Trial Outcomes & Findings for A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS) (NCT NCT05817669)

Last Updated: 2025-07-18

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Week 24

Results posted on

2025-07-18

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Efgartigimod Participants received efgartigimod 10 milligram per kilogram (mg/kg) once weekly via intravenous (IV) infusion for up to 24 weeks.	Placebo Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Overall Study STARTED	23	11
Overall Study COMPLETED	20	7
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Efgartigimod Participants received efgartigimod 10 milligram per kilogram (mg/kg) once weekly via intravenous (IV) infusion for up to 24 weeks.	Placebo Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Overall Study Prohibited medication used	1	2
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Efgartigimod n=23 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=11 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.	Total n=34 Participants Total of all reporting groups
Age, Continuous	50.1 Years STANDARD_DEVIATION 12.57 • n=5 Participants	54.7 Years STANDARD_DEVIATION 12.42 • n=7 Participants	51.6 Years STANDARD_DEVIATION 12.52 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	11 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	11 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	22 Participants n=5 Participants	11 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The Efficacy Analysis Set (EAS) included all participants eligible for efficacy evaluation.

Outcome measures

Outcome measures
Measure	Efgartigimod n=22 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=9 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24	45.5 Percentage of participants Interval 26.92 to 65.34	11.1 Percentage of participants Interval 1.99 to 43.5

SECONDARY outcome

Timeframe: Up to 32 weeks

Population: The Safety Analysis Set (SAF) included all participants exposed to the study treatment.

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'.

Outcome measures

Outcome measures
Measure	Efgartigimod n=23 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=11 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Number of Participants With TEAEs, AESI, and SAEs Any TEAE	20 Participants	7 Participants
Number of Participants With TEAEs, AESI, and SAEs Any AESI	15 Participants	5 Participants
Number of Participants With TEAEs, AESI, and SAEs Any SAE	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24

Population: EAS.

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.

Outcome measures

Outcome measures
Measure	Efgartigimod n=22 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=9 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Percentage of Participants With MCII in ESSDAI at Week 24	72.7 Percentage of participants Interval 51.85 to 86.85	55.6 Percentage of participants Interval 26.67 to 81.12

SECONDARY outcome

Timeframe: Week 24

Population: EAS.

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.

Outcome measures

Outcome measures
Measure	Efgartigimod n=22 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=9 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Percentage of Participants With Low Disease Activity in ESSDAI at Week 24	59.1 Percentage of participants Interval 38.73 to 76.74	22.2 Percentage of participants Interval 6.32 to 54.74

SECONDARY outcome

Timeframe: Week 24

Population: EAS.

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.

Outcome measures

Outcome measures
Measure	Efgartigimod n=22 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=9 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Percentage of Participants With MCII in clinESSDAI at Week 24	77.3 Percentage of participants Interval 56.56 to 89.88	77.8 Percentage of participants Interval 45.26 to 93.68

SECONDARY outcome

Timeframe: Week 24

Population: EAS.

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.

Outcome measures

Outcome measures
Measure	Efgartigimod n=22 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=9 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Percentage of Participants With Low Disease Activity in clinESSDAI at Week 24	59.1 Percentage of participants Interval 38.73 to 76.74	33.3 Percentage of participants Interval 12.06 to 64.58

SECONDARY outcome

Timeframe: Week 24

Population: EAS.

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).

Outcome measures

Outcome measures
Measure	Efgartigimod n=22 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=9 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Percentage of Participants With MCII in ESSPRI at Week 24	31.8 Percentage of participants Interval 16.36 to 52.68	33.3 Percentage of participants Interval 12.06 to 64.58

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: EAS - Only participants with data collected at baseline and Week 24 are reported.

Outcome measures

Outcome measures
Measure	Efgartigimod n=19 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=7 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Change From Baseline in ESSDAI Score at Week 24	-5.0 score on a scale Interval -10.0 to -4.0	-4.0 score on a scale Interval -13.0 to -1.0

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: EAS - Only participants with data collected at baseline and Week 24 are reported.

