Trial Outcomes & Findings for Study to Evaluate Tezepelumab on Airway Inflammation in Adults With Uncontrolled Asthma (CASCADE) (NCT NCT03688074)
NCT ID: NCT03688074
Last Updated: 2022-02-21
Results Overview
The change from baseline to end of treatment (EOT) expressed as a ratio i.e. (EOT/baseline) in numbers of each of the airway submucosal inflammatory cells, determined by microscopic evaluation of bronchoscopic biopsies.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
Results posted on
2022-02-21
Participant Flow
116 subjects randomized to Tezepelumab 210 mg Q4W or Placebo in 1:1 treatment allocation. All randomized subjects were treated.
The study randomized subjects across the spectrum of T2 status. Randomization was stratified by screening blood eosinophil level (\<150 , 150 - \<300, \>=300 cells/µL).
Participant milestones
| Measure |
Teze 210 mg Q4W
Tezepelumab subcutaneous injection
|
Placebo
Placebo subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
57
|
|
Overall Study
COMPLETED
|
58
|
56
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Teze 210 mg Q4W
Tezepelumab subcutaneous injection
|
Placebo
Placebo subcutaneous injection
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Tezepelumab on Airway Inflammation in Adults With Uncontrolled Asthma (CASCADE)
Baseline characteristics by cohort
| Measure |
Teze 210 mg Q4W
n=59 Participants
Tezepelumab subcutaneous injection
|
Placebo
n=57 Participants
Placebo subcutaneous injection
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
50.4 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
50.4 Years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
50.4 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other (includes Native Hawaiian or Other Pacific Islander and American Indian or Alaska Native)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).Population: Number of Participants Analyzed are all subjects randomized to study treatment who completed at least 20 weeks of study treatment and had an EOT visit not greater than 8 weeks after date of last dose of IP. In order to be included in analysis, the participants also had to have a non-missing baseline as well as a non-missing EOT assessment for the respective variable.
The change from baseline to end of treatment (EOT) expressed as a ratio i.e. (EOT/baseline) in numbers of each of the airway submucosal inflammatory cells, determined by microscopic evaluation of bronchoscopic biopsies.
Outcome measures
| Measure |
Teze 210 mg Q4W
n=54 Participants
Tezepelumab subcutaneous injection
|
Placebo
n=56 Participants
Placebo subcutaneous injection
|
|---|---|---|
|
Airway Submucosal Inflammatory Cells Ratio Change From Baseline to EOT.
Eosinophils
|
0.11 Ratio
Interval 0.06 to 0.21
|
0.75 Ratio
Interval 0.41 to 1.38
|
|
Airway Submucosal Inflammatory Cells Ratio Change From Baseline to EOT.
Neutrophils
|
1.11 Ratio
Interval 0.88 to 1.39
|
0.81 Ratio
Interval 0.66 to 1.01
|
|
Airway Submucosal Inflammatory Cells Ratio Change From Baseline to EOT.
T cells CD3+
|
0.91 Ratio
Interval 0.78 to 1.07
|
0.81 Ratio
Interval 0.7 to 0.95
|
|
Airway Submucosal Inflammatory Cells Ratio Change From Baseline to EOT.
T cells CD4+
|
0.96 Ratio
Interval 0.82 to 1.14
|
0.81 Ratio
Interval 0.7 to 0.95
|
|
Airway Submucosal Inflammatory Cells Ratio Change From Baseline to EOT.
Mast cells Tryptase+
|
0.84 Ratio
Interval 0.7 to 1.02
|
1.01 Ratio
Interval 0.84 to 1.22
|
|
Airway Submucosal Inflammatory Cells Ratio Change From Baseline to EOT.
Mast cells Chymase+
|
1.07 Ratio
Interval 0.76 to 1.52
|
0.90 Ratio
Interval 0.65 to 1.26
|
SECONDARY outcome
Timeframe: First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).Population: All subjects randomised to study treatment who completed at least 20 weeks of study treatment and had a baseline assessment and an EOT assessment not greater than 8 weeks after date of last dose of IP.
The change from baseline to EOT expressed as a ratio i.e. (EOT/baseline) in RBM thickness, determined by microscopic evaluation of bronchoscopic biopsies.
Outcome measures
| Measure |
Teze 210 mg Q4W
n=42 Participants
Tezepelumab subcutaneous injection
|
Placebo
n=40 Participants
Placebo subcutaneous injection
|
|---|---|---|
|
Reticular Basement Membrane (RBM) Thickness Ratio Change From Baseline to EOT.
|
0.87 Ratio
Interval 0.79 to 0.95
|
0.90 Ratio
Interval 0.81 to 0.99
|
SECONDARY outcome
Timeframe: First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).Population: Number of Participants Analyzed are all subjects randomized to study treatment who completed at least 20 weeks of study treatment and had an EOT visit not greater than 8 weeks after date of last dose of IP. In order to be included in analysis, the participants also had to have a non-missing baseline as well as a non-missing EOT assessment for the respective variable.
