Trial Outcomes & Findings for Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED) (NCT NCT04442269)

NCT ID: NCT04442269

Last Updated: 2025-04-04

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

At Week 24

Results posted on

2025-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Matching dupilumab without active substance	Dupilumab 300 mg Q2W Subcutaneous (SC) dose every two weeks (Q2W)
Overall Study STARTED	27	35
Overall Study COMPLETED	20	29
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Matching dupilumab without active substance	Dupilumab 300 mg Q2W Subcutaneous (SC) dose every two weeks (Q2W)
Overall Study Adverse Event	1	0
Overall Study Death	0	1
Overall Study Decision by the Investigator/Sponsor	1	1
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	3	2
Overall Study Protocol Deviation	0	1
Overall Study Travel Limitations	1	1

Baseline Characteristics

Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=27 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 Participants Subcutaneous (SC) dose every two weeks (Q2W)	Total n=62 Participants Total of all reporting groups
Age, Customized	57.1 years STANDARD_DEVIATION 14.38 • n=99 Participants	61.2 years STANDARD_DEVIATION 8.62 • n=107 Participants	59.4 years STANDARD_DEVIATION 11.56 • n=206 Participants
Sex: Female, Male Female	17 Participants n=99 Participants	22 Participants n=107 Participants	39 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	13 Participants n=107 Participants	23 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	4 Participants n=107 Participants	6 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=99 Participants	29 Participants n=107 Participants	53 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized White	25 Participants n=99 Participants	28 Participants n=107 Participants	53 Participants n=206 Participants
Race/Ethnicity, Customized Asian	1 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants
Race/Ethnicity, Customized Other	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants

PRIMARY outcome

Timeframe: At Week 24

Population: Randomized participants with available data for analysis in the statistical model

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=34 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo	0.002 Liters Standard Error 0.0558	0.203 Liters Standard Error 0.0482

SECONDARY outcome

Timeframe: Over the 24 to 52 Week Treatment Period

Population: The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized

Defined as severe respiratory exacerbations that are associated with a doubling of serum total Immunoglobulin E (IgE) from the prior pre-exacerbation value. Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Annualized Rate of ABPA-related Exacerbations Unadjusted Rate	0 Events per person-year Interval 0.0 to 0.0	0 Events per person-year Interval 0.0 to 0.0
Annualized Rate of ABPA-related Exacerbations Adjusted Rate	NA Events per person-year Negative Binomial Regression Model did not converge.	NA Events per person-year Negative Binomial Regression Model did not converge.

SECONDARY outcome

Timeframe: Over the 24 to 52 Week Treatment Period

Population: The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized

Defined as new onset of symptoms or clinical worsening of respiratory symptoms requiring systemic corticosteroid treatment for ≥3 consecutive days; for participants who are on maintenance systemic corticosteroids, at least double the dose of maintenance systemic corticosteroids for ≥3 consecutive days (with or without antibiotic therapy if indicated) Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Annualized Rate of Severe Respiratory Exacerbations Adjusted Rate	1.551 Events per person year	0.695 Events per person year
Annualized Rate of Severe Respiratory Exacerbations Unadjusted Rate	0.943 Events per person year	0.545 Events per person year

SECONDARY outcome

Timeframe: Over the 24 to 52 Week Treatment Period

Population: The full analysis set (FAS) includes all randomized participants. It is based on the treatment allocated as randomized

Annualized rate of severe respiratory exacerbations requiring either hospitalization or observation for \>24 hours in an emergency department/urgent care facility (events per person-year) Adjusted Rate: Negative Binomial Regression Model Unadjusted Rate: (Number of events)/(number of participant years)

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Annualized Rate of Severe Respiratory Exacerbations Requiring Either Hospitalization or Observation for >24 Hours in an ED/Urgent Care Facility Adjusted Rate	NA Events per person year Negative Binomial Regression Model did not converge.	NA Events per person year Negative Binomial Regression Model did not converge.
Annualized Rate of Severe Respiratory Exacerbations Requiring Either Hospitalization or Observation for >24 Hours in an ED/Urgent Care Facility Unadjusted Rate	0.041 Events per person year	0.128 Events per person year

SECONDARY outcome

Timeframe: Over the 24 to 52 Week Treatment Period

Population: Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest

ACQ is completed by patient to measure both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. The ACQ-5 score is the mean of the first 5 questions, between 0 (totally controlled) and 6 (severely uncontrolled). A higher score indicates lower asthma control. Participants with a score below 1.0 reflect adequately controlled asthma and participants with scores above 1.0 reflect inadequately controlled asthma. The optimal cut-point score of 1.50 should be used to be confident that a patient has inadequately controlled asthma.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score Week 36	-0.81 ACQ-5 Score Standard Deviation 0.878	-1.15 ACQ-5 Score Standard Deviation 1.208
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score Week 24	-1.10 ACQ-5 Score Standard Deviation 1.102	-1.24 ACQ-5 Score Standard Deviation 1.081
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score Week 44	-0.87 ACQ-5 Score Standard Deviation 1.233	-1.01 ACQ-5 Score Standard Deviation 1.359
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score Week 52	-0.84 ACQ-5 Score Standard Deviation 1.183	-1.29 ACQ-5 Score Standard Deviation 1.241

SECONDARY outcome

Timeframe: Over the 24 to 52 Week Treatment Period

Population: Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest

SGRQ will be completed by the patient to measure and quantify health status in adult participants with chronic airflow limitation. Total score ranges from 0 to 100. Scores by dimension are calculated for three domains: Symptoms, Activity, and Impacts (Psychosocial). Lower score indicates better Quality of Life (QoL).

