A Phase 2 interventional study of Tozorakimab and Placebo in Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis, sponsored by AstraZeneca. Completed at 90 sites in 15 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult participants with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.
Study D9180C00002 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy and safety of MEDI3506 in adult participants with moderate to severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.
Approximately 85 sites globally will participate in this study. Approximately 144 participants will be randomized to 2 treatment groups in a 1:1 ratio to receive MEDI3506 or placebo.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's enrollment of 137 is above the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.
Browse Bronchitis, Chronic 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.
Compared within Bronchitis, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pulmonary Disease, Chronic Obstructive. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Chest CT scan findings requiring further investigation or repeat CT surveillance before SV14.
Additional inclusion and exclusion criteria's applies.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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 share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Participants received 7 doses of subcutaneous (SC) tozorakimab Dose Level 1 injection once every 4 weeks (Q4W).
Drug: Tozorakimab
Participants received 7 doses of SC placebo injection matched to tozorakimab once Q4W.
Other: Placebo
Participants will receive SC injection of tozorakimab as stated in arm description.
Also known as: MEDI3506
Participants will receive SC injection of placebo as stated in arm description.
Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic
The mean change from baseline in Pre-BD FEV1 at Week 12 (tozorakimab - placebo) estimated using a repeated measures mixed effects analysis of covariance measures was estimated. Data available from all visits up to and including Week 12, irrespective of whether the participant discontinued study drug or received reliever therapy was considered. FEV1 was measured by spirometry at clinic.
Time frame: Baseline (Day -35 to Day -28) through Week 12
Serum Tozorakimab Concentration
Serum concentration of tozorakimab collected over time are reported. The lower limit of quantification (LLOQ) for tozorakimab was considered to be 10 μg/L.
Time frame: Post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36
Number of Participants With Positive Anti-drug Antibodies (ADA) to Tozorakimab
Number of participants with positive ADA to tozorakimab are reported. Treatment-induced ADA positive is defined as ADA negative at baseline and positive at post-baseline assessment. Treatment-boosted ADA positive is defined as ADA positive at baseline and boosted (\>= 4 fold) the pre-existing titre during the study period. Persistent positive is defined as ADA negative at baseline and positive at \>= 2 post-baseline assessments (with \>= 16 weeks between first and last positive) or ADA positive at last post-baseline assessment. Transiently positive is defined as ADA negative at baseline and at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
Time frame: Pre-dose at Study Weeks 0 (baseline) and post-dose at Study Weeks 2, 4, 12, 20, 24, 28, 32, and 36
Number of Participants Experiencing First Chronic Obstructive Pulmonary Disease Composite Exacerbations (COPDCompEx) Event
The COPDCompEx combines exacerbations with events defined from participant e-Diaries and peak expiratory flow (PEF). COPDCompEx defined exacerbations included episodes leading to one or more of the following: hospitalization, emergency room visit, treatment with systemic corticosteroids (injected and/or oral), or treatment with antibiotics. Diary COPDCompEx events are defined by threshold and slope criteria being met for \>= 2 consecutive days using the following diary and home spirometry variables: overall symptom rating, night-time awakenings due to symptoms, reliever medication use, PEF.
Time frame: Baseline (Day -35 to Day -28) through Week 28
Change From Baseline to Week 12 in 4-weekly Mean Evaluating Respiratory Symptoms of COPD (E-RS:COPD) Total Score
Change from baseline to Week 12 in 4-weekly mean E-RS:COPD total score is reported. The E-RS™:COPD is an 11-item electronic patient reported outcome (ePRO) questionnaires developed to evaluate the severity of respiratory symptoms of COPD including breathlessness (5 items; score range: 0 to 17), cough and sputum (3 items; score range: 0 to 11), and chest symptoms (3 items; score range: 0 to 12). The ePRO was completed every day at home and at site visits. Summation of E-RS:COPD item responses produced a total score ranging from 0 to 40, with higher scores indicating greater severity. The 4-weekly mean will be calculated as the sum of all non-missing daily scores over the 28-day evaluation period, divided by the number of non-missing daily scores.
