Trial Outcomes & Findings for Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma (NCT NCT05062759)

NCT ID: NCT05062759

Last Updated: 2023-06-22

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

70 participants

Primary outcome timeframe

From Week 12 to Week 16

Results posted on

2023-06-22

Participant Flow

This study was conducted in 15 study centres in the United States between 23 August 2021 and 18 July 2022.

The Screening period was 2 to 3 weeks before randomisation. Patients were randomised in a 1:1 ratio to receive tezepelumab or placebo. All the study assessments were performed as per the Schedule of Activities.

Participant milestones

Participant milestones
Measure	Tezepelumab Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Overall Study STARTED	35	35
Overall Study COMPLETED	34	34
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Tezepelumab Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Overall Study Death	0	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tezepelumab n=35 Participants Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo n=35 Participants Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS	Total n=70 Participants Total of all reporting groups
Age, Continuous	16.3 years STANDARD_DEVIATION 2.3 • n=5 Participants	16.6 years STANDARD_DEVIATION 3.1 • n=7 Participants	16.5 years STANDARD_DEVIATION 3.0 • n=5 Participants
Age, Customized In utero	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Preterm newborn infants (gestational age < 37 wks)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Infants and toddlers (28 days-23 months)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adolescents (12-17 years)	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Age, Customized Adults (18-64 years)	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Customized From 65-84 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Week 12 to Week 16

Population: Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or Microneutralization antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.

Outcome measures

Outcome measures
Measure	Tezepelumab n=33 Participants Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo n=33 Participants Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs) Influenza A H1N1	7.34 Fold change Geometric Coefficient of Variation 1.361 • Interval 1.361 to	4.75 Fold change Geometric Coefficient of Variation 1.455 • Interval 1.455 to
Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs) Influenza B Yamagata Lineage	1.76 Fold change Geometric Coefficient of Variation 0.955 • Interval 0.955 to	1.46 Fold change Geometric Coefficient of Variation 0.937 • Interval 0.937 to
Post-vaccination Strain-specific Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rises (GMFRs) Influenza B Victoria Lineage	2.94 Fold change Geometric Coefficient of Variation 1.054 • Interval 1.054 to	2.90 Fold change Geometric Coefficient of Variation 0.841 • Interval 0.841 to

PRIMARY outcome

Timeframe: From Week 12 to Week 16

Population: Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.

Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.

Outcome measures

Outcome measures
Measure	Tezepelumab n=33 Participants Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo n=33 Participants Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs Influenza A H1N1	14.56 Fold change Geometric Coefficient of Variation 2.581 • Interval 2.581 to	10.62 Fold change Geometric Coefficient of Variation 2.409 • Interval 2.409 to
Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs Influenza A H3N2	4.73 Fold change Geometric Coefficient of Variation 1.509 • Interval 1.509 to	5.90 Fold change Geometric Coefficient of Variation 3.180 • Interval 3.18 to
Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs Influenza B Yamagata Lineage	4.00 Fold change Geometric Coefficient of Variation 1.541 • Interval 1.541 to	3.56 Fold change Geometric Coefficient of Variation 2.206 • Interval 2.206 to
Post-vaccination Strain-specific Microneutralization (MN) Antibody GMFRs Influenza B Victoria Lineage	4.08 Fold change Geometric Coefficient of Variation 2.279 • Interval 2.279 to	5.04 Fold change Geometric Coefficient of Variation 1.723 • Interval 1.723 to

PRIMARY outcome

Timeframe: Week 16

Population: Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.

Outcome measures

Outcome measures
Measure	Tezepelumab n=33 Participants Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo n=33 Participants Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs) Influenza A H1N1	809.23 Titer Geometric Coefficient of Variation 0.921 • Interval 0.921 to	596.76 Titer Geometric Coefficient of Variation 1.076 • Interval 1.076 to
Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs) Influenza B Yamagata Lineage	167.46 Titer Geometric Coefficient of Variation 0.925 • Interval 0.925 to	161.56 Titer Geometric Coefficient of Variation 0.688 • Interval 0.688 to
Post-vaccination Strain-specific Serum HAI Antibody Geometric Mean Titers (GMTs) Influenza B Victoria Lineage	194.68 Titer Geometric Coefficient of Variation 1.089 • Interval 1.089 to	200.55 Titer Geometric Coefficient of Variation 0.948 • Interval 0.948 to

PRIMARY outcome

Timeframe: Week 16

Population: Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.

Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.

