Trial Outcomes & Findings for Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2) (NCT NCT05281523)

Last Updated: 2025-09-09

Results Overview

Total endoscopic nasal polyps (NP) score evaluated the size and extent of nasal polyps via endoscopy. The assessments were performed by central video image recordings of nasal endoscopy. The right and left nostrils were scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction of the inferior meatus). The scores were graded based on NP size, recorded as sum of the right and left nostril scores and ranges from 0 (no polyps) to 8 (large polyps), calculated by summing the scores \[0 to 4\] in each nostril; with higher scores indicating worse status. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

264 participants

Primary outcome timeframe

Baseline (Day 1) and at Week 52

Results posted on

2025-09-09

Participant Flow

A total of 264 participants were randomized to the study. Of which 257 participants were included in the Full Analysis Set (FAS) population. The FAS included all randomized participants who received at least 1 dose of study intervention excluding 7 participants from 2 sites with Good Clinical Practice (GCP)/data integrity issues.

A total of 264 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	Depemokimab Participants received a 100 milligram (mg) dose of depemokimab subcutaneous (SC) injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance Chronic rhinosinusitis with nasal polyps (CRSwNP) standard of care (SOC) treatment throughout the study.	Placebo Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Overall Study STARTED	132	132
Overall Study Full Analysis Population	129	128
Overall Study COMPLETED	122	111
Overall Study NOT COMPLETED	10	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Depemokimab Participants received a 100 milligram (mg) dose of depemokimab subcutaneous (SC) injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance Chronic rhinosinusitis with nasal polyps (CRSwNP) standard of care (SOC) treatment throughout the study.	Placebo Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Overall Study Adverse Event	1	1
Overall Study Physician Decision	1	1
Overall Study Withdrawal by Subject	5	15
Overall Study GCP violations	3	4

Baseline Characteristics

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Depemokimab n=129 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=128 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Total n=257 Participants Total of all reporting groups
Age, Continuous	50.5 YEARS STANDARD_DEVIATION 12.95 • n=5 Participants	50.4 YEARS STANDARD_DEVIATION 12.98 • n=7 Participants	50.4 YEARS STANDARD_DEVIATION 12.94 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	88 Participants n=7 Participants	177 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Race/Ethnicity, Customized WHITE	99 Participants n=5 Participants	98 Participants n=7 Participants	197 Participants n=5 Participants
Race/Ethnicity, Customized ALL OTHER RACES	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and at Week 52

Population: Full analysis set population included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites due to GCP violation. The overall number of participants analyzed represents only those participants available at the specified time points and evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Depemokimab n=129 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=128 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read)	-0.5 Scores on scale Standard Error 0.14	0.1 Scores on scale Standard Error 0.15

PRIMARY outcome

Timeframe: Baseline (Day 1) and from Week 49 to Week 52

Population: Full analysis set population included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. The overall number of participants analyzed represents only those participants available at the specified time points and evaluable for this outcome measure.

This endpoint evaluated the change from baseline in the mean nasal obstruction score using a Verbal Response Scale (VRS) from Week 49 through to Week 52. Participants used a VRS to rate nasal obstruction severity, with scores averaged over the specified period to assess treatment impact on nasal obstruction symptoms. Participants were asked to indicate the severity of nasal obstruction at their worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This was scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms), with higher scores indicating worse status. Baseline was defined as the average score from 28 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

Outcome measures

Outcome measures
Measure	Depemokimab n=129 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=128 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Change From Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale From Weeks 49 Through to Week 52	-0.77 Scores on scale Standard Error 0.076	-0.53 Scores on scale Standard Error 0.078

SECONDARY outcome

Timeframe: Baseline (Day 1) and from Week 49 to Week 52

Participants were asked to indicate the severity of rhinorrhea (runny nose) at their worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This was scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms). Higher scores indicated worst status. The average of daily scores in 4-weekly intervals were calculated and change from baseline data are presented for Weeks 49-52. Baseline was defined as the average score from 28 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

Outcome measures

Outcome measures
Measure	Depemokimab n=129 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=127 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Change From Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale From Week 49 Through to Week 52	-0.72 Scores on scale Standard Error 0.080	-0.54 Scores on scale Standard Error 0.082

SECONDARY outcome

Timeframe: Baseline (Day 1) and from Week 49 to Week 52

Participants were asked to indicate the severity of loss of smell at their worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This was scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms). Higher score indicates worse status. The average of daily scores in 4-weekly intervals were calculated and change from baseline data are presented for Weeks 49-52. Baseline was defined as the average score from 28 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