Time frame: Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12
Change From Baseline to Week 12 in Mean Breathlessness, Cough and Sputum Scale (BCSS) Score (Over the Previous 4 Weeks)
Change from baseline to Week 12 in mean BCSS score (over the previous 4 weeks) is reported. The BCSS was a 3-item daily diary that assesses the severity of the 3 symptoms: breathlessness, sputum, and cough, each on a 5-point Likert scale ranging from 0 (no symptoms) to 4 (severe symptoms). Item scores were summed to yield a total score ranging from 0 to 12; wherein higher total score indicated more severe symptoms. The BCSS was captured each evening via eDiary. The 4-weekly mean BCSS score was calculated as the sum of all non-missing daily scores over the 28-dayevaluation period, divided by the number of non-missing daily scores.
Time frame: Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12
Change From Baseline to Week 12 in Cough Visual Analogue Scale (VAS) Score
Change from baseline to Week 12 in cough VAS score is reported. Participants were asked to complete a cough severity VAS (100 mm linear scale marked with a horizontal line by the participant, with 0 mm representing ''no cough'' and 100 mm representing "worst cough") that measured subjective assessment by the participant of the prior 24 hrs for severity of cough symptoms. It was completed each evening in the eDiary. The 4-weekly mean cough VAS score was calculated as the sum of all non-missing daily scores over the 28-day evaluation period, divided by the number of non-missing daily scores.
Time frame: Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12
Change From Baseline to Week 12 in Saint George's Respiratory Questionnaire (SGRQ) Total Score
Change from baseline to Week 12 in SGRQ total score is reported. The SGRQ was a 50-item electronic PRO instrument developed to measure the health status of participants with airway obstruction diseases and is divided into 2 parts. Part 1 consisted 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; Part 2 consisted 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yielded a total score and three domain scores (symptoms, activity, and impacts). The total score indicated the impact of disease on overall health status, which was expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status. The domain scores range from 0 to 100, with higher scores indicative of greater impairment.
Time frame: Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12
Percentage of Participants With a Decrease in SGRQ Total Score of >= 4 Points From Baseline to Week 12
Percentage of participants with a decrease in SGRQ total score of \>= 4 points from baseline to Week 12 is reported. The SGRQ was a 50-item electronic PRO instrument developed to measure the health status of participants with airway obstruction diseases and is divided into 2 parts. Part 1 consisted 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; Part 2 consisted 42 items related to the daily activity and psychosocial impacts of individual's respiratory condition. SGRQ yielded a total score and three domain scores (symptoms, activity, and impacts). Total score indicated the impact of disease on overall health status, which was expressed as a percentage of overall impairment, in which 100 represents worst possible health status and 0 indicates best possible health status. The domain scores range from 0 to 100, with higher scores indicative of greater impairment. A change of 4 units/points is associated with a minimum clinically important difference.
Time frame: Baseline (from evening of Study Day -14 to the morning of Study Day 1) through Week 12
Change From Baseline to Week 12 in Airwave Oscillometry (AO) Parameters
Change from baseline to Week 12 in AO parameters including frequency dependence of resistance at 5-20 Hz (R5-R20) and respiratory resistance at 5 Hz (R5; total airway resistance) and 20 Hz (R20; resistance of large airways) is reported. AO is a non-invasive lung function test assessed using an AO device. It is assessed during quiet, tidal breathing with no participant effort required, by superimposing a multi-frequency oscillation onto the participant's natural breathing. AO device uses a vibrating mesh to generate a multifrequency sinusoidal pseudorandom noise (PRN) signal. The AO markers; respiratory resistance at 5 Hz (R5) and 20 Hz (R20) and difference between resistance at 5 and 20Hz (R5-R20; resistance in small airways) are recorded. These markers measure peripheral airway resistance.
Time frame: Baseline (Study Day 1) and Week 12
Change From Baseline to Week 12 in AO Parameter-Area Under the Reactance Curve (AX)
Change from baseline to Week 12 in AO Parameter-Area Under the Reactance Curve (AX) is reported. AO is a non-invasive lung function test assessed using an AO device. It is assessed during quiet, tidal breathing with no participant effort required, by superimposing a multi-frequency oscillation onto the participant's natural breathing.
