Trial Outcomes & Findings for Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID) (NCT NCT04157335)

Last Updated: 2026-02-19

Results Overview

The total nasal polyp score (NPS) is the sum of the right and left nostril scores (maximum of 8), as evaluated by nasal endoscopy. Higher scores indicate greater symptom severity. The left and right score will be based on a central read with a scale from 0 to 4. Each nasal endoscopy is evaluated by two independent physician reviewers.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

295 participants

Primary outcome timeframe

Baseline to Week 56

Results posted on

2026-02-19

Participant Flow

A total of 723 participants were screened between 15NOV2019 and 01JUN2023. Of those, 295 were randomized to either the treatment (147 participants) or placebo (148 participants) arms of the double-blind treatment period. Eight participants were excluded due to Japan GCP breach. Therefore, 144 participants started in the treatment arm and 143 in the placebo arm, for a total of 287 participants.

All patients completed a 6-week run-in period during which inclusion/exclusion criteria was assessed, medical history and surgical history were documented, Nasal endoscopy performed, and patient reported outcomes (PROs), clinical laboratories, and diet questionnaires were administered.

Participant milestones

Participant milestones
Measure	Double Blind Benralizumab 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Placebo 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Double-Blind Period STARTED	144	143
Double-Blind Period COMPLETED	129	130
Double-Blind Period NOT COMPLETED	15	13
Open-Label Extension Period STARTED	122	125
Open-Label Extension Period COMPLETED	80	86
Open-Label Extension Period NOT COMPLETED	42	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Double Blind Benralizumab 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Placebo 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Double-Blind Period IP discontinuation	1	1
Double-Blind Period Withdrawal by Subject	9	6
Double-Blind Period Pregnancy	1	0
Double-Blind Period Physician Decision	1	2
Double-Blind Period Lost to Follow-up	0	2
Double-Blind Period Adverse Event	1	1
Double-Blind Period Site closure	2	0
Double-Blind Period Patient did not meet randomization criteria	0	1
Open-Label Extension Period Study terminated by sponsor	19	26
Open-Label Extension Period Withdrawal by Subject	18	6
Open-Label Extension Period Physician Decision	3	2
Open-Label Extension Period Adverse Event	1	3
Open-Label Extension Period patient withdrew due to failure of treatment	1	2

Baseline Characteristics

Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=287 Participants Total of all reporting groups	Double Blind Benralizumab n=144 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Placebo n=143 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants
Age, Categorical Between 18 and 65 years	254 Participants n=4 Participants	128 Participants n=4 Participants	126 Participants
Age, Categorical >=65 years	33 Participants n=4 Participants	16 Participants n=4 Participants	17 Participants
Age, Continuous	49.6 Years STANDARD_DEVIATION 12.7 • n=4 Participants	49.5 Years STANDARD_DEVIATION 12.7 • n=4 Participants	49.8 Years STANDARD_DEVIATION 12.7
Sex: Female, Male Female	115 Participants n=4 Participants	61 Participants n=4 Participants	54 Participants
Sex: Female, Male Male	172 Participants n=4 Participants	83 Participants n=4 Participants	89 Participants
Race/Ethnicity, Customized White	150 Participants n=4 Participants	77 Participants n=4 Participants	73 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=4 Participants	0 Participants n=4 Participants	2 Participants
Race/Ethnicity, Customized Asian	132 Participants n=4 Participants	66 Participants n=4 Participants	66 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants
Race/Ethnicity, Customized Other	3 Participants n=4 Participants	1 Participants n=4 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline to Week 56

Population: Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo). The analysis included all participants with baseline and at least one evaluable post-baseline assessment and all the participants with a baseline assessment who are rescued by surgery and/or SCS use for CRSwNP.

Outcome measures

Outcome measures
Measure	Double Blind Placebo n=121 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab n=127 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Change From Baseline in Endoscopic Total Nasal Polyp Score (NPS) at Week 56	-0.1 Score Standard Deviation 1.3	-0.3 Score Standard Deviation 1.6

PRIMARY outcome

Timeframe: Baseline to week 56

The NBS is an item in the NPSD. Patients were asked to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 - none; 1 - mild; 2 - moderate; 3 - severe. Higher scores indicate greater symptom severity. The NBS and the changes from baseline were summarised every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Bi-weekly mean were calculated if at least 8 days in each 14-day period had evaluable data; otherwise, the biweekly mean was set to missing.

Outcome measures

Outcome measures
Measure	Double Blind Placebo n=118 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab n=114 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Change From Baseline in Mean Nasal Blockage Score (NBS) at Week 56.	-0.45 Score Standard Deviation 0.90	-0.64 Score Standard Deviation 0.98

SECONDARY outcome

Timeframe: Baseline to Week 56

The DSS is an item in the NPSD. Patients were asked to rate the severity of their worst difficulty with sense of smell over the past 24 hours using the following response options: 0-none; 1-mild; 2-moderate; 3-severe. Higher scores indicate greater symptom severity. The DSS and the changes from baseline were summarised every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Bi-weekly mean of DSS was calculated if at least 8 days in each 14-day period have evaluable data; otherwise the bi-weekly mean was set to missing.