Outcome measures

Outcome measures
Measure	Depemokimab n=129 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=127 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Change From Baseline in Mean Symptom Score for Loss of Smell From Week 49 Through to Week 52	-0.56 Scores on scale Standard Error 0.066	-0.30 Scores on scale Standard Error 0.068

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 52

The LMK CT scoring system is based on CT imaging of the sinuses with points given for degree of opacification: 0 =normal, 1 = partial opacification, 2 = total opacification. These points were applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side (right and left). The osteomeatal complex (OC) is graded as 0 = not occluded, or 2 = occluded. The range for the total LMK CT score is therefore 0 (normal) to 24 (total opacification) when summed across both sides with higher scores indicating more severe disease. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.

Outcome measures

Outcome measures
Measure	Depemokimab n=121 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=111 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score at Week 52	-3.5 Scores on scale Standard Error 0.42	-0.3 Scores on scale Standard Error 0.44

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 52

Sino-nasal outcome test-22 is a 22-item measure of disease specific health related quality of life (HRQoL). Participants were asked to rate the severity of their condition on each of the 22 items over the previous 2 weeks using a 6-point rating scale of 0-5 including: 0 = Not present/no problem; 1 = Very mild problem; 2 = Mild or slight problem; 3 = Moderate problem; 4 = Severe problem; 5 = Problem as "bad as it can be". The scores for each question were summed up to derive the total score range for the SNOT-22 was from 0 (high quality of life) to 110 (worst quality of life), where higher scores indicate worse quality of life. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.

Outcome measures

Outcome measures
Measure	Depemokimab n=126 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=126 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52	-15.9 Scores on scale Standard Error 2.83	-6.0 Scores on scale Standard Error 2.87

SECONDARY outcome

Timeframe: Baseline (Day 1) and from Week 21 to Week 24

Participants were asked to indicate the severity of nasal obstruction at its worst over the previous 24 hours using a 4-point VRS. The response options were no symptoms, mild symptoms, moderate symptoms, and severe symptoms, scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms). Higher scores indicate more severe status. The average of daily scores in 4-weekly intervals were calculated and change from baseline data are presented for Weeks 21-24. Baseline was defined as the average score from 28 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

Outcome measures

Outcome measures
Measure	Depemokimab n=129 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=127 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Change From Baseline in Mean Nasal Obstruction Score From Week 21 Through to Week 24	-0.78 Scores on scale Standard Error 0.068	-0.54 Scores on scale Standard Error 0.069

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 26

Outcome measures

Outcome measures
Measure	Depemokimab n=128 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=127 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Change From Baseline in Total Endoscopic Nasal Polyps Score at Week 26	-0.5 Scores on scale Standard Error 0.12	-0.1 Scores on scale Standard Error 0.12

SECONDARY outcome

Timeframe: Up to Week 52

Population: For pooled studies of 217095 (NCT05274750) and 218079 (NCT05281523), the analysis was performed on the FAS population. The FAS included all randomized participants who received at least 1 dose of study treatment excluding participants from 1 site for 217095 and 2 sites for 218079 respectively with GCP violation. Participants were analyzed according to the treatment they were allocated at randomization.

Nasal polyp surgery is defined as any procedure involving instruments resulting in incision and removal of tissue from the nasal cavity (for example polypectomy). Time to first nasal polyp surgery (actual or entry on waiting list) or disease-modulating medication for CRSwNP up to Week 52 was assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523). The percentage of participants with nasal surgery or disease-modulating medication for CRSwNP and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Depemokimab n=272 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=256 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Percentage of Participants Requiring First Nasal Surgery (Actual or Entry on Waiting List) or Disease-Modulating Medication for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Up to Week 52	15.0 Percentage of participants Interval 11.3 to 19.9	21.9 Percentage of participants Interval 17.2 to 27.7

SECONDARY outcome

Timeframe: Up to Week 52

Population: For pooled studies of 217095 (NCT05274750) and 218079 (NCT05281523), the analysis was performed on the FAS population. The FAS included all randomized participants who took at least 1 dose of study treatment excluding participants from 1 site for 217095 and 2 sites for 218079 respectively with GCP violation. Participants were analyzed according to the treatment they were allocated at randomization.