Time frame: Baseline (Study Day 1) and Week 12
Ratio to Baseline in Daily, Night-time, and Awake Time Cough Frequency at Week 12
Ratio to baseline in daily, night-time, and awake time cough frequency at Week 12 is reported. Objective cough frequency was measured using an ambulatory cough monitoring (ACM) which was fitted and worn by the participants for approximately 24 hours after the visits. Daily cough frequency as full average hourly cough of the full duration of recording, night time cough frequency as sleep average hourly cough of the duration of recording at night, and awake time cough frequency as awake average hourly cough of the full duration of recording minus sleep recording will be derived from the recording.
Time frame: Baseline (Day -21 to Day -7) and Week 12
Change From Baseline in Pre-BD FEV1 and Post-BD FEV1 Through Week 28 in Participants With Extent of Emphysema < 10%
Change from baseline in pre-BD FEV1 and post-BD FEV1 through Week 28 in participants with extent of emphysema \< 10% is reported.
Time frame: Baseline (Week -5 to -4) through Week 28 post-dose
Change From Baseline in Pre-BD FEV1 and Post-BD FEV1 Through Week 28 in Participants With Extent of Emphysema >= 10%
Change from baseline in pre-BD FEV1 and post-BD FEV1 through Week 28 in participants with extent of emphysema \>= 10% is reported.
Time frame: Baseline (Week -5 to -4) through Week 28 post-dose
Change From Baseline in Pre-BD and Post-BD Forced Vital Capacity (FVC) Through Week 28 in Participants With Extent of Emphysema < 10%
Change from baseline in pre-BD and post-BD FVC through Week 28 in participants with extent of emphysema \< 10% is reported.
Time frame: Baseline (Week -5 to -4) through Week 28 post-dose
Change From Baseline in Pre-BD and Post-BD FVC Through Week 28 in Participants With Extent of Emphysema >= 10%
Change from baseline in pre-BD and post-BD FVC through Week 28 in participants with extent of emphysema \>= 10% is reported.
Time frame: Baseline (Week -5 to -4) through Week 28 post-dose
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse event of special interest (AESI) are AEs of scientific and medical interest specific to understanding of tozorakimab and requires close monitoring. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time frame: Day 1 through 253 days (maximum observed duration)
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (oral or tympanic temperature, diastolic blood pressure, systolic blood pressure, heart \[pulse\] rate, and respiratory rate).
Time frame: Day 1 through 253 days (maximum observed duration)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of clinical chemistry, hematology, endocrinology, and urinalysis.
Time frame: Day 1 through 253 days (maximum observed duration)
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs
Number of participants with abnormal ECGs reported as TEAEs are reported.
Time frame: Day 1 through 253 days (maximum observed duration)
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram
Change from baseline in LVEF as measured by echocardiogram is reported.
Time frame: Baseline (Week -3 to -1) through Week 28
Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level
Change in NT-proBNP Level from baseline is reported.
Time frame: Baseline (Day -35 to Day -28) through Week 28
Number of Participants With Coronavirus Disease 2019 (COVID-19) Related AEs and SAEs
The number of participants with COVID-19 related AEs and SAEs are reported.
Time frame: Day 1 through 253 days (maximum observed duration)
Number of Participants Seropositive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Number of participants who were seronegative at baseline and who had positive SARS-Cov-2 serology result at the end of study is reported.
Time frame: Baseline (Week 0) through Week 28
Change From Baseline in Post-BD FEV1 To Weeks 12 and 28
Change from baseline in post-BD FEV1 to Weeks 12 and 28 is reported.