Outcome measures

Outcome measures
Measure	Tezepelumab n=33 Participants Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo n=33 Participants Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Post-vaccination Strain-specific Serum MN Antibody GMTs Influenza A H1N1	382.55 Titer Geometric Coefficient of Variation 1.469 • Interval 1.469 to	303.63 Titer Geometric Coefficient of Variation 1.667 • Interval 1.667 to
Post-vaccination Strain-specific Serum MN Antibody GMTs Influenza A H3N2	600.92 Titer Geometric Coefficient of Variation 2.154 • Interval 2.154 to	457.33 Titer Geometric Coefficient of Variation 2.336 • Interval 2.336 to
Post-vaccination Strain-specific Serum MN Antibody GMTs Influenza B Yamagata Lineage	355.44 Titer Geometric Coefficient of Variation 1.076 • Interval 1.076 to	366.81 Titer Geometric Coefficient of Variation 1.270 • Interval 1.27 to
Post-vaccination Strain-specific Serum MN Antibody GMTs Influenza B Victoria Lineage	125.67 Titer Geometric Coefficient of Variation 4.687 • Interval 4.687 to	124.35 Titer Geometric Coefficient of Variation 3.515 • Interval 3.515 to

PRIMARY outcome

Timeframe: Week 16

Population: Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.

Outcome measures

Outcome measures
Measure	Tezepelumab n=33 Participants Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo n=33 Participants Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in HAI Antibody Titer Influenza A H1N1	78.8 Percentage of participants 90% Confidence Interval 63.82 • Interval 63.82 to 89.6	51.5 Percentage of participants 90% Confidence Interval 36.07 • Interval 36.07 to 66.74
Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in HAI Antibody Titer Influenza B Yamagata Lineage	15.2 Percentage of participants 90% Confidence Interval 6.17 • Interval 6.17 to 29.25	15.2 Percentage of participants 90% Confidence Interval 6.17 • Interval 6.17 to 29.25
Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in HAI Antibody Titer Influenza B Victoria Lineage	30.3 Percentage of participants 90% Confidence Interval 17.46 • Interval 17.46 to 45.96	39.4 Percentage of participants 90% Confidence Interval 25.11 • Interval 25.11 to 55.18

PRIMARY outcome

Timeframe: Week 16

Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.

Outcome measures

Outcome measures
Measure	Tezepelumab n=33 Participants Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo n=33 Participants Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in MN Antibody Titer Influenza A H1N1	81.8 Percentage of participants 90% Confidence Interval 67.24 • Interval 67.24 to 91.77	75.8 Percentage of participants 90% Confidence Interval 60.49 • Interval 60.49 to 87.32
Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in MN Antibody Titer Influenza A H3N2	60.6 Percentage of participants 90% Confidence Interval 44.82 • Interval 44.82 to 74.89	51.5 Percentage of participants 90% Confidence Interval 36.07 • Interval 36.07 to 66.74
Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in MN Antibody Titer Influenza B Yamagata Lineage	51.5 Percentage of participants 90% Confidence Interval 36.07 • Interval 36.07 to 66.74	36.4 Percentage of participants 90% Confidence Interval 22.50 • Interval 22.5 to 52.16
Percentage of Patients With Post-vaccination Strain-specific Antibody Response at Week 16 With Antibody Response Defined as a ≥ 4-fold Rise in MN Antibody Titer Influenza B Victoria Lineage	54.5 Percentage of participants 90% Confidence Interval 38.94 • Interval 38.94 to 69.51	63.6 Percentage of participants 90% Confidence Interval 47.84 • Interval 47.84 to 77.5

PRIMARY outcome

Timeframe: Week 16

Population: Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.

Outcome measures

Outcome measures
Measure	Tezepelumab n=33 Participants Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo n=33 Participants Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer ≥ 40 Influenza A H1N1	100 Percentage of participants 90% Confidence Interval 91.32 • Interval 91.32 to 100.0	100 Percentage of participants 90% Confidence Interval 91.32 • Interval 91.32 to 100.0
Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer ≥ 40 Influenza B Yamagata Lineage	97 Percentage of participants 90% Confidence Interval 86.41 • Interval 86.41 to 99.84	100 Percentage of participants 90% Confidence Interval 91.32 • Interval 91.32 to 100.0
Percentage of Patients With Post-vaccination Strain-specific HAI Antibody Titer ≥ 40 Influenza B Victoria Lineage	100 Percentage of participants 90% Confidence Interval 91.32 • Interval 91.32 to 100.0	97.0 Percentage of participants 90% Confidence Interval 86.41 • Interval 86.41 to 99.84

PRIMARY outcome

Timeframe: Week 16

Population: Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.

Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed.

