Primary Sjögren's Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALEfgartigimod
Patients receiving efgartigimod infusions
BIOLOGICALPlacebo
Patients receiving placebo infusions
Sponsors
Iqvia Pty Ltd
argenx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least the legal age of consent for clinical trials when signing the informed consent form * Is capable of providing signed informed consent and complying with protocol requirements * Agrees to use contraceptive measures consistent with local regulations and measures described in the protocol * Meets the following criteria at screening: ACR/EULAR 2016 pSS who met criteria ≤7 years before screening; ESSDAI ≥5; Anti-Ro/SS-A positive; Residual salivary flow (UWSF rate \>0 and/or SWSF rate \>0.10)
Exclusion criteria
* Known autoimmune disease or any medical condition that, in the investigator's judgment,would interfere with an accurate assessment of clinical symptoms of pSS or puts the participant at undue risk * History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP. * Adequately treated participants with the following cancers may be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b) Clinically significant uncontrolled active acute or chronic bacterial, viral, or fungal infection * Positive serum test at screening for an active infection with any of the following: HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available; HIV based on test results of a CD4 count of \<200 cells/mm3 that are associated with an AIDS-defining condition, HIV based on test results of a CD4 count of \>200 cells/mm3 not adequately treated with antiviral therapy * Clinically significant disease, recent major surgery (within 3 months of screening), or intention to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk * Immunoglobulin G (IgG) levels cannot be below a certain threshold ( 4g/L) * Positive covid test at study start * Some of the medications such as vaccines with live components or medicines that may be prescribed cannot be taken either shortly before or during this study * Current participation in another interventional clinical study or previously participation in an efgartigimod clinical study and treatment with ≥1 dose of IMP * Known hypersensitivity to IMP or 1 of its excipients * History (within 12 months of screening) of current alcohol, drug, or medication abuse as assessed by the investigator * Pregnant or lactating state or intention to become pregnant during the study * Secondary Sjögren's syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition is the primary diagnosis * Chinese traditional medicine with known immunomodulatory action
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24 | Week 24 | A Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) responder is defined as improvements in at least 3 of the 5 items of CRESS (systemic disease activity, patient-reported symptoms, tear gland function, salivary gland function and serology. The score ranges from 0 to 9 (higher score = worse symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With MCII in ESSDAI at Week 24 | Week 24 | European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score =worse symptoms). Minimally clinically important improvement (MCII) in ESSDAI was defined as improvement of at least 3 points in ESSDAI score at Week 24. |
| Percentage of Participants With Low Disease Activity in ESSDAI at Week 24 | Week 24 | ESSDAI measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score =worse symptoms). Low disease activity in ESSDAI was defined as ESSDAI score of less than 5 at Week 24. |
| Percentage of Participants With MCII in clinESSDAI at Week 24 | Week 24 | Clinical (clin)ESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). Minimal clinically important improvement (MCII) in clinESSDAI was defined as improvement of at least 3 points in clinESSDAI score at Week 24. |
| Percentage of Participants With Low Disease Activity in clinESSDAI at Week 24 | Week 24 | clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). Low disease activity in clinESSDAI was defined as clinESSDAI score of less than 5 at Week 24. |
| Percentage of Participants With MCII in ESSPRI at Week 24 | Week 24 | Minimal clinically important improvement in ESSPRI was defined as decrease of 1 point or at least ≥15% at Week 24. ESSPRI is a questionnaire that has been developed to measure self-reported symptoms in participants with pSjD. The score ranges from 0 (no symptoms) to 10 (more symptoms). |
| Change From Baseline in ESSDAI Score at Week 24 | Baseline (Day 1) and Week 24 | ESSDAI measures systemic disease activity in participants with pSjD and consists of 11 organ-specific domains and 1 biological domain that contribute to disease activity level scoring. Each domain is given a certain weight, which gives a score between 0 and 123 (higher score = worse symptoms). |
| Number of Participants With TEAEs, AESI, and SAEs | Up to 32 weeks | A treatment-emergent adverse event (TEAE): adverse events reported from the first dose up to and including 60 days after the final dose were considered treatment-emergent. Serious adverse event (SAE): adverse event that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or other situations. Adverse event of special interest (AESI): adverse event related to 'Infections and infestations'. |
| Change From Baseline in ESSPRI Score at Week 24 | Baseline (Day 1) and Week 24 | ESSPRI is a questionnaire that has been developed to measure self-reported symptoms in participants with pSjD. The score ranges from 0 (no symptoms) to 10 (more symptoms). |