Time frame: Baseline (Week -5 to -4) to Weeks 12 and 28 post-dose
The study was conducted at 47 centers in 12 countries (Australia, Canada, Czech Republic, Denmark, Germany, United Kingdom, Hungary, Israel, Poland, South Africa, Spain, and USA).
| Milestone | Tozorakimab | Placebo |
|---|---|---|
| Started | 69 | 68 |
| Treated | 67 | 68 |
| Completed | 58 | 63 |
| Not completed | 11 | 5 |
| Withdrew: Adverse event | 3 | 0 |
| Withdrew: Withdrawal by subject | 5 | 4 |
| Withdrew: Reason unspecified | 1 | 0 |
| Withdrew: Failure to meet randomization criteria | 2 | 1 |
The mean change from baseline in Pre-BD FEV1 at Week 12 (tozorakimab - placebo) estimated using a repeated measures mixed effects analysis of covariance measures was estimated. Data available from all visits up to and including Week 12, irrespective of whether the participant discontinued study drug or received reliever therapy was considered. FEV1 was measured by spirometry at clinic.
| Litre | Tozorakimab | Placebo |
|---|---|---|
| Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic | 0.019 ± 0.026 | -0.005 ± 0.025 |
Serum concentration of tozorakimab collected over time are reported. The lower limit of quantification (LLOQ) for tozorakimab was considered to be 10 μg/L.
| μg/L | Tozorakimab |
|---|---|
| Week 2 | 24604.70 ± 43934.55 |
| Week 4 | 8041.59 ± 22355.66 |
| Week 12 | 7548.78 ± 6416.68 |
| Week 20 | 10789.81 ± 31903.70 |
| Week 24 | 6410.05 ± 4123.46 |
| Week 28 | 7289.36 ± 5331.35 |
| Week 32 | 1483.19 ± 1779.88 |
| Week 36 | 420.13 ± 701.12 |
Number of participants with positive ADA to tozorakimab are reported. Treatment-induced ADA positive is defined as ADA negative at baseline and positive at post-baseline assessment. Treatment-boosted ADA positive is defined as ADA positive at baseline and boosted (\>= 4 fold) the pre-existing titre during the study period. Persistent positive is defined as ADA negative at baseline and positive at \>= 2 post-baseline assessments (with \>= 16 weeks between first and last positive) or ADA positive at last post-baseline assessment. Transiently positive is defined as ADA negative at baseline and at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.
| Participants | Tozorakimab | Placebo |
|---|---|---|
| Treatment-induced ADA | 1 | 0 |
| Treatment-boosted ADA | 0 | 0 |
| Persistently positive ADA | 0 | 0 |
| Transiently positive ADA | 1 | 0 |
The COPDCompEx combines exacerbations with events defined from participant e-Diaries and peak expiratory flow (PEF). COPDCompEx defined exacerbations included episodes leading to one or more of the following: hospitalization, emergency room visit, treatment with systemic corticosteroids (injected and/or oral), or treatment with antibiotics. Diary COPDCompEx events are defined by threshold and slope criteria being met for \>= 2 consecutive days using the following diary and home spirometry variables: overall symptom rating, night-time awakenings due to symptoms, reliever medication use, PEF.
| Participants | Tozorakimab | Placebo |
|---|---|---|
| Number of Participants Experiencing First Chronic Obstructive Pulmonary Disease Composite Exacerbations (COPDCompEx) Event | 28 | 36 |
Change from baseline to Week 12 in 4-weekly mean E-RS:COPD total score is reported. The E-RS™:COPD is an 11-item electronic patient reported outcome (ePRO) questionnaires developed to evaluate the severity of respiratory symptoms of COPD including breathlessness (5 items; score range: 0 to 17), cough and sputum (3 items; score range: 0 to 11), and chest symptoms (3 items; score range: 0 to 12). The ePRO was completed every day at home and at site visits. Summation of E-RS:COPD item responses produced a total score ranging from 0 to 40, with higher scores indicating greater severity. The 4-weekly mean will be calculated as the sum of all non-missing daily scores over the 28-day evaluation period, divided by the number of non-missing daily scores.