Outcome measures

Outcome measures
Measure	Double Blind Placebo n=118 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab n=114 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Change From Baseline in Difficulty With Sense of Smell (DSS) Score at Week 56.	-0.05 Score Standard Deviation 0.56	-0.26 Score Standard Deviation 0.78

SECONDARY outcome

Timeframe: Baseline to Week 56

Change from baseline in Lund- Mackay score (LMS). The Lund-Mackay score scoring system is used to provide a quantitative assessment of nasal sinuses on sinus CT scans. Based on the sinus CT images, the five sinuses (maxillary, anterior ethmoid, posterior ethmoid, sphenoid and frontal) on each site are score by central radiologist as follows: (0-Normal; 1-Partial Opacification; 2-Total Opacification). The osteomeatal complex is scored for right and left sides (0 - Not occluded; 2- Occluded). The total score ranges from 0 to 24 (higher scores indicate poorer outcomes).

Outcome measures

Outcome measures
Measure	Double Blind Placebo n=104 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab n=114 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Sinus Opacification by CT Scan at Week 56.	-0.7 Score Standard Deviation 3.5	-1.3 Score Standard Deviation 3.4

SECONDARY outcome

Timeframe: Baseline to Week 56

SinoNasal Outcome Test 22 scores are participant-reported and assess physical problems, functional limitations and emotional consequences of SinoNasal conditions. Patient-reported symptom severity and symptom impact over the past 2 weeks are captured via a 6-point scale (0-No Problem to 5-Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110 (higher scores indicate poorer outcomes).

Outcome measures

Outcome measures
Measure	Double Blind Placebo n=122 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab n=127 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Disease Specific Health-related Quality of Life (HRQoL): Change From Baseline in SinoNasal Outcome Test (SNOT-22) Score at Week 56.	-15.2 Score Standard Error 26.6	-18.0 Score Standard Error 29.6

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo).

Time to the first surgery for CRSwNP= Start date of the first surgery for CRSwNP - date of randomisation + 1

Outcome measures

Outcome measures
Measure	Double Blind Placebo n=135 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab n=139 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Time to First Nasal Polyp Surgery	7.79 Months Interval 4.4 to 12.4	6.31 Months Interval 3.3 to 10.5

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo).

Time to the first SCS use for CRSwNP = Start date of the first SCS use for CRSwNP - date of randomisation + 1

Outcome measures

Outcome measures
Measure	Double Blind Placebo n=135 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab n=139 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Time to First SCS Course for CRSwNP	6.37 Months Interval 0.1 to 11.4	5.62 Months Interval 0.1 to 13.0

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo).

Time to first surgery and/or SCS use for CRSwNP = earlier date of (start date of first surgery for CRSwNP, start date of first SCS use for CRSwNP) - date of randomisation + 1

Outcome measures

Outcome measures
Measure	Double Blind Placebo n=135 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab n=139 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Time to First NP Surgery and/or SCS Use for CRSwNP	6.37 Months Interval 0.1 to 12.4	5.70 Months Interval 0.1 to 13.0

SECONDARY outcome

Timeframe: Baseline to Week 56

The participant completed the nasal polyposis symptom diary each morning throughout the study. The participant was asked to consider their experience with nasal polyposis/nasal polyps over the past 24 hours when responding to each question. Participants were asked to report their experience with nasal polyposis symptoms (nasal blockage, nasal congestion, runny nose, postnasal drip (mucus drainage down the throat), headache, facial pain, facial pressure, difficulty with sense of smell). Participants reported the severity of each symptom and symptom impact at its worst using a 4-point verbal rating scale (0-None to 3-Severe). A total symptom score (range from 0 to 24) was calculated by taking the sum of the 8 equally weighted symptom items. Higher scores indicate greater symptom severity.

Outcome measures

Outcome measures
Measure	Double Blind Placebo n=118 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab n=114 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Change From Baseline in Bi-weekly Mean Nasal Polyps Symptom Diary Total Symptom Score at Week 56.	-2.32 Score Standard Deviation 5.83	-3.19 Score Standard Deviation 5.78

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo).

Nasal polyps surgery is defined as any procedure involving instruments resulting in incision and removal of tissue (e.g. polypectomy, endoscopic sinus surgery). An SCS course can be considered as a new course if the start date is preceded by at least 7 days after the end date of the last SCS course for CRSwNP (i.e. start date of the new course - end date of the last course \> 7)

Outcome measures

Outcome measures
Measure	Double Blind Placebo n=135 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab n=139 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Percentage of Participants With Surgery and/or Use SCS for CRSwNP	30 Participants	26 Participants

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo).

Nasal polyps surgery is defined as any procedure involving instruments resulting in incision and removal of tissue (e.g. polypectomy, endoscopic sinus surgery).

