A Phase 2 interventional study of Tezepelumab and Placebo in Asthma, Bronchial Diseases and Respiratory Tract Diseases, sponsored by AstraZeneca. Completed at 28 sites in 5 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-02-21.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled asthma.
This is a multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled moderate-to-severe asthma, taking inhaled corticosteroids and at least one additional asthma controller. Approximately 110 subjects will be randomized globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 28-week treatment period. Although, due to the Covid-19 pandemic this may be an extended time frame for some subject visits. The study also includes a post-treatment follow-up period of 12 weeks.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 116 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Principal Inclusion Criteria:
Principal Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tezepelumab subcutaneous injection
Biological: Tezepelumab
Placebo subcutaneous injection
Other: Placebo
Tezepelumab subcutaneous injection
Placebo subcutaneous injection
Airway Submucosal Inflammatory Cells Ratio Change From Baseline to EOT.
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.
Time frame: First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
Reticular Basement Membrane (RBM) Thickness Ratio Change From Baseline to EOT.
The change from baseline to EOT expressed as a ratio i.e. (EOT/baseline) in RBM thickness, determined by microscopic evaluation of bronchoscopic biopsies.
Time frame: First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
Percent (%) Airway Epithelial Integrity Ratio Change From Baseline to EOT.
The change from baseline to EOT expressed as a ratio i.e. (EOT/baseline) in % airway epithelial, determined by microscopic evaluation of bronchoscopic biopsies.
Time frame: First dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).
116 subjects randomized to Tezepelumab 210 mg Q4W or Placebo in 1:1 treatment allocation. All randomized subjects were treated.
| Milestone | Teze 210 mg Q4W | Placebo |
|---|---|---|
| Started | 59 | 57 |
| Completed | 58 | 56 |
| Not completed | 1 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Other | 1 | 0 |
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.
| Ratio | Teze 210 mg Q4W | Placebo |
|---|---|---|
| Eosinophils | 0.11 (0.06 to 0.21) | 0.75 (0.41 to 1.38) |
| Neutrophils | 1.11 (0.88 to 1.39) | 0.81 (0.66 to 1.01) |
| T cells CD3+ | 0.91 (0.78 to 1.07) | 0.81 (0.70 to 0.95) |
| T cells CD4+ | 0.96 (0.82 to 1.14) | 0.81 (0.70 to 0.95) |
| Mast cells Tryptase+ | 0.84 (0.70 to 1.02) | 1.01 (0.84 to 1.22) |
| Mast cells Chymase+ | 1.07 (0.76 to 1.52) | 0.90 (0.65 to 1.26) |
The change from baseline to EOT expressed as a ratio i.e. (EOT/baseline) in RBM thickness, determined by microscopic evaluation of bronchoscopic biopsies.
| Ratio | Teze 210 mg Q4W | Placebo |
|---|---|---|
| Reticular Basement Membrane (RBM) Thickness Ratio Change From Baseline to EOT. | 0.87 (0.79 to 0.95) | 0.90 (0.81 to 0.99) |
The change from baseline to EOT expressed as a ratio i.e. (EOT/baseline) in % airway epithelial, determined by microscopic evaluation of bronchoscopic biopsies.
| Ratio | Teze 210 mg Q4W | Placebo |
|---|---|---|
| Intact epithelium | 0.87 (0.61 to 1.23) | 0.84 (0.59 to 1.19) |
| Damaged epithelium | 1.01 (0.92 to 1.12) | 0.95 (0.86 to 1.04) |
| Denuded epithelium | 1.05 (0.83 to 1.31) | 1.34 (1.07 to 1.68) |
Collected over From first dose of investigational product to end of treatment (EOT) at Week 28 (or up to Week 48 due to COVID19 pandemic).. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/57 (0%) | 7/57 (12.3%) | 45/57 (78.9%) |
| Teze 210 mg Q4W | 0/59 (0%) | 3/59 (5.1%) | 48/59 (81.4%) |
| Event | Placebo | Teze 210 mg Q4W |
|---|---|---|
| Post procedural complicationInjury, poisoning and procedural complications | 2/57 | 0/59 |
| MyocarditisCardiac disorders | 1/57 | 0/59 |
| Abdominal painGastrointestinal disorders | 1/57 | 0/59 |
| Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/57 | 0/59 |
| Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/57 | 0/59 |
| Urinary retentionRenal and urinary disorders | 1/57 | 0/59 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/57 | 0/59 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 0/57 | 1/59 |
| Hiatus herniaGastrointestinal disorders | 0/57 | 1/59 |
| InfluenzaInfections and infestations | 0/57 | 1/59 |
| Event | Placebo | Teze 210 mg Q4W |
|---|---|---|
| NasopharyngitisInfections and infestations | 21/57 | 22/59 |
| Post procedural complicationInjury, poisoning and procedural complications | 10/57 | 11/59 |
| HeadacheNervous system disorders | 8/57 | 6/59 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/57 | 6/59 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 2/57 | 6/59 |
| DiarrhoeaGastrointestinal disorders | 0/57 | 5/59 |
| Injection site erythemaGeneral disorders | 2/57 | 5/59 |
| Upper respiratory tract infectionInfections and infestations | 4/57 | 3/59 |
| Injection site pruritusGeneral disorders | 1/57 | 4/59 |
| Post procedural feverInjury, poisoning and procedural complications | 2/57 | 4/59 |
Full Analysis Set - Include all subjects randomised to study treatment who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.
| Age, Categorical(Participants) | Teze 210 mg Q4W | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 51 | 49 | 100 |
| >=65 years | 8 | 8 | 16 |
| Age, Continuous(Years) | Teze 210 mg Q4W | Placebo | Total |
|---|---|---|---|
| Mean | 50.4 ± 12.7 | 50.4 ± 13.9 | 50.4 ± 13.2 |
| Sex: Female, Male(Participants) | Teze 210 mg Q4W | Placebo | Total |
|---|---|---|---|
| Female | 39 | 26 | 65 |
| Male | 20 | 31 | 51 |
| Race/Ethnicity, Customized(Participants) | Teze 210 mg Q4W | Placebo | Total |
|---|---|---|---|
| White | 54 | 55 | 109 |
| Black or African American | 2 | 1 | 3 |
| Asian | 2 | 1 | 3 |
| Other (includes Native Hawaiian or Other Pacific Islander and American Indian or Alaska Native) | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Teze 210 mg Q4W | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 59 | 57 | 116 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2018 to primary completion in Nov 2020, 24 months.
Results were first posted in Feb 2022, 1 year 3 months after primary completion.
Of 137 industry-sponsored phase 2 interventional studies under Asthma, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's 24 months is above that.
Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tezepelumab