| Units on a scale | Tozorakimab | Placebo |
|---|---|---|
| Change From Baseline to Week 12 in 4-weekly Mean Evaluating Respiratory Symptoms of COPD (E-RS:COPD) Total Score | -6.09 ± 1.004 | -6.06 ± 0.962 |
Change from baseline to Week 12 in mean BCSS score (over the previous 4 weeks) is reported. The BCSS was a 3-item daily diary that assesses the severity of the 3 symptoms: breathlessness, sputum, and cough, each on a 5-point Likert scale ranging from 0 (no symptoms) to 4 (severe symptoms). Item scores were summed to yield a total score ranging from 0 to 12; wherein higher total score indicated more severe symptoms. The BCSS was captured each evening via eDiary. The 4-weekly mean BCSS score was calculated as the sum of all non-missing daily scores over the 28-dayevaluation period, divided by the number of non-missing daily scores.
| Units on a scale | Tozorakimab | Placebo |
|---|---|---|
| Change From Baseline to Week 12 in Mean Breathlessness, Cough and Sputum Scale (BCSS) Score (Over the Previous 4 Weeks) | -2.18 ± 0.313 | -2.18 ± 0.298 |
Change from baseline to Week 12 in cough VAS score is reported. Participants were asked to complete a cough severity VAS (100 mm linear scale marked with a horizontal line by the participant, with 0 mm representing ''no cough'' and 100 mm representing "worst cough") that measured subjective assessment by the participant of the prior 24 hrs for severity of cough symptoms. It was completed each evening in the eDiary. The 4-weekly mean cough VAS score was calculated as the sum of all non-missing daily scores over the 28-day evaluation period, divided by the number of non-missing daily scores.
| mm | Tozorakimab | Placebo |
|---|---|---|
| Change From Baseline to Week 12 in Cough Visual Analogue Scale (VAS) Score | -17.21 ± 3.639 | -17.70 ± 3.483 |
Change from baseline to Week 12 in SGRQ total score is reported. The SGRQ was a 50-item electronic PRO instrument developed to measure the health status of participants with airway obstruction diseases and is divided into 2 parts. Part 1 consisted 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; Part 2 consisted 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yielded a total score and three domain scores (symptoms, activity, and impacts). The total score indicated the impact of disease on overall health status, which was expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status. The domain scores range from 0 to 100, with higher scores indicative of greater impairment.
| Units on a scale | Tozorakimab | Placebo |
|---|---|---|
| Change From Baseline to Week 12 in Saint George's Respiratory Questionnaire (SGRQ) Total Score | -9.177 ± 2.116 | -8.273 ± 2.029 |
Percentage of participants with a decrease in SGRQ total score of \>= 4 points from baseline to Week 12 is reported. The SGRQ was a 50-item electronic PRO instrument developed to measure the health status of participants with airway obstruction diseases and is divided into 2 parts. Part 1 consisted 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; Part 2 consisted 42 items related to the daily activity and psychosocial impacts of individual's respiratory condition. SGRQ yielded a total score and three domain scores (symptoms, activity, and impacts). Total score indicated the impact of disease on overall health status, which was expressed as a percentage of overall impairment, in which 100 represents worst possible health status and 0 indicates best possible health status. The domain scores range from 0 to 100, with higher scores indicative of greater impairment. A change of 4 units/points is associated with a minimum clinically important difference.
| Percentage of Participants | Tozorakimab | Placebo |
|---|---|---|
| Percentage of Participants With a Decrease in SGRQ Total Score of >= 4 Points From Baseline to Week 12 | 61.3 (0.62 to 1.58) | 61.5 |
Change from baseline to Week 12 in AO parameters including frequency dependence of resistance at 5-20 Hz (R5-R20) and respiratory resistance at 5 Hz (R5; total airway resistance) and 20 Hz (R20; resistance of large airways) is reported. AO is a non-invasive lung function test assessed using an AO device. It is assessed during quiet, tidal breathing with no participant effort required, by superimposing a multi-frequency oscillation onto the participant's natural breathing. AO device uses a vibrating mesh to generate a multifrequency sinusoidal pseudorandom noise (PRN) signal. The AO markers; respiratory resistance at 5 Hz (R5) and 20 Hz (R20) and difference between resistance at 5 and 20Hz (R5-R20; resistance in small airways) are recorded. These markers measure peripheral airway resistance.