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score Week 12	-9.463 SGRQ Total Score Standard Deviation 16.3993	-17.956 SGRQ Total Score Standard Deviation 14.6184
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score Week 24	-7.626 SGRQ Total Score Standard Deviation 14.5412	-23.079 SGRQ Total Score Standard Deviation 15.9104
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score Week 36	-8.796 SGRQ Total Score Standard Deviation 16.4257	-20.178 SGRQ Total Score Standard Deviation 15.5266
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score Week 52	-8.938 SGRQ Total Score Standard Deviation 15.3127	-25.309 SGRQ Total Score Standard Deviation 20.1035

SECONDARY outcome

Timeframe: Up to 52 Weeks

Population: Participants must have both the baseline and at least one post-baseline measurement at the given post-baseline time point to be included in the calculation of the proportion at the given post-baseline time point.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Percentage of Participants Achieving a Reduction in the SGRQ Total Score of 4 Points or Greater From Baseline Week 12	50.0 Percent Interval 30.72 to 69.28	85.3 Percent Interval 69.87 to 93.55
Percentage of Participants Achieving a Reduction in the SGRQ Total Score of 4 Points or Greater From Baseline Week 24	63.6 Percent Interval 42.95 to 80.27	87.1 Percent Interval 71.15 to 94.87
Percentage of Participants Achieving a Reduction in the SGRQ Total Score of 4 Points or Greater From Baseline Week 36	57.1 Percent Interval 36.55 to 75.53	86.2 Percent Interval 69.44 to 94.5
Percentage of Participants Achieving a Reduction in the SGRQ Total Score of 4 Points or Greater From Baseline Week 52	68.4 Percent Interval 46.01 to 84.64	89.3 Percent Interval 72.8 to 96.29

SECONDARY outcome

Timeframe: Over the 24 to 52 Week Treatment Period

Population: Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Percent Change From Baseline in Total IgE in Serum Week 24	-0.665 Percent Standard Deviation 40.2236	-47.245 Percent Standard Deviation 19.4110
Percent Change From Baseline in Total IgE in Serum Week 36	-5.945 Percent Standard Deviation 27.6767	-57.752 Percent Standard Deviation 18.0812
Percent Change From Baseline in Total IgE in Serum Week 52	-2.767 Percent Standard Deviation 42.8914	-62.175 Percent Standard Deviation 17.0285

SECONDARY outcome

Timeframe: Over the 24 to 52 Week Treatment Period

Population: Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Percent Change From Baseline in A Fumigatus-specific IgE in Serum Week 24	0.099 Percent Standard Deviation 39.7612	-39.859 Percent Standard Deviation 25.3095
Percent Change From Baseline in A Fumigatus-specific IgE in Serum Week 36	6.766 Percent Standard Deviation 39.9041	-45.654 Percent Standard Deviation 26.7915
Percent Change From Baseline in A Fumigatus-specific IgE in Serum Week 52	12.618 Percent Standard Deviation 94.6306	-49.126 Percent Standard Deviation 30.6790

SECONDARY outcome

Timeframe: Over the 24 to 52 Week Treatment Period

Population: Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Absolute Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Week 24	-4.80 ppb Standard Deviation 23.521	-22.04 ppb Standard Deviation 38.410
Absolute Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Week 36	3.11 ppb Standard Deviation 20.571	-21.48 ppb Standard Deviation 40.538
Absolute Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Week 44	1.38 ppb Standard Deviation 21.896	-19.18 ppb Standard Deviation 37.122
Absolute Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Week 52	-4.79 ppb Standard Deviation 27.634	-19.04 ppb Standard Deviation 35.471

SECONDARY outcome

Timeframe: Over the 24 to 52 Week Treatment Period

Population: Number of randomized patients with a baseline measurement and at least one post-baseline measurement at the post-baseline time point of interest

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Week 24	1.67 Percent Standard Deviation 44.069	-29.91 Percent Standard Deviation 32.527
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Week 36	19.80 Percent Standard Deviation 44.053	-24.56 Percent Standard Deviation 43.975
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Week 44	15.43 Percent Standard Deviation 54.887	-19.83 Percent Standard Deviation 48.308
Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Week 52	2.55 Percent Standard Deviation 56.506	-20.35 Percent Standard Deviation 48.100

SECONDARY outcome

Timeframe: Through the end of the 52 Week Treatment Period

Population: The safety analysis set (SAF) includes all randomized participants who received any study drug; it is based on the treatment received

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Baseline	22 Participants with TEAEs	30 Participants with TEAEs

