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Due to the phase 2 results of the main study (ARGX-113-2104) showing that efgartigimod-treated PC-POTS patients had no clinically meaningful improvement, the decision has been made to terminate this open-label extension study (ARGX-113-2105) study.
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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with post-COVID-19 postural orthostatic.
Study ARGX-113-2105 is a long-term, single-arm, open-label, multicenter extension of the ARGX-113-2104 study, designed to evaluate the long-term safety of efgartigimod IV in adult patients with PC-POTS. Participants will be enrolled from both active and placebo arms of the ARGX-113-2104 study and will receive efgartigimod IV 10 mg/kg in the extension study without knowledge of their prior treatment arm. To be eligible to enroll in this study, participants must have completed the 24-week treatment period of the ARGX-113-2104 study and must not have permanently discontinued the IMP in that study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efgartigimod | Experimental | Receive efgartigimod IV 10mg/kg infusions during a treatment period of 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod | Drug | Participants will receive efgartigimod IV 10 mg/kg open label, respectively. |
|
| 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. An adverse event of special interest (AESI) was an AE of scientific and medical concern specific to the sponsor's product or program. 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. | From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Weeks 24 and 48 in the COMPASS 31 (2-week Recall Version) | Composite Autonomic Symptom Score (COMPASS) 31 modified version (2-week recall) is a self-rated questionnaire to evaluate the severity and distribution of autonomic symptoms in various autonomic nerve disorders. It consists of 31 questions in 6 weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal {GI}-mixed upper and diarrhea, bladder, and pupillomotor). A weighted total score of 0 (mild) to 100 (severe) was determined by adding a maximum raw score for each domain. Higher scores indicated a more severe degree of autonomic symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Sand Diego Sulpizio Cardiovascular Center | La Jolla | California | 92037 | United States | ||
| Standford Movement Disorder Center |
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A total of 33 participants were rolled over from both active (efgartigimod) and placebo arms of the parent study ARGX-113-2104 (NCT05633407) to receive efgartigimod in this study. This study was terminated not for safety concerns but because the parent study found that efgartigimod intravenous (IV) provided no efficacy benefit in adult participants with PC-POTS.
This open-label study was an extension of ARGX-113-2104 study (NCT05633407) and was conducted at 9 sites in the United States from 26-Jun-23 to 15-Aug-24 in participants with post-coronavirus disease 2019 (COVID-19) postural orthostatic tachycardia syndrome (PC-POTS).
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| ID | Title | Description |
|---|---|---|
| FG000 | Efgartigimod-Efgartigimod | Participants who received efgartigimod in parent study continued to receive efgartigimod 10 milligram/kilogram (mg/kg) via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period). |
| FG001 |
| 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 | Feb 23, 2024 | Aug 4, 2025 |
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| Baseline (Day 1) and Weeks 24 and 48 |
| Change From Baseline to Weeks 24 and 48 in the MaPS | The Malmö POTS Symptom Score (MaPS) score is a dedicated POTS symptom scoring questionnaire. The score consists of 12 questions that assess symptom burden related (tachycardia, palpitations, dizziness, presyncope) and unrelated to orthostatic intolerance (GI symptoms, insomnia, concentration difficulties). Participants graded their symptoms for the past 7 days using a numerical rating scale ranging from 0 (no symptoms) to 10 (very pronounced symptoms). The total score was calculated by summing up the items/individual items and range was 0 to 120 points, with higher scores indicating more severe symptoms. | Baseline (Day 1) and Weeks 24 and 48 |
| Percentage of Participants With Improved PGI-S at Weeks 24 and 48 | The Patient Global Impression-Severity (PGI-S) is a participant-rated, single-item scale to assess the severity of a health condition. The scale was used to assess the severity of symptoms over the past week (1-week recall) and overall experience of symptoms over the past 2 weeks (2-week recall). Both were rated on a 4-point type Likert scale, with scores ranging from 1 (none), 2 (mild), 3 (moderate), and 4 (severe). Higher scores indicate greater symptom severity. An "improved PGI-S" was defined by a change from baseline of -3, -2 and -1. | Baseline (Day 1) and Weeks 24 and 48 |
| Percentage of Participants With Improved PGI-C at Weeks 24 and 48 | The Patient Global Impression-Change (PGIC) is a single-item scale to capture the participant's perception of an overall change in their symptoms from start of study drug. It was rated on a 7-point Likert scale, with scores ranging from 1 (much better), 2 (somewhat better), 3 (a little better), 4 (no change), 5 (a little worse), 6 (somewhat worse), and 7 (much worse). Higher PGI-C scores signify worse outcome. An "improved PGI-C" was defined by a change from baseline of 1, 2 and 3. | Baseline (Day 1) and Weeks 24 and 48 |
| Change From Baseline to Weeks 24 and 48 in the PROMIS Fatigue Short Form 8a | The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a assesses the impact and perceived fatigue during the last 7 days. This validated 8-question scale has 5 response options, with scores ranging from 1 (not at all) to 5 (very much). Total scores ranged from 8 to 40; higher scores indicated higher fatigue levels and were converted to a T-score with a mean of 50 and standard deviation of 10. A decrease in T-score (negative change from baseline) indicated improvement in fatigue. | Baseline (Day 1) and Weeks 24 and 48 |