Outcome measures

Outcome measures
Measure	Double Blind Placebo n=135 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab n=139 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Percentage of Participants With Surgery for CRSwNP	10 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Primary full analysis set (All CRSwNP participants with asthma who were randomized and received any IP. N=139 in treatment group and N=135 in placebo).

An SCS course can be considered as a new course if the start date is preceded by at least 7 days after the end date of the last SCS course for CRSwNP (i.e. start date of the new course - end date of the last course \> 7)

Outcome measures

Outcome measures
Measure	Double Blind Placebo n=135 Participants 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab n=139 Participants 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.
Percentage of Participants With SCS Use for CRSwNP	22 Participants	21 Participants

Adverse Events

Double Blind Benralizumab

Serious events: 12 serious events

Other events: 78 other events

Deaths: 0 deaths

Double Blind Placebo

Serious events: 12 serious events

Other events: 59 other events

Deaths: 0 deaths

Double Blind Benralizumab First, Then Open Label Benralizumab

Serious events: 6 serious events

Other events: 37 other events

Deaths: 0 deaths

Double Blind Placebo First, Then Open Label Benralizumab

Serious events: 9 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Double Blind Benralizumab n=144 participants at risk 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Placebo n=143 participants at risk 30 mg Placebo administered every 4 weeks subcutaneously for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks (Q8W) thereafter.	Double Blind Benralizumab First, Then Open Label Benralizumab n=122 participants at risk All participants who received Benralizumab in the double-blind (DB) period and continued to receive Benralizumab in the open-label extension (OLE) period. 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 56, 60, 64) and Q8W thereafter (Weeks 72, 80, 88, 96 and 104).	Double Blind Placebo First, Then Open Label Benralizumab n=125 participants at risk All participants who initially received Placebo in the DB period, then switched to receive Benralizumab in the open-label extension (OLE) period. 30 mg Benralizumab administered every 4 weeks subcutaneously for the first 3 doses (Weeks 56, 60, 64) and Q8W thereafter (Weeks 72, 80, 88, 96 and 104).
Infections and infestations COVID-19	15.3% 22/144 • Number of events 23 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	11.2% 16/143 • Number of events 16 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	7.4% 9/122 • Number of events 9 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	5.6% 7/125 • Number of events 7 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.
Infections and infestations Influenza	0.69% 1/144 • Number of events 1 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	2.1% 3/143 • Number of events 3 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	3.3% 4/122 • Number of events 4 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	0.80% 1/125 • Number of events 1 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.
Infections and infestations Nasopharyngitis	7.6% 11/144 • Number of events 12 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	6.3% 9/143 • Number of events 10 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	7.4% 9/122 • Number of events 10 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	6.4% 8/125 • Number of events 9 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.
Infections and infestations Pneumonia	2.1% 3/144 • Number of events 3 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	0.70% 1/143 • Number of events 1 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	0.82% 1/122 • Number of events 1 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	3.2% 4/125 • Number of events 4 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.
Infections and infestations Upper respiratory tract infection	9.0% 13/144 • Number of events 16 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	9.8% 14/143 • Number of events 18 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	7.4% 9/122 • Number of events 10 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	3.2% 4/125 • Number of events 5 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 2/144 • Number of events 2 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	4.2% 6/143 • Number of events 6 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	1.6% 2/122 • Number of events 2 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	2.4% 3/125 • Number of events 3 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.
Musculoskeletal and connective tissue disorders Back pain	4.9% 7/144 • Number of events 7 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	0.70% 1/143 • Number of events 1 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	0.82% 1/122 • Number of events 1 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	1.6% 2/125 • Number of events 2 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.
Nervous system disorders Headache	7.6% 11/144 • Number of events 15 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	4.9% 7/143 • Number of events 10 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	0.82% 1/122 • Number of events 1 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	3.2% 4/125 • Number of events 9 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.
Respiratory, thoracic and mediastinal disorders Asthma	11.1% 16/144 • Number of events 20 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	15.4% 22/143 • Number of events 31 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	5.7% 7/122 • Number of events 8 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	6.4% 8/125 • Number of events 10 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.
Gastrointestinal disorders Chronic gastritis	4.2% 6/144 • Number of events 7 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	0.70% 1/143 • Number of events 1 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	0.00% 0/122 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	1.6% 2/125 • Number of events 2 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.
General disorders Influenza like illness	4.9% 7/144 • Number of events 8 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	2.8% 4/143 • Number of events 6 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	1.6% 2/122 • Number of events 2 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	0.00% 0/125 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.
General disorders Pyrexia	4.9% 7/144 • Number of events 7 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	2.1% 3/143 • Number of events 3 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	0.82% 1/122 • Number of events 1 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.	3.2% 4/125 • Number of events 5 • On study AEs were collected from the first dose to the last date in study, up to 112 weeks. AEs during DB period: date of first dose of IP in DB period ≤ AE onset date ≤ EoDB, except any AE that started on or after the date of first OLE dose was counted in the OLE and not in the DB period. • AEs during the OLE period: date of first dose of IP in OLE ≤ AE onset date ≤ study completion or withdrawal date.

Additional Information

Global Clinical Head

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

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