SECONDARY outcome

Timeframe: Up to 64 Weeks

Population: The Pharmacokinetic Analysis Set (PKAS) includes all randomized participants who received any study drug and who had at least one non-missing drug concentration result following the first dose of study drug. The PKAS is based on the treatment received rather than as randomized.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=34 Participants Subcutaneous (SC) dose every two weeks (Q2W)
Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Responses and Titer Over Time TE & TB Maximum Titer Category Low (<1,000)	0 Participants	1 Participants
Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Responses and Titer Over Time TE & TB Maximum Titer Category Moderate (1,000 to 10,000)	0 Participants	0 Participants
Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Responses and Titer Over Time TE & TB Maximum Titer Category High (>10,000)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 64 Weeks

Population: Includes all randomized participants who received dupilumab and who had at least one non-missing dupilumab result following the first dose. The PKAS is based on the treatment received rather than as randomized.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Matching dupilumab without active substance	Dupilumab 300 mg Q2W Subcutaneous (SC) dose every two weeks (Q2W)
Concentrations of Functional Dupilumab in Serum by Treatment Regimen Week 52	82.2 mg/L Standard Deviation 55.4	—
Concentrations of Functional Dupilumab in Serum by Treatment Regimen Week 64	1.67 mg/L Standard Deviation 4.38	—
Concentrations of Functional Dupilumab in Serum by Treatment Regimen Week 0	0 mg/L Standard Deviation 0	—
Concentrations of Functional Dupilumab in Serum by Treatment Regimen Week 12	63.8 mg/L Standard Deviation 35.4	—
Concentrations of Functional Dupilumab in Serum by Treatment Regimen Week 24	86.5 mg/L Standard Deviation 53.6	—

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 19 other events

Deaths: 1 deaths

Dupilumab 300 mg Q2W

Serious events: 3 serious events

Other events: 29 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 844-734-6643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=27 participants at risk Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 participants at risk Subcutaneous (SC) dose every two weeks (Q2W)
Infections and infestations Influenza	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Pneumonia bacterial	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Appendicitis	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	2.9% 1/35 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Bronchopulmonary aspergillosis allergic	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	0.00% 0/35 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Lower respiratory tract infection	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	0.00% 0/35 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Pneumonia	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	0.00% 0/35 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	2.9% 1/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	2.9% 1/35 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	2.9% 1/35 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Renal and urinary disorders Nephrotic syndrome	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	2.9% 1/35 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Vascular disorders Deep vein thrombosis	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	2.9% 1/35 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Congenital, familial and genetic disorders Trisomy 16	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	0.00% 0/35 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Injury, poisoning and procedural complications Pelvic fracture	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	0.00% 0/35 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	0.00% 0/35 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	0.00% 0/35 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	0.00% 0/35 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)

Measure	Placebo n=27 participants at risk Matching dupilumab without active substance	Dupilumab 300 mg Q2W n=35 participants at risk Subcutaneous (SC) dose every two weeks (Q2W)
Infections and infestations COVID-19	11.1% 3/27 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	17.1% 6/35 • Number of events 6 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Upper respiratory tract infection	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	11.4% 4/35 • Number of events 6 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Urinary tract infection	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	11.4% 4/35 • Number of events 6 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Acute sinusitis	7.4% 2/27 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Bronchopulmonary aspergillosis allergic	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 5 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Conjunctivitis	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Cystitis	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Lower respiratory tract infection	7.4% 2/27 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Pneumonia	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Respiratory tract infection	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Rhinitis	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Sinusitis	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Tooth infection	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Viral upper respiratory tract infection	3.7% 1/27 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Infections and infestations Respiratory tract infection bacterial	11.1% 3/27 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	0.00% 0/35 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
General disorders Injection site erythema	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	11.4% 4/35 • Number of events 35 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
General disorders Injection site pain	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	8.6% 3/35 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
General disorders Injection site swelling	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	8.6% 3/35 • Number of events 6 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
General disorders Asthenia	11.1% 3/27 • Number of events 9 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
General disorders Influenza like illness	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
General disorders Malaise	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
General disorders Pyrexia	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Respiratory, thoracic and mediastinal disorders Asthma	11.1% 3/27 • Number of events 4 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	11.4% 4/35 • Number of events 5 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Respiratory, thoracic and mediastinal disorders Cough	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	11.4% 4/35 • Number of events 6 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Respiratory, thoracic and mediastinal disorders Respiratory disorder	33.3% 9/27 • Number of events 22 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	11.4% 4/35 • Number of events 4 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	22.9% 8/35 • Number of events 15 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	8.6% 3/35 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	8.6% 3/35 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Nervous system disorders Headache	7.4% 2/27 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	17.1% 6/35 • Number of events 15 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Gastrointestinal disorders Nausea	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	8.6% 3/35 • Number of events 3 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Gastrointestinal disorders Constipation	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Gastrointestinal disorders Gastrooesophageal reflux disease	3.7% 1/27 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Gastrointestinal disorders Abdominal pain upper	7.4% 2/27 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	2.9% 1/35 • Number of events 1 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)
Eye disorders Blepharitis	0.00% 0/27 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)	5.7% 2/35 • Number of events 2 • From Day 1 to EOS (End Of Study) visit ~(up to 64 weeks)