Nasal polyp surgery is defined as any procedure involving instruments resulting in incision and removal of tissue from the nasal cavity (for example polypectomy).Time to first nasal polyp surgery (actual) or disease-modulating medication for CRSwNP up to week 52 was assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523). The percentage of participants with nasal surgery or disease-modulating medication for CRSwNP and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Depemokimab n=272 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=256 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Percentage of Participants Requiring First Nasal Surgery (Actual) or Disease-Modulating Medication for CRSwNP up to Week 52	12.2 Percentage of participants Interval 8.8 to 16.8	16.7 Percentage of participants Interval 12.6 to 22.0

SECONDARY outcome

Timeframe: Up to Week 52

Population: For pooled studies of 217095 (NCT05274750) and 218079 (NCT05281523), the analysis was performed on the FAS population. The FAS included all randomized participants who took at least 1 dose of study treatment excluding participants from 1 site for 217095 and 2 sites for 218079 respectively with GCP violation. Participants were analyzed according to the treatment they were allocated at randomization.

The percentage of participants requiring at least 1 course of systemic corticosteroids or disease-modulating medication for CRSwNP or nasal surgery (actual) during the Week 52 treatment period was assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523). Percentage of participants with nasal surgery or course of systemic CS for CRSwNP and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Depemokimab n=272 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=256 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Percentage of Participants Requiring at Least One Course of Systemic Corticosteroids or Disease-Modulating Medication for CRSwNP or Nasal Surgery (Actual) During the Week 52 Treatment Period	26 Percentage of participants	36 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 52

Population: For pooled studies of 217095 (NCT05274750) and 218079 (NCT05281523), the analysis was performed on the FAS population. The FAS included all randomized participants who took at least 1 dose of study drug excluding participants from 1 site for 217095 and 2 sites for 218079 respectively with GCP violation. Participants were analyzed according to the treatment they were allocated at randomization. The overall number of participants analyzed signifies participants evaluable for specified time points.

The ACQ-5 is a five-item questionnaire designed to be self-completed by the participants to assess the most common asthma symptoms. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheezing). The overall ACQ-5 response option is the mean score of all 5 questions representing 0 with no impairment/limitation and 6 as total impairment/ limitation. Higher scores indicated more limitations and lower scores with better asthma control. Impact on asthma control in the subgroup of participants with an ACQ-5 score greater than 0.75 (indicating partially or not well-controlled) at baseline was assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523). Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.

Outcome measures

Outcome measures
Measure	Depemokimab n=104 Participants Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=102 Participants Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52	-0.75 Scores on scale Standard Error 0.182	0.00 Scores on scale Standard Error 0.182

Adverse Events

Depemokimab

Serious events: 6 serious events

Other events: 75 other events

Deaths: 0 deaths

Placebo

Serious events: 10 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data do not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Depemokimab n=129 participants at risk Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Placebo n=128 participants at risk Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
Gastrointestinal disorders Diarrhoea	4.7% 6/129 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	1.6% 2/128 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Infections and infestations COVID-19	7.0% 9/129 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	8.6% 11/128 • Number of events 11 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Infections and infestations Influenza	2.3% 3/129 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	3.9% 5/128 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Infections and infestations Nasopharyngitis	21.7% 28/129 • Number of events 39 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	11.7% 15/128 • Number of events 22 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Infections and infestations Pharyngitis	3.1% 4/129 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	3.9% 5/128 • Number of events 5 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Infections and infestations Upper respiratory tract infection	10.9% 14/129 • Number of events 20 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	11.7% 15/128 • Number of events 22 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Musculoskeletal and connective tissue disorders Arthralgia	2.3% 3/129 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	4.7% 6/128 • Number of events 11 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Musculoskeletal and connective tissue disorders Back pain	2.3% 3/129 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	6.2% 8/128 • Number of events 9 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Nervous system disorders Headache	8.5% 11/129 • Number of events 15 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	10.2% 13/128 • Number of events 17 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Respiratory, thoracic and mediastinal disorders Asthma	1.6% 2/129 • Number of events 3 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	4.7% 6/128 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Respiratory, thoracic and mediastinal disorders Cough	3.9% 5/129 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	6.2% 8/128 • Number of events 10 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.7% 6/129 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	3.1% 4/128 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.9% 5/129 • Number of events 8 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	10.9% 14/128 • Number of events 16 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Respiratory, thoracic and mediastinal disorders Nasal polyps	5.4% 7/129 • Number of events 12 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	8.6% 11/128 • Number of events 15 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.1% 4/129 • Number of events 4 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	3.1% 4/128 • Number of events 7 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.
Vascular disorders Hypertension	1.6% 2/129 • Number of events 2 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.	3.9% 5/128 • Number of events 6 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) until follow up week 56. All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. AEs were reported treatment-wise.