| Percentage of Participants With STAR Score of at Least 5 at Week 24 | 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). |
| Plasma Concentration 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 | Serum samples were collected at indicated time points to assess the pharmacokinetic (PK) profile of efgartigimod. |
| Percentage Change From Baseline in Total IgG Levels in Serum at Week 24 | Baseline (Day 1) and Week 24 | Blood samples were collected at indicated timepoints to assess the total Immunoglobulin (Ig)G levels in serum. |
| Number of Participants With ADA Against Efgartigimod in Serum | Up to Week 24 | 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. |
| Change From Baseline in clinESSDAI Score at Week 24 | Baseline (Day 1) and Week 24 | clinESSDAI includes the same 11 organ-specific domains as ESSDAI but with different domain weighting and without the biological domain. This way any change in clinESSDAI score would reflect disease specific features, irrespective of B-cell activity. The clinESSDAI score ranges between 0-135 (higher score = worse symptoms). |
Countries
Belgium, Hungary, Netherlands, Poland
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Efgartigimod Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks. | 23 |
| Placebo Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks. | 11 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Prohibited medication used | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | Efgartigimod |
|---|---|---|---|
| Age, Continuous | 54.7 Years STANDARD_DEVIATION 12.42 | 51.6 Years STANDARD_DEVIATION 12.52 | 50.1 Years STANDARD_DEVIATION 12.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 33 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 11 Participants | 33 Participants | 22 Participants |
| Sex: Female, Male Female | 11 Participants | 33 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 11 |
| other Total, other adverse events | 20 / 23 | 7 / 11 |
| serious Total, serious adverse events | 1 / 23 | 0 / 11 |
Outcome results
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).
Time frame: Week 24
Population: The Efficacy Analysis Set (EAS) included all participants eligible for efficacy evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Efgartigimod | Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24 | 45.5 Percentage of participants |
| Placebo | Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24 | 11.1 Percentage of participants |
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).
Time frame: Baseline (Day 1) and Week 24
Population: EAS - Only participants with data collected at baseline and Week 24 are reported.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Efgartigimod | Change From Baseline in clinESSDAI Score at Week 24 | -7.0 score on a scale |
| Placebo | Change From Baseline in clinESSDAI Score at Week 24 | -4.0 score on a scale |
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).
Time frame: Baseline (Day 1) and Week 24
Population: EAS - Only participants with data collected at baseline and Week 24 are reported.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Efgartigimod | Change From Baseline in ESSDAI Score at Week 24 | -5.0 score on a scale |
| Placebo | Change From Baseline in ESSDAI Score at Week 24 | -4.0 score on a scale |
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).
Time frame: Baseline (Day 1) and Week 24
Population: EAS - Only participants with data collected at Baseline and Week 24 are reported.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Efgartigimod | Change From Baseline in ESSPRI Score at Week 24 | -0.500 score on a scale |
| Placebo | Change From Baseline in ESSPRI Score at Week 24 | -0.833 score on a scale |
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.
Time frame: Up to Week 24
Population: SAF.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Efgartigimod | Number of Participants With ADA Against Efgartigimod in Serum | Treatment-unaffected ADA | 11 Participants |
| Efgartigimod | Number of Participants With ADA Against Efgartigimod in Serum | Treatment-boosted ADA | 1 Participants |
| Efgartigimod | Number of Participants With ADA Against Efgartigimod in Serum | Treatment-induced ADA | 2 Participants |
| Placebo | Number of Participants With ADA Against Efgartigimod in Serum | Treatment-boosted ADA | 0 Participants |
| Placebo | Number of Participants With ADA Against Efgartigimod in Serum | Treatment-induced ADA | 0 Participants |
| Placebo | Number of Participants With ADA Against Efgartigimod in Serum | Treatment-unaffected ADA | 3 Participants |
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'.
Time frame: Up to 32 weeks
Population: The Safety Analysis Set (SAF) included all participants exposed to the study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Efgartigimod | Number of Participants With TEAEs, AESI, and SAEs | Any TEAE | 20 Participants |
| Efgartigimod | Number of Participants With TEAEs, AESI, and SAEs | Any AESI | 15 Participants |
| Efgartigimod | Number of Participants With TEAEs, AESI, and SAEs | Any SAE | 1 Participants |
| Placebo | Number of Participants With TEAEs, AESI, and SAEs | Any TEAE | 7 Participants |
| Placebo | Number of Participants With TEAEs, AESI, and SAEs | Any AESI | 5 Participants |
| Placebo | Number of Participants With TEAEs, AESI, and SAEs | Any SAE | 0 Participants |
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.