| kPa*s/L | Tozorakimab | Placebo |
|---|---|---|
| R5-R20 | 0.008 ± 0.013 | -0.014 ± 0.013 |
| R5 | 0.015 ± 0.032 | -0.030 ± 0.030 |
| R20 | 0.006 ± 0.024 | -0.017 ± 0.023 |
Change from baseline to Week 12 in AO Parameter-Area Under the Reactance Curve (AX) is reported. AO is a non-invasive lung function test assessed using an AO device. It is assessed during quiet, tidal breathing with no participant effort required, by superimposing a multi-frequency oscillation onto the participant's natural breathing.
| kPa/L | Tozorakimab | Placebo |
|---|---|---|
| Change From Baseline to Week 12 in AO Parameter-Area Under the Reactance Curve (AX) | -0.081 ± 0.375 | -0.267 ± 0.360 |
Ratio to baseline in daily, night-time, and awake time cough frequency at Week 12 is reported. Objective cough frequency was measured using an ambulatory cough monitoring (ACM) which was fitted and worn by the participants for approximately 24 hours after the visits. Daily cough frequency as full average hourly cough of the full duration of recording, night time cough frequency as sleep average hourly cough of the duration of recording at night, and awake time cough frequency as awake average hourly cough of the full duration of recording minus sleep recording will be derived from the recording.
| Ratio to baseline | Tozorakimab | Placebo |
|---|---|---|
| Daily cough frequency | 0.89 (0.74 to 1.07) | 0.83 (0.70 to 0.99) |
| Night-time cough frequency | 1.03 (0.62 to 1.70) | 0.61 (0.38 to 0.98) |
| Awake time cough frequency | 0.89 (0.74 to 1.07) | 0.84 (0.71 to 0.99) |
Change from baseline in pre-BD FEV1 and post-BD FEV1 through Week 28 in participants with extent of emphysema \< 10% is reported.
| Litre | Tozorakimab | Placebo |
|---|---|---|
| Pre-BD FEV1 | 0.031 ± 0.057 | 0.006 ± 0.049 |
| Post-BD FEV1 | -0.039 ± 0.071 | -0.018 ± 0.059 |
Change from baseline in pre-BD FEV1 and post-BD FEV1 through Week 28 in participants with extent of emphysema \>= 10% is reported.
| Litre | Tozorakimab | Placebo |
|---|---|---|
| Pre-BD FEV1 Week 28 | -0.015 ± 0.036 | -0.068 ± 0.034 |
| Post-BD FEV1 Week 28 | 0.074 ± 0.044 | -0.053 ± 0.042 |
Change from baseline in pre-BD and post-BD FVC through Week 28 in participants with extent of emphysema \< 10% is reported.
| Litre | Tozorakimab | Placebo |
|---|---|---|
| Pre-BD FVC Week 28 | -0.143 ± 0.105 | -0.056 ± 0.093 |
| Post-BD FVC Week 28 | -0.121 ± 0.114 | 0.046 ± 0.096 |
Change from baseline in pre-BD and post-BD FVC through Week 28 in participants with extent of emphysema \>= 10% is reported.
| Litre | Tozorakimab | Placebo |
|---|---|---|
| Pre-BD FVC Week 28 | 0.089 ± 0.086 | -0.121 ± 0.084 |
| Post-BD FVC Week 28 | 0.081 ± 0.081 | -0.094 ± 0.077 |
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse event of special interest (AESI) are AEs of scientific and medical interest specific to understanding of tozorakimab and requires close monitoring. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
| Participants | Tozorakimab | Placebo |
|---|---|---|
| Any TEAEs | 53 | 50 |
| Any TESAEs | 14 | 9 |
| Any TEAESIs | 33 | 24 |
Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (oral or tympanic temperature, diastolic blood pressure, systolic blood pressure, heart \[pulse\] rate, and respiratory rate).
| Participants | Tozorakimab | Placebo |
|---|---|---|
| Hypertension | 2 | 3 |
| Hypotension | 1 | 0 |
| Dyspnoea | 2 | 3 |
| Pyrexia | 1 | 0 |
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of clinical chemistry, hematology, endocrinology, and urinalysis.