Outcome measures

Outcome measures
Measure	Efgartigimod n=19 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=7 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Change From Baseline in clinESSDAI Score at Week 24	-7.0 score on a scale Interval -12.0 to -3.0	-4.0 score on a scale Interval -17.0 to -3.0

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: EAS - Only participants with data collected at Baseline and Week 24 are reported.

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).

Outcome measures

Outcome measures
Measure	Efgartigimod n=16 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=6 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Change From Baseline in ESSPRI Score at Week 24	-0.500 score on a scale Interval -1.333 to 0.333	-0.833 score on a scale Interval -1.333 to -0.333

SECONDARY outcome

Timeframe: Week 24

Population: EAS.

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).

Outcome measures

Outcome measures
Measure	Efgartigimod n=22 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=9 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Percentage of Participants With STAR Score of at Least 5 at Week 24	54.5 Percentage of participants Interval 34.66 to 73.08	33.3 Percentage of participants Interval 12.06 to 64.58

SECONDARY outcome

Timeframe: 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.

Serum samples were collected at indicated time points to assess the pharmacokinetic (PK) profile of efgartigimod.

Outcome measures

Outcome measures
Measure	Efgartigimod n=23 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Plasma Concentration of Efgartigimod Week 4: 30 minutes post-dose	206414 Nanograms per milliliter (ng/mL) Standard Deviation 102089	—
Plasma Concentration of Efgartigimod Day 1: Pre-dose	NA Nanograms per milliliter (ng/mL) Standard Deviation NA Mean and standard deviation could not be calculated as the values were below the lower limit of quantification (LLOQ). LLOQ was 200 ng/mL.	—
Plasma Concentration of Efgartigimod Day 1: 30 minutes post-dose	179391 Nanograms per milliliter (ng/mL) Standard Deviation 79751	—
Plasma Concentration of Efgartigimod Week 1: Pre-dose	17238 Nanograms per milliliter (ng/mL) Standard Deviation 37356	—
Plasma Concentration of Efgartigimod Week 1: 30 minutes post-dose	187300 Nanograms per milliliter (ng/mL) Standard Deviation 73091	—
Plasma Concentration of Efgartigimod Week 2: Pre-dose	22470 Nanograms per milliliter (ng/mL) Standard Deviation 42838	—
Plasma Concentration of Efgartigimod Week 2: 30 minutes post-dose	205148 Nanograms per milliliter (ng/mL) Standard Deviation 52448	—
Plasma Concentration of Efgartigimod Week 4: Pre-dose	38595 Nanograms per milliliter (ng/mL) Standard Deviation 65900	—
Plasma Concentration of Efgartigimod Week 8: Pre-dose	14193 Nanograms per milliliter (ng/mL) Standard Deviation 5753	—
Plasma Concentration of Efgartigimod Week 8: 30 minutes post-dose	203505 Nanograms per milliliter (ng/mL) Standard Deviation 89762	—
Plasma Concentration of Efgartigimod Week 12: Pre-dose	13096 Nanograms per milliliter (ng/mL) Standard Deviation 4523	—
Plasma Concentration of Efgartigimod Week 12: 30 minutes post-dose	200856 Nanograms per milliliter (ng/mL) Standard Deviation 138766	—
Plasma Concentration of Efgartigimod Week 16: Pre-dose	12676 Nanograms per milliliter (ng/mL) Standard Deviation 5835	—
Plasma Concentration of Efgartigimod Week 16: 30 minutes post-dose	261647 Nanograms per milliliter (ng/mL) Standard Deviation 215940	—
Plasma Concentration of Efgartigimod Week 20: Pre-dose	12942 Nanograms per milliliter (ng/mL) Standard Deviation 4472	—
Plasma Concentration of Efgartigimod Week 20: 30 minutes post-dose	194944 Nanograms per milliliter (ng/mL) Standard Deviation 81722	—
Plasma Concentration of Efgartigimod Week 24: 30 minutes post-dose	14284 Nanograms per milliliter (ng/mL) Standard Deviation 4987	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: SAF - Only participants with data available at baseline and Week 24 are reported.

