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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005911-30 | EudraCT Number |
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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.
Primary Sjogren Syndrome (pSS) is an autoimmune disease with still unmet treatment needs. Efgartigimod, a human FcRn antagonist, has the potential to successfully treat pSS and improve disease manifestations by the reduction of IgG autoantibodies and immune complexes in pSS. The study design is randomized, double-blinded, and placebo-controlled to evaluate the effect of efgartigimod administered as an IV infusion compared to placebo. The study consists of a treatment period when all participants will receive infusions of IP/placebo for 24 weeks. At the end of the randomized treatment period, eligible participants may roll over to an OLE study or remain in this study through the end of the 56-day follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efgartigimod IV arm | Experimental | patients receiving infusions of Efgartigimod IV |
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| Placebo arm | Placebo Comparator | patients receiving infusions of placebo IV |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod | Biological | Patients receiving efgartigimod infusions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at 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). | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With TEAEs, AESI, and SAEs | 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'. |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41997805 | Derived | Peene I, Verstappen GM, Arends S, Kroese FGM, De Boeck K, Achten H, Papadopoulou D, Jacobs J, Bowen E, Teperov E, Meyvisch P, Fardipour P, Kelly A, Brahmbhatt J, Elewaut D, Bootsma H. Efgartigimod in Sjogren's disease: a phase 2, randomised, placebo-controlled, parallel-group, double-blinded, proof-of-concept study (RHO). Ann Rheum Dis. 2026 Apr 16:S0003-4967(26)00205-0. doi: 10.1016/j.ard.2026.03.019. Online ahead of print. |
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A total of 34 participants were enrolled in the study. The study consisted of screening (≤4 weeks), treatment period (24 weeks), and follow-up period (56 days). Participants were randomized in a 2:1 ratio to either receive efgartigimod or placebo for 24 weeks. At the end of treatment period, eligible participants rolled over to an open-label extension (OLE) study (ARGX-113-2211 [NCT06203457]) or remained in the study for the post-treatment follow-up period.
This Phase 2, double-blinded study was conducted in adult participants with primary Sjögren's disease (pSjD) at 15 investigational sites in 3 countries (Belgium, Hungary, and Poland) between 08-May-2023 and 12-Feb-2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Efgartigimod | Participants received efgartigimod 10 milligram per kilogram (mg/kg) once weekly via intravenous (IV) infusion for up to 24 weeks. |
| FG001 | Placebo | Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Dec 5, 2022 | Jun 25, 2025 |
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Participants will be randomized to receive efgartigimod 10 mg/kg or placebo in a 2:1 ratio, respectively. All participants will receive efgartigimod IV 10 mg/kg or placebo once weekly for 24 weeks during the treatment period
| Placebo |
| Biological |
Patients receiving placebo infusions |
|
| Up to 32 weeks |
| Percentage of Participants With MCII in ESSDAI at 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. | Week 24 |
| Percentage of Participants With Low Disease Activity in ESSDAI at 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. | Week 24 |
| Percentage of Participants With MCII in clinESSDAI at 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. | Week 24 |
| Percentage of Participants With Low Disease Activity in clinESSDAI at 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. | Week 24 |
| Percentage of Participants With MCII in ESSPRI at 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). | Week 24 |
| Change From Baseline in ESSDAI Score at 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). | Baseline (Day 1) and Week 24 |
| Change From Baseline in clinESSDAI Score at 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). | Baseline (Day 1) and Week 24 |
| Change From Baseline in ESSPRI Score 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). | Baseline (Day 1) and Week 24 |
| Percentage of Participants With STAR Score of at Least 5 at Week 24 | Sjögren's Tool for Assessing Response (STAR) is a composite endpoint assessing multiple clinically relevant disease features. A STAR responder is defined as a score of at least 5 points. Due to the weighting, participants 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). | Week 24 |
| Plasma Concentration of Efgartigimod | Serum samples were collected at indicated time points to assess the pharmacokinetic (PK) profile of efgartigimod. | Pre-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, and 20; 30 minutes post-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
| Percentage Change From Baseline in Total IgG Levels in Serum at Week 24 | Blood samples were collected at indicated timepoints to assess the total Immunoglobulin (Ig)G levels in serum. | Baseline (Day 1) and Week 24 |
| Number of Participants With ADA Against Efgartigimod in Serum | Blood samples were collected to assess anti-drug antibodies (ADAs) against efgartigimod. 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. Treatment-unaffected ADA was defined as participants who had a baseline positive sample, but the titer value did not increase 4-fold or more compared to baseline. | Up to Week 24 |
| Debrecen |
| 4032 |
| Hungary |
| Vita Verum Medical Egeszsegugyi Szolgaltato Bt. | Székesfehérvár | 8000 | Hungary |
| Universitair Medisch Centrum Groningen , Dept of Rheumatology and Clinical Immunology | Groningen | 9713 GZ | Netherlands |
| Ambulatorium Barbara Bazela | Elblag | 82-300 | Poland |
| MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C. | Grodzisk Mazowiecki | 05-825 | Poland |
| Centrum Medyczne Plejady | Krakow | 30-363 | Poland |
| FutureMeds Krakow | Krakow | 31-501 | Poland |