| Participants | Tozorakimab | Placebo |
|---|---|---|
| Anaemia | 0 | 1 |
| Hypercholesterolaemia | 0 | 1 |
| Hyperuricaemia | 0 | 1 |
| Hypertransaminasaemia | 1 | 0 |
| Haematuria | 2 | 0 |
| SARS-CoV-2 test positive | 2 | 0 |
| Hyperthyroidism | 0 | 1 |
| Hypothyroidism | 1 | 0 |
| Urinary tract infection | 0 | 1 |
Number of participants with abnormal ECGs reported as TEAEs are reported.
| Participants | Tozorakimab | Placebo |
|---|---|---|
| Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs | 1 | 0 |
Change from baseline in LVEF as measured by echocardiogram is reported.
| Ratio | Tozorakimab | Placebo |
|---|---|---|
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram | 0.9 ± 5.78 | 0.2 ± 4.61 |
Change in NT-proBNP Level from baseline is reported.
| pmol/L | Tozorakimab | Placebo |
|---|---|---|
| Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level | 4.051 ± 17.937 | 1.948 ± 14.280 |
The number of participants with COVID-19 related AEs and SAEs are reported.
| Participants | Tozorakimab | Placebo |
|---|---|---|
| COVID-19 related AEs | 17 | 14 |
| COVID-19 related SAEs | 1 | 0 |
Number of participants who were seronegative at baseline and who had positive SARS-Cov-2 serology result at the end of study is reported.
| Participants | Tozorakimab | Placebo |
|---|---|---|
| Number of Participants Seropositive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | 6 | 6 |
Change from baseline in post-BD FEV1 to Weeks 12 and 28 is reported.
| Litre | Tozorakimab | Placebo |
|---|---|---|
| Week 12 | 0.041 ± 0.036 | -0.025 ± 0.033 |
| Week 28 | 0.021 ± 0.036 | -0.049 ± 0.033 |
Collected over Day 1 through 253 days (maximum observed duration). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tozorakimab | 0/67 (0%) | 14/67 (20.9%) | 40/67 (59.7%) |
| Placebo | 0/68 (0%) | 9/68 (13.2%) | 39/68 (57.4%) |
| Event | Tozorakimab | Placebo |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 6/67 | 6/68 |
| Acetabulum fractureInjury, poisoning and procedural complications | 1/67 | 0/68 |
| Wrist fractureInjury, poisoning and procedural complications | 1/67 | 0/68 |
| DehydrationMetabolism and nutrition disorders | 1/67 | 0/68 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/67 | 0/68 |
| Transitional cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/67 | 0/68 |
| Transient ischaemic attackNervous system disorders | 1/67 | 0/68 |
| PancreatitisGastrointestinal disorders | 1/67 | 0/68 |
| Covid-19Infections and infestations | 1/67 | 0/68 |
| InfluenzaInfections and infestations | 1/67 | 0/68 |
| Event | Tozorakimab | Placebo |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 26/67 | 27/68 |
| Covid-19Infections and infestations | 14/67 | 14/68 |
| Injection site erythemaGeneral disorders | 10/67 | 0/68 |
| HeadacheNervous system disorders | 8/67 | 3/68 |
| NasopharyngitisInfections and infestations | 3/67 | 7/68 |
As-treated population included all participants who received any study drug and were analyzed according to the treatment they actually received.
| Age, Continuous(Years) | Tozorakimab | Placebo | Total |
|---|---|---|---|
| Mean | 64.5 ± 8.3 | 64.3 ± 6.1 | 64.4 ± 7.22 |
| Sex: Female, Male(Participants) | Tozorakimab | Placebo | Total |
|---|---|---|---|
| Female | 26 | 27 | 53 |
| Male | 41 | 41 | 82 |
| Ethnicity (NIH/OMB)(Participants) | Tozorakimab | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 66 | 66 | 132 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Tozorakimab | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 64 | 65 | 129 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
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Studies of the drug tested here: Tozorakimab