24 and 48 | Sjögren's tool for assessing response (STAR) is a composite endpoint assessing multiple clinically relevant disease features. A STAR responder is defined as a participant with a score of at least 5 points. Due to the weighting, participant must be a responder on either systemic disease activity (ESSDAI), patient-reported symptoms (ESSPRI), or both to be an overall STAR responder. The score ranges between 0 and 9 (higher score = worse outcome). 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. | The FAS included all enrolled participants. | Posted | Count of Participants | Participants | Weeks 24 and 48 |
|
|
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| Secondary | Percent Change From Baseline in Total IgG Levels in Serum at Week 48 | Blood samples were collected at indicated timepoints to assess the total Immunoglobulin (Ig)G levels in serum. Total IgG concentrations were quantified using validated methods at a diagnostical laboratory. Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106. | The FAS included all enrolled participants. Only those participants with data collected at Baseline and Week 48 are reported. | Posted | Mean | Standard Deviation | percent change | Baseline (Day 1) and Week 48 |
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|
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| Secondary | Percent Change From Baseline in Autoantibodies in Serum at Week 48 | Blood samples were collected at indicated timepoints to assess serum autoantibodies: anti-Ro/Sjögren's syndrome-related antigen A (SS-A) and anti-La/Sjögren's syndrome-related antigen B (SS-B). Baseline was defined as the last available non-missing measurement from the parent study ARGX-113-2106. | The FAS included all enrolled participants. Only those participants with data collected at Baseline and Week 48 are reported. | Posted | Mean | Standard Deviation | percent change | Baseline (Day 1) and Week 48 |
|
|
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| Secondary | Serum Concentrations of Efgartigimod | Serum samples were collected at indicated timepoints to assess the pharmacokinetic (PK) profile of efgartigimod. | The PK analysis set included all enrolled participants who received at least 1 dose of efgartigimod and had at least 1 measured concentration of efgartigimod at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentration. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | Posted | Mean | Standard Deviation | microgram/milliliter (mcg/mL) | Pre-dose and post-dose at Baseline (Day 1) and pre-dose at Weeks 24 and 48 |
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| Secondary | Number of Participants With ADA Against Efgartigimod Over the 48-week Treatment Period | Blood samples were collected to assess anti-drug antibodies (ADAs) against efgartigimod. Samples were analyzed by the designated laboratory in a 3-tiered approach using validated immunogenicity assays. ADA incidence included total number of participants with treatment-boosted and treatment-induced ADA. Treatment-boosted ADA was defined as participants who had a baseline positive sample and the titer value increased 4-fold or more compared to baseline. Treatment-induced ADA was defined as participants who had a baseline negative sample and at least 1 positive post-baseline samples. Number of participants with ADA incidence is presented here. | The SAF included all FAS participants who had been administered at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | From Baseline (Day 1) up to 48 weeks |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 15 |
| 17 |
| EG001 | Placebo-Efgartigimod | Participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study. This reporting group presents the participants who received placebo in the parent study (ARGX-113-2106). | 0 | 7 | 2 | 7 | 6 | 7 |
| Eye irritation | Eye disorders | MedDRA 27.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 27.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 27.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Gastric antral vascular ectasia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Parotid gland enlargement | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Salivary gland pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Joint hyperextension | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Lower respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
Not provided
Not provided
| Week 48 |
|
|
| Week 48 |
|
|
| Week 48 |
|
|
| Baseline, post-dose |
|
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| Week 24, pre-dose |
|
|
| Week 48, pre-dose |
|
|