Time frame: Baseline (Day 1) and Week 24
Population: SAF - Only participants with data available at baseline and Week 24 are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Efgartigimod | Percentage Change From Baseline in Total IgG Levels in Serum at Week 24 | -57.172 Percentage change | Standard Deviation 17.7376 |
| Placebo | Percentage Change From Baseline in Total IgG Levels in Serum at Week 24 | 0.279 Percentage change | Standard Deviation 9.5193 |
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.
Time frame: Week 24
Population: EAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Efgartigimod | Percentage of Participants With Low Disease Activity in clinESSDAI at Week 24 | 59.1 Percentage of participants |
| Placebo | Percentage of Participants With Low Disease Activity in clinESSDAI at Week 24 | 33.3 Percentage of participants |
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.
Time frame: Week 24
Population: EAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Efgartigimod | Percentage of Participants With Low Disease Activity in ESSDAI at Week 24 | 59.1 Percentage of participants |
| Placebo | Percentage of Participants With Low Disease Activity in ESSDAI at Week 24 | 22.2 Percentage of participants |
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.
Time frame: Week 24
Population: EAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Efgartigimod | Percentage of Participants With MCII in clinESSDAI at Week 24 | 77.3 Percentage of participants |
| Placebo | Percentage of Participants With MCII in clinESSDAI at Week 24 | 77.8 Percentage of participants |
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.
Time frame: Week 24
Population: EAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Efgartigimod | Percentage of Participants With MCII in ESSDAI at Week 24 | 72.7 Percentage of participants |
| Placebo | Percentage of Participants With MCII in ESSDAI at Week 24 | 55.6 Percentage of participants |
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).
Time frame: Week 24
Population: EAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Efgartigimod | Percentage of Participants With MCII in ESSPRI at Week 24 | 31.8 Percentage of participants |
| Placebo | Percentage of Participants With MCII in ESSPRI at Week 24 | 33.3 Percentage of participants |
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).
Time frame: Week 24
Population: EAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Efgartigimod | Percentage of Participants With STAR Score of at Least 5 at Week 24 | 54.5 Percentage of participants |
| Placebo | Percentage of Participants With STAR Score of at Least 5 at Week 24 | 33.3 Percentage of participants |
Secondary
Plasma Concentration of Efgartigimod
Serum samples were collected at indicated time points to assess the pharmacokinetic (PK) profile of efgartigimod.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 4: Pre-dose | 38595 Nanograms per milliliter (ng/mL) | Standard Deviation 65900 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 4: 30 minutes post-dose | 206414 Nanograms per milliliter (ng/mL) | Standard Deviation 102089 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 8: Pre-dose | 14193 Nanograms per milliliter (ng/mL) | Standard Deviation 5753 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Day 1: Pre-dose | NA Nanograms per milliliter (ng/mL) | — |
| Efgartigimod | Plasma Concentration of Efgartigimod | Day 1: 30 minutes post-dose | 179391 Nanograms per milliliter (ng/mL) | Standard Deviation 79751 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 1: Pre-dose | 17238 Nanograms per milliliter (ng/mL) | Standard Deviation 37356 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 1: 30 minutes post-dose | 187300 Nanograms per milliliter (ng/mL) | Standard Deviation 73091 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 2: Pre-dose | 22470 Nanograms per milliliter (ng/mL) | Standard Deviation 42838 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 2: 30 minutes post-dose | 205148 Nanograms per milliliter (ng/mL) | Standard Deviation 52448 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 8: 30 minutes post-dose | 203505 Nanograms per milliliter (ng/mL) | Standard Deviation 89762 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 12: Pre-dose | 13096 Nanograms per milliliter (ng/mL) | Standard Deviation 4523 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 12: 30 minutes post-dose | 200856 Nanograms per milliliter (ng/mL) | Standard Deviation 138766 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 16: Pre-dose | 12676 Nanograms per milliliter (ng/mL) | Standard Deviation 5835 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 16: 30 minutes post-dose | 261647 Nanograms per milliliter (ng/mL) | Standard Deviation 215940 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 20: Pre-dose | 12942 Nanograms per milliliter (ng/mL) | Standard Deviation 4472 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 20: 30 minutes post-dose | 194944 Nanograms per milliliter (ng/mL) | Standard Deviation 81722 |
| Efgartigimod | Plasma Concentration of Efgartigimod | Week 24: 30 minutes post-dose | 14284 Nanograms per milliliter (ng/mL) | Standard Deviation 4987 |