| Change From Baseline to Weeks 24 and 48 in the PROMIS Cognitive Function Short Form 6a | PROMIS Cognitive Function Short Form 6a assesses the frequency of cognitive difficulties experienced in the past 7 days. The questionnaire comprises 6 questions on subjective cognitive difficulties regarding a participant's concentration, memory, language, mental acuity, and perceived changes in cognitive functioning. The participant marks their response on a 5-point Likert scale (1: never and 5: very often). Scores ranged from 6 to 30; higher scores indicated worse perceived cognitive functioning and were converted to a T-score with a mean of 50 and standard deviation of 10. An increase in T-score (positive change from baseline) indicated better cognitive function. | Baseline (Day 1) and Weeks 24 and 48 |
| Percent Change From Baseline in Total IgG Levels at Weeks 24 and 48 | Blood samples for immunoglobulin G (IgG) analysis were collected at specified time points. Total IgG concentrations were quantified using validated methods at a central laboratory. | Baseline (Day 1) and Weeks 24 and 48 |
| Serum Concentration of Efgartigimod | Serum samples were collected at specified timepoints to determine the concentration of efgartigimod. | Pre-dose at Baseline (Day 1) and Weeks 1, 4, 12 and 24 |
| Number of Participants With ADAs Against Efgartigimod | Blood samples were collected at specified timepoints to assess anti-drug antibodies (ADAs) against efgartigimod. ADA incidence reported here was defined as total number of participants with treatment-induced and treatment-boosted ADA. Treatment-induced ADA was defined as a baseline negative sample and at least 1 positive post-baseline sample. Treatment-boosted ADA was defined as a baseline positive sample and the titer value increased 4-fold or more compared to baseline. | From the first dose of study drug (Day 1) up to Week 48 |
| Palo Alto |
| California |
| 94304 |
| United States |
| North Shore University HealthSystem | Glenview | Illinois | 60026 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University Hospitals, Neurology Clinical Trials | Cleveland | Ohio | 44106 | United States |
| Apex Trials Group | Fort Worth | Texas | 76104 | United States |
| Pioneer Clinical Research | Rosharon | Texas | 77583 | United States |
| Metrodora Institute | West Valley City | Utah | 84119 | United States |
| Placebo-Efgartigimod |
Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis was performed on full analysis set (FAS) which included all enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Efgartigimod-Efgartigimod | Participants who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period). |
| BG001 | Placebo-Efgartigimod | Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| 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. An adverse event of special interest (AESI) was an AE of scientific and medical concern specific to the sponsor's product or program. 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. | The safety analysis set (SAF) included all enrolled participants exposed to study drug. | Posted | Count of Participants | Participants | No | From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Weeks 24 and 48 in the COMPASS 31 (2-week Recall Version) | Composite Autonomic Symptom Score (COMPASS) 31 modified version (2-week recall) is a self-rated questionnaire to evaluate the severity and distribution of autonomic symptoms in various autonomic nerve disorders. It consists of 31 questions in 6 weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal {GI}-mixed upper and diarrhea, bladder, and pupillomotor). A weighted total score of 0 (mild) to 100 (severe) was determined by adding a maximum raw score for each domain. Higher scores indicated a more severe degree of autonomic symptoms. | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and Weeks 24 and 48 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Weeks 24 and 48 in the MaPS | The Malmö POTS Symptom Score (MaPS) score is a dedicated POTS symptom scoring questionnaire. The score consists of 12 questions that assess symptom burden related (tachycardia, palpitations, dizziness, presyncope) and unrelated to orthostatic intolerance (GI symptoms, insomnia, concentration difficulties). Participants graded their symptoms for the past 7 days using a numerical rating scale ranging from 0 (no symptoms) to 10 (very pronounced symptoms). The total score was calculated by summing up the items/individual items and range was 0 to 120 points, with higher scores indicating more severe symptoms. | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and Weeks 24 and 48 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improved PGI-S at Weeks 24 and 48 | The Patient Global Impression-Severity (PGI-S) is a participant-rated, single-item scale to assess the severity of a health condition. The scale was used to assess the severity of symptoms over the past week (1-week recall) and overall experience of symptoms over the past 2 weeks (2-week recall). Both were rated on a 4-point type Likert scale, with scores ranging from 1 (none), 2 (mild), 3 (moderate), and 4 (severe). Higher scores indicate greater symptom severity. An "improved PGI-S" was defined by a change from baseline of -3, -2 and -1. | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | Posted | Number | percentage of participants | Baseline (Day 1) and Weeks 24 and 48 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improved PGI-C at Weeks 24 and 48 | The Patient Global Impression-Change (PGIC) is a single-item scale to capture the participant's perception of an overall change in their symptoms from start of study drug. It was rated on a 7-point Likert scale, with scores ranging from 1 (much better), 2 (somewhat better), 3 (a little better), 4 (no change), 5 (a little worse), 6 (somewhat worse), and 7 (much worse). Higher PGI-C scores signify worse outcome. An "improved PGI-C" was defined by a change from