Outcome measures

Outcome measures
Measure	Tezepelumab n=33 Participants Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo n=33 Participants Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40 Influenza A H1N1	100 Percentage of participants 90% Confidence Interval 91.32 • Interval 91.32 to 100.0	93.9 Percentage of participants 90% Confidence Interval 82.13 • Interval 82.13 to 98.91
Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40 Influenza B Yamagata Lineage	97 Percentage of participants 90% Confidence Interval 86.41 • Interval 86.41 to 99.84	100 Percentage of participants 90% Confidence Interval 91.32 • Interval 91.32 to 100.0
Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40 Influenza A H3N2	93.9 Percentage of participants 90% Confidence Interval 82.13 • Interval 82.13 to 98.91	97 Percentage of participants 90% Confidence Interval 86.41 • Interval 86.41 to 99.84
Percentage of Patients With Post-vaccination Strain-specific MN Antibody Titer ≥ 40 Influenza B Victoria Lineage	78.8 Percentage of participants 90% Confidence Interval 63.82 • Interval 63.82 to 89.6	81.8 Percentage of participants 90% Confidence Interval 67.24 • Interval 67.24 to 91.77

SECONDARY outcome

Timeframe: Week 0, Week 12, Week 16 and Week 28

Population: Pharmacokinetic (PK) analysis set consisted of all patients who received tezepelumab and from whom PK blood samples were obtained and assumed not to be affected by factors such as protocol deviations. Here, Number of patients analyzed in each row reflects number of patients analyzed for that timepoint

Tezepelumab serum concentrations were summarized using descriptive statistics at each visit.

Outcome measures

Outcome measures
Measure	Tezepelumab n=32 Participants Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Serum Tezepelumab Concentrations Week 12	27.00 microgram/milliliter (μg/mL) Geometric Coefficient of Variation 0.5421	—
Serum Tezepelumab Concentrations Week 28	2.79 microgram/milliliter (μg/mL) Geometric Coefficient of Variation 1.0705	—
Serum Tezepelumab Concentrations Week 0	NA microgram/milliliter (μg/mL) Geometric Coefficient of Variation NA Not calculable as 31 of 32 participants had concentrations below lower limit of quantification (0.010 ug/ml). The remaining participant had serum concentration of 0.0235 ug/ml.	—
Serum Tezepelumab Concentrations Week 16	20.76 microgram/milliliter (μg/mL) Geometric Coefficient of Variation 3.6969	—

SECONDARY outcome

Timeframe: From Baseline to Week 28

Population: Safety analysis set consisted of all patients who received at least 1 dose of study intervention.

Immunogenicity assessments were performed. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with ≥16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA.

Outcome measures

Outcome measures
Measure	Tezepelumab n=35 Participants Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo n=35 Participants Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Immunogenicity ADA prevalence	0 Patients	4 Patients
Immunogenicity Only baseline ADA positive	0 Patients	0 Patients
Immunogenicity Any baseline ADA positive	0 Patients	0 Patients
Immunogenicity Both baseline and post-baseline ADA positive	0 Patients	0 Patients
Immunogenicity Any post-baseline ADA positive	0 Patients	4 Patients
Immunogenicity Treatment-induced ADA positive	0 Patients	4 Patients
Immunogenicity ADA persistently positive	0 Patients	4 Patients
Immunogenicity ADA transiently positive	0 Patients	0 Patients
Immunogenicity Treatment-boosted ADA positive	0 Patients	0 Patients
Immunogenicity TE-ADA positive (ADA incidence)	0 Patients	4 Patients

Adverse Events

Tezepelumab

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Tezepelumab n=35 participants at risk Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo n=35 participants at risk Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Injury, poisoning and procedural complications Stab wound	0.00% 0/35 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)	2.9% 1/35 • Number of events 1 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)

Other adverse events

Other adverse events
Measure	Tezepelumab n=35 participants at risk Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS	Placebo n=35 participants at risk Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS
Infections and infestations COVID-19	22.9% 8/35 • Number of events 8 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)	22.9% 8/35 • Number of events 8 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)
Infections and infestations Acute sinusitis	8.6% 3/35 • Number of events 3 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)	0.00% 0/35 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)
Infections and infestations Ear infection	2.9% 1/35 • Number of events 1 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)	5.7% 2/35 • Number of events 2 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)
Infections and infestations Viral upper respiratory tract infection	2.9% 1/35 • Number of events 1 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)	5.7% 2/35 • Number of events 2 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)
Infections and infestations Pharyngitis	0.00% 0/35 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)	5.7% 2/35 • Number of events 2 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)
Infections and infestations Sinusitis	0.00% 0/35 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)	5.7% 2/35 • Number of events 2 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 1/35 • Number of events 2 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)	5.7% 2/35 • Number of events 2 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)
Injury, poisoning and procedural complications Skin laceration	5.7% 2/35 • Number of events 2 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)	0.00% 0/35 • From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)

Additional Information

Global Clinical Head

AstraZeneca Clinical Study Information Center

Phone: +187724094 79

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
Publication restrictions are in place

Restriction type: OTHER