Trial Outcomes & Findings for Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma (NCT NCT04048343)
NCT ID: NCT04048343
Last Updated: 2022-06-01
Results Overview
The number of subjects who experienced an AE during on-treatment period was summarised.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
65 participants
Primary outcome timeframe
From first dose of study drug until last study visit at Week 64
Results posted on
2022-06-01
Participant Flow
A total of 65 subjects fulfilled all inclusion and exclusion criteria and were registered to receive treatment at 5 centres in Japan.
All registered subjects received treatment.
Participant milestones
| Measure |
Tezepelumab 210mg Q4W
Tezepelumab admistered every 4 weeks subcutaneously
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma
Baseline characteristics by cohort
| Measure |
Tezepelumab 210mg Q4W
n=65 Participants
Tezepelumab admistered every 4 weeks subcutaneously
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
|
Age, Continuous
|
51.3 Years
STANDARD_DEVIATION 12.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
65 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until last study visit at Week 64The number of subjects who experienced an AE during on-treatment period was summarised.
Outcome measures
| Measure |
Tezepelumab 210 Q4W
n=65 Participants
Tezepelumab administered every 4 weeks subcutaneously
|
|---|---|
|
Number of Subjects With Adverse Events
|
39 Participants
|
Adverse Events
Tezepelumab 210mg Q4W
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tezepelumab 210mg Q4W
n=65 participants at risk
Tezepelumab admistered every 4 weeks subcutaneously
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/65 • Number of events 1 • From first dose of study drug until last study visit at Week 64
|
|
Infections and infestations
Gastroenteritis viral
|
1.5%
1/65 • Number of events 1 • From first dose of study drug until last study visit at Week 64
|
|
Infections and infestations
Lung abscess
|
1.5%
1/65 • Number of events 1 • From first dose of study drug until last study visit at Week 64
|
|
Infections and infestations
Tonsillitis
|
1.5%
1/65 • Number of events 1 • From first dose of study drug until last study visit at Week 64
|
Other adverse events
| Measure |
Tezepelumab 210mg Q4W
n=65 participants at risk
Tezepelumab admistered every 4 weeks subcutaneously
|
|---|---|
|
General disorders
Injection site erythema
|
3.1%
2/65 • Number of events 2 • From first dose of study drug until last study visit at Week 64
|
|
Infections and infestations
Bronchitis
|
3.1%
2/65 • Number of events 3 • From first dose of study drug until last study visit at Week 64
|
|
Infections and infestations
Gastroenteritis
|
3.1%
2/65 • Number of events 2 • From first dose of study drug until last study visit at Week 64
|
|
Infections and infestations
Herpes zoster
|
4.6%
3/65 • Number of events 3 • From first dose of study drug until last study visit at Week 64
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
13/65 • Number of events 18 • From first dose of study drug until last study visit at Week 64
|
|
Infections and infestations
Oral herpes
|
3.1%
2/65 • Number of events 4 • From first dose of study drug until last study visit at Week 64
|
|
Infections and infestations
Pharyngitis
|
9.2%
6/65 • Number of events 6 • From first dose of study drug until last study visit at Week 64
|
|
Infections and infestations
Rhinitis
|
3.1%
2/65 • Number of events 2 • From first dose of study drug until last study visit at Week 64
|
|
Injury, poisoning and procedural complications
Contusion
|
4.6%
3/65 • Number of events 3 • From first dose of study drug until last study visit at Week 64
|
|
Injury, poisoning and procedural complications
Rib fracture
|
3.1%
2/65 • Number of events 2 • From first dose of study drug until last study visit at Week 64
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.6%
3/65 • Number of events 3 • From first dose of study drug until last study visit at Week 64
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.1%
2/65 • Number of events 3 • From first dose of study drug until last study visit at Week 64
|
|
Psychiatric disorders
Insomnia
|
3.1%
2/65 • Number of events 2 • From first dose of study drug until last study visit at Week 64
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
4.6%
3/65 • Number of events 4 • From first dose of study drug until last study visit at Week 64
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
2/65 • Number of events 2 • From first dose of study drug until last study visit at Week 64
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place