The change from baseline to EOT expressed as a ratio i.e. (EOT/baseline) in % airway epithelial, determined by microscopic evaluation of bronchoscopic biopsies.
Outcome measures
| Measure |
Teze 210 mg Q4W
n=54 Participants
Tezepelumab subcutaneous injection
|
Placebo
n=56 Participants
Placebo subcutaneous injection
|
|---|---|---|
|
Percent (%) Airway Epithelial Integrity Ratio Change From Baseline to EOT.
Intact epithelium
|
0.87 Ratio
Interval 0.61 to 1.23
|
0.84 Ratio
Interval 0.59 to 1.19
|
|
Percent (%) Airway Epithelial Integrity Ratio Change From Baseline to EOT.
Damaged epithelium
|
1.01 Ratio
Interval 0.92 to 1.12
|
0.95 Ratio
Interval 0.86 to 1.04
|
|
Percent (%) Airway Epithelial Integrity Ratio Change From Baseline to EOT.
Denuded epithelium
|
1.05 Ratio
Interval 0.83 to 1.31
|
1.34 Ratio
Interval 1.07 to 1.68
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 45 other events
Deaths: 0 deaths
Teze 210 mg Q4W
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=57 participants at risk
Placebo subcutaneous injection
|
Teze 210 mg Q4W
n=59 participants at risk
Tezepelumab subcutaneous injection
|
|---|---|---|
|
Cardiac disorders
Myocarditis
|
1.8%
1/57 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
0.00%
0/59 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
1/57 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
0.00%
0/59 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
1.7%
1/59 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
1.7%
1/59 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Influenza
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
1.7%
1/59 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
0.00%
0/59 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
1.7%
1/59 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
1.8%
1/57 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
0.00%
0/59 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.8%
1/57 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
0.00%
0/59 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Renal and urinary disorders
Urinary retention
|
1.8%
1/57 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
0.00%
0/59 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.8%
1/57 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
0.00%
0/59 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
Other adverse events
| Measure |
Placebo
n=57 participants at risk
Placebo subcutaneous injection
|
Teze 210 mg Q4W
n=59 participants at risk
Tezepelumab subcutaneous injection
|
|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
8.5%
5/59 • Number of events 6 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Gastrointestinal disorders
Nausea
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
3/57 • Number of events 3 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
General disorders
Influenza like illness
|
5.3%
3/57 • Number of events 3 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
5.1%
3/59 • Number of events 3 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
General disorders
Injection site erythema
|
3.5%
2/57 • Number of events 12 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
8.5%
5/59 • Number of events 14 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
General disorders
Injection site granuloma
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
General disorders
Injection site pruritus
|
1.8%
1/57 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
6.8%
4/59 • Number of events 5 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
General disorders
Oedema peripheral
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
5.1%
3/59 • Number of events 3 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
General disorders
Pyrexia
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
5.1%
3/59 • Number of events 3 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Candida infection
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Chronic sinusitis
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
0.00%
0/59 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Gastroenteritis
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
1.7%
1/59 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Lower respiratory tract infection
|
1.8%
1/57 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
1.7%
1/59 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Nasopharyngitis
|
36.8%
21/57 • Number of events 22 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
37.3%
22/59 • Number of events 28 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 4 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Pneumonia
|
1.8%
1/57 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Rhinitis
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
1.7%
1/59 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Sinusitis
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
0.00%
0/59 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
4/57 • Number of events 4 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
5.1%
3/59 • Number of events 3 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Infections and infestations
Urinary tract infection
|
3.5%
2/57 • Number of events 5 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
5.1%
3/59 • Number of events 4 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 5 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
1/57 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 4 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
17.5%
10/57 • Number of events 12 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
18.6%
11/59 • Number of events 11 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
6.8%
4/59 • Number of events 4 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/57 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
5.1%
3/59 • Number of events 3 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
3/57 • Number of events 4 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
5.1%
3/59 • Number of events 3 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
0.00%
0/59 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.5%
2/57 • Number of events 3 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
1.7%
1/59 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
1/57 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
5.1%
3/59 • Number of events 3 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Nervous system disorders
Headache
|
14.0%
8/57 • Number of events 8 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
10.2%
6/59 • Number of events 9 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
4/57 • Number of events 5 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
10.2%
6/59 • Number of events 9 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
3.4%
2/59 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
1.7%
1/59 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
10.2%
6/59 • Number of events 6 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
|
Vascular disorders
Hypertension
|
3.5%
2/57 • Number of events 2 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
1.7%
1/59 • Number of events 1 • From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place