baseline of 1, 2 and 3. | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | Posted | Number | percentage of participants | Baseline (Day 1) and Weeks 24 and 48 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Weeks 24 and 48 in the PROMIS Fatigue Short Form 8a | The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a assesses the impact and perceived fatigue during the last 7 days. This validated 8-question scale has 5 response options, with scores ranging from 1 (not at all) to 5 (very much). Total scores ranged from 8 to 40; higher scores indicated higher fatigue levels and were converted to a T-score with a mean of 50 and standard deviation of 10. A decrease in T-score (negative change from baseline) indicated improvement in fatigue. | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | Posted | Mean | Standard Deviation | T-score | Baseline (Day 1) and Weeks 24 and 48 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Weeks 24 and 48 in the PROMIS Cognitive Function Short Form 6a | PROMIS Cognitive Function Short Form 6a assesses the frequency of cognitive difficulties experienced in the past 7 days. The questionnaire comprises 6 questions on subjective cognitive difficulties regarding a participant's concentration, memory, language, mental acuity, and perceived changes in cognitive functioning. The participant marks their response on a 5-point Likert scale (1: never and 5: very often). Scores ranged from 6 to 30; higher scores indicated worse perceived cognitive functioning and were converted to a T-score with a mean of 50 and standard deviation of 10. An increase in T-score (positive change from baseline) indicated better cognitive function. | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | Posted | Mean | Standard Deviation | T-score | Baseline (Day 1) and Weeks 24 and 48 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total IgG Levels at Weeks 24 and 48 | Blood samples for immunoglobulin G (IgG) analysis were collected at specified time points. Total IgG concentrations were quantified using validated methods at a central laboratory. | The SAF included all enrolled participants exposed to study drug. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | Posted | Mean | Standard Deviation | percent change | Baseline (Day 1) and Weeks 24 and 48 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Efgartigimod | Serum samples were collected at specified timepoints to determine the concentration of efgartigimod. | The pharmacokinetic analysis set (PKAS) 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 specified timepoints are reported. | Posted | Mean | Standard Deviation | microgram/milliliter (mcg/mL) | Pre-dose at Baseline (Day 1) and Weeks 1, 4, 12 and 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With ADAs Against Efgartigimod | Blood samples were collected at specified timepoints to assess anti-drug antibodies (ADAs) against efgartigimod. ADA incidence reported here was defined as total number of participants with treatment-induced and treatment-boosted ADA. Treatment-induced ADA was defined as a baseline negative sample and at least 1 positive post-baseline sample. Treatment-boosted ADA was defined as a baseline positive sample and the titer value increased 4-fold or more compared to baseline. | The SAF included all enrolled participants exposed to study drug. | Posted | Count of Participants | Participants | No | From the first dose of study drug (Day 1) up to Week 48 |
|
From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days
Analysis was performed on the SAF. Laboratory abnormalities were reported as AEs.
Not provided
| 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 who received efgartigimod in parent study continued to receive efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period). | 0 | 20 | 0 | 20 | 13 | 20 |
| EG001 | Placebo-Efgartigimod | Participants who received placebo in parent study received efgartigimod 10 mg/kg via IV infusion from Day 1 once a week for the first 4 weeks (induction dosing period) and then once every 2 weeks for 42 weeks (maintenance dosing period). | 0 | 13 | 0 | 13 | 12 | 13 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | 27.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | 27.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | 27.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 27.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | 27.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Energy increased | General disorders | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 27.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| Contrast media reaction | Immune system disorders | 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Gastrointestinal bacterial overgrowth | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Nerve injury | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Vascular access site pain | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time shortened | Investigations | 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | 27.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Weight increased | Investigations | 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Skin tightness | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Vasodilatation | Vascular disorders | 27.0 | Systematic Assessment |
|
This study was terminated not for safety concerns but because the parent study found that efgartigimod IV provided no efficacy benefit in adult participants with PC-POTS.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Manager | argenx BVBA | +32 93103400 | regulatory@argenx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 3, 2024 | Aug 4, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000718373 | efgartigimod alfa |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| TEAESIs |
|
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| Units | Counts |
|---|---|
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| Units | Counts |
|---|---|
| Participants |
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