| ETG Lublin | Lublin | 20-412 | Poland |
| Reumed Spolka z o.o. | Lublin | 20-607 | Poland |
| Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k. | Poznan | 60-848 | Poland |
| Centrum Medyczne Pratia Poznan | Skórzewo | 60-185 | Poland |
| MICS Centrum Medyczne Warszawa | Warsaw | 00-874 | Poland |
| KO-Med - Centrum Badań Medycznych NIGRiR | Warsaw | 02-637 | Poland |
| Centrum Medyczne Reuma Park | Warsaw | 02-691 | Poland |
| FutureMeds Targowek | Warsaw | 03-291 | Poland |
| FutureMeds Wroclaw | Wroclaw | 50-088 | Poland |
| COMPLETED | Completed 24-week treatment period |
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| NOT COMPLETED |
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Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment and who were classified according to the planned treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Efgartigimod | Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks. |
| BG001 | Placebo | Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at 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). | The Efficacy Analysis Set (EAS) included all participants eligible for efficacy evaluation. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Number of Participants With TEAEs, AESI, and SAEs | 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'. | The Safety Analysis Set (SAF) included all participants exposed to the study treatment. | Posted | Count of Participants | Participants | No | Up to 32 weeks |
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| Secondary | Percentage of Participants With MCII in ESSDAI at 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. | EAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With Low Disease Activity in ESSDAI at 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. | EAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With MCII in clinESSDAI at 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. | EAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With Low Disease Activity in clinESSDAI at 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. | EAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With MCII in ESSPRI at 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). | EAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Change From Baseline in ESSDAI Score at 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). | EAS - Only participants with data collected at baseline and Week 24 are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline (Day 1) and Week 24 |
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| Secondary | Change From Baseline in clinESSDAI Score at 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). | EAS - Only participants with data collected at baseline and Week 24 are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline (Day 1) and Week 24 |
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| Secondary | Change From Baseline in ESSPRI Score 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). | EAS - Only participants with data collected at Baseline and Week 24 are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline (Day 1) and Week 24 |
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| Secondary | Percentage of Participants With STAR Score of at Least 5 at Week 24 | Sjögren's Tool for Assessing Response (STAR) is a composite endpoint assessing multiple clinically relevant disease features. A STAR responder is defined as a score of at least 5 points. Due to the weighting, participants 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). | EAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Plasma Concentration of Efgartigimod | Serum samples were collected at indicated time points to assess the pharmacokinetic (PK) profile of efgartigimod. | PK population included all randomized participants who received at least 1 dose of efgartigimod and had at least 1 measured concentration of efgartigimod at a scheduled PK time point. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | Pre-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, and 20; 30 minutes post-dose at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24 |
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| Secondary | Percentage Change From Baseline in Total IgG Levels in Serum at Week 24 | Blood samples were collected at indicated timepoints to assess the total Immunoglobulin (Ig)G levels in serum. | SAF - Only participants with data available at baseline and Week 24 are reported. | Posted | Mean | Standard Deviation | Percentage change | Baseline (Day 1) and Week 24 |
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| Secondary | Number of Participants With ADA Against Efgartigimod in Serum | Blood samples were collected to assess anti-drug antibodies (ADAs) against efgartigimod. 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. Treatment-unaffected ADA was defined as participants who had a baseline positive sample, but the titer value did not increase 4-fold or more compared to baseline. | SAF. | Posted | Count of Participants | Participants | No | Up to Week 24 |
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Up to 32 weeks.
The SAF included all participants exposed to the study treatment. Any abnormal laboratory results or changes in vital signs are captured in the adverse event listings.
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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 | Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks. | 0 | 23 | 1 | 23 | 20 | 23 |
| EG001 | Placebo | Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks. | 0 | 11 | 0 | 11 | 7 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasospasm | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Motion sickness | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Peptic ulcer | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Purpura | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory manager | Argenx | Please email: | regulatory@argenx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 12, 2024 | Jun 25, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000718373 | efgartigimod alfa |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Unknown |
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