Blood samples were collected at indicated timepoints to assess the total Immunoglobulin (Ig)G levels in serum.

Outcome measures

Outcome measures
Measure	Efgartigimod n=20 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=7 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Percentage Change From Baseline in Total IgG Levels in Serum at Week 24	-57.172 Percentage change Standard Deviation 17.7376	0.279 Percentage change Standard Deviation 9.5193

SECONDARY outcome

Timeframe: Up to Week 24

Population: SAF.

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.

Outcome measures

Outcome measures
Measure	Efgartigimod n=23 Participants Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=11 Participants Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Number of Participants With ADA Against Efgartigimod in Serum Treatment-boosted ADA	1 Participants	0 Participants
Number of Participants With ADA Against Efgartigimod in Serum Treatment-induced ADA	2 Participants	0 Participants
Number of Participants With ADA Against Efgartigimod in Serum Treatment-unaffected ADA	11 Participants	3 Participants

Adverse Events

Efgartigimod

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Efgartigimod n=23 participants at risk Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=11 participants at risk Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Vascular disorders Vasospasm	4.3% 1/23 • Number of events 1 • 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.	0.00% 0/11 • 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.

Other adverse events

Additional Information

Regulatory manager

Argenx

Phone: Please email:

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Efgartigimod n=23 participants at risk Participants received efgartigimod 10 mg/kg once weekly via IV infusion for up to 24 weeks.	Placebo n=11 participants at risk Participants received placebo matched to efgartigimod once weekly via IV infusion for up to 24 weeks.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Cardiac disorders Palpitations	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Ear and labyrinth disorders Motion sickness	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Gastrointestinal disorders Diarrhoea	8.7% 2/23 • Number of events 2 • 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.	0.00% 0/11 • 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.
Gastrointestinal disorders Peptic ulcer	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Gastrointestinal disorders Vomiting	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
General disorders Fatigue	8.7% 2/23 • Number of events 2 • 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.	0.00% 0/11 • 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.
General disorders Malaise	8.7% 2/23 • Number of events 3 • 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.	0.00% 0/11 • 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.
Infections and infestations Conjunctivitis	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Infections and infestations COVID-19	8.7% 2/23 • Number of events 2 • 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.	0.00% 0/11 • 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.
Infections and infestations Cystitis	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Infections and infestations Gastroenteritis	8.7% 2/23 • Number of events 2 • 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.	0.00% 0/11 • 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.
Infections and infestations Gastrointestinal infection	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Infections and infestations Influenza	13.0% 3/23 • Number of events 3 • 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.	0.00% 0/11 • 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.
Infections and infestations Nasopharyngitis	17.4% 4/23 • Number of events 5 • 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.	9.1% 1/11 • Number of events 1 • 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.
Infections and infestations Upper respiratory tract infection	13.0% 3/23 • Number of events 3 • 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.	18.2% 2/11 • Number of events 2 • 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.
Infections and infestations Urinary tract infection	13.0% 3/23 • Number of events 3 • 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.	9.1% 1/11 • Number of events 1 • 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.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Nervous system disorders Dizziness	8.7% 2/23 • Number of events 3 • 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.	0.00% 0/11 • 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.
Nervous system disorders Headache	17.4% 4/23 • Number of events 6 • 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.	9.1% 1/11 • Number of events 1 • 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.
Nervous system disorders Syncope	4.3% 1/23 • Number of events 1 • 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.	9.1% 1/11 • Number of events 1 • 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.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Cough	8.7% 2/23 • Number of events 3 • 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.	0.00% 0/11 • 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.7% 2/23 • Number of events 2 • 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.	9.1% 1/11 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/23 • 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.	9.1% 1/11 • Number of events 1 • 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.