Trial Outcomes & Findings for A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease (NCT NCT01448850)
NCT ID: NCT01448850
Last Updated: 2017-01-30
Results Overview
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.
COMPLETED
PHASE2
464 participants
Day 1 up to 393
2017-01-30
Participant Flow
A total of 464 participants were screened and 324 participants were randomized into the study.
Participant milestones
| Measure |
Placebo
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
160
|
|
Overall Study
COMPLETED
|
130
|
120
|
|
Overall Study
NOT COMPLETED
|
34
|
40
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
|---|---|---|
|
Overall Study
Death
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
13
|
21
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Other
|
15
|
12
|
Baseline Characteristics
A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=164 Participants
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
n=160 Participants
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 6.8 • n=99 Participants
|
62.8 years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
62.9 years
STANDARD_DEVIATION 6.8 • n=206 Participants
|
|
Gender
Female
|
54 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Gender
Male
|
110 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
220 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 393Population: Modified intent-to-treat (mITT) population included all participants who were randomized into the study and received any investigational product.
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.
Outcome measures
| Measure |
Placebo
n=164 Participants
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
n=160 Participants
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
|---|---|---|
|
Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
|
0.78 AECOPD events/year
Interval 0.63 to 0.96
|
0.71 AECOPD events/year
Interval 0.57 to 0.9
|
SECONDARY outcome
Timeframe: Day 1 up to 393Population: The mITT population included all participants who were randomized into the study and received any investigational product.
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.
Outcome measures
| Measure |
Placebo
n=164 Participants
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
n=160 Participants
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
|---|---|---|
|
Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
|
0.14 AECOPD events/year
Interval 0.09 to 0.21
|
0.10 AECOPD events/year
Interval 0.06 to 0.16
|
SECONDARY outcome
Timeframe: Day 1 up to 393Population: The mITT population included all participants who were randomized into the study and received any investigational product.
Time to first worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Mild exacerbations require treatment with an increase in usual therapy, e.g., increase use of short acting bronchodilators. Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization.
Outcome measures
| Measure |
Placebo
n=164 Participants
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
n=160 Participants
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
|---|---|---|
|
Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
|
NA days
Interval 173.0 to
Median and upper limit of 95% confidence interval (CI) were not evaluable as less than 50% of the participants had moderate or severe AECOPD.
|
NA days
Interval 134.0 to
Median and upper limit of 95% confidence interval (CI) were not evaluable as less than 50% of the participants had moderate or severe AECOPD.
|
SECONDARY outcome
Timeframe: Baseline and Week 53Population: The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.
Outcome measures
| Measure |
Placebo
n=164 Participants
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
n=160 Participants
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
|---|---|---|
|
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53
Change at Week 53: Total Score (n=134, 123)
|
-2.76 units on scale
Standard Error 1.069
|
-2.22 units on scale
Standard Error 1.101
|
|
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53
Change at Week 53: Activity Score (n=134, 123)
|
-1.15 units on scale
Standard Error 1.306
|
-1.38 units on scale
Standard Error 1.348
|
|
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53
Change at Week 53: Impacts Score (n=134, 123)
|
-2.91 units on scale
Standard Error 1.326
|
-1.08 units on scale
Standard Error 1.366
|
|
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53
Change at Week 53: Symptoms Score (n=134, 123)
|
-5.60 units on scale
Standard Error 1.279
|
-6.81 units on scale
Standard Error 1.325
|
SECONDARY outcome
Timeframe: Week 53Population: The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. A 4-point change in total score demonstrates a clinically meaningful change, while an 8-point change and a 12-point change are interpreted as a moderate and large change in health status, respectively.
Outcome measures
| Measure |
Placebo
n=164 Participants
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
n=160 Participants
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
|---|---|---|
|
Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
Week 53: 4-point improvement (n=134,123)
|
45.5 percentage of participants
|
43.1 percentage of participants
|
|
Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
Week 53: 12-point improvement (n=134,123)
|
17.9 percentage of participants
|
17.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 53Population: The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure.
The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).
Outcome measures
| Measure |
Placebo
n=123 Participants
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
n=116 Participants
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
|---|---|---|
|
Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53
|
-0.27 units on a scale
Standard Error 0.107
|
-0.08 units on a scale
Standard Error 0.110
|
SECONDARY outcome
Timeframe: Baseline and Week 53Population: The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure.
The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD). Negative change score signifies improvement compared to baseline. Number of participants with improvement in BODE score compared to baseline were reported.
Outcome measures
| Measure |
Placebo
n=123 Participants
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
n=116 Participants
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
|---|---|---|
|
Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score
|
39.0 percentage of participants
|
33.6 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Week 69Population: Safety population included all participants who were randomized and received at least one dose of investigational product.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was 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. Treatment-emergent are events between administration of study drug and up to Week 69 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.
Outcome measures
| Measure |
Placebo
n=164 Participants
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
n=160 Participants
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
130 participants
|
130 participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
35 participants
|
41 participants
|
SECONDARY outcome
Timeframe: Pre-dose (Baseline), Post-dose on Week 53Population: PK population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum concentration.
Outcome measures
| Measure |
Placebo
n=158 Participants
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
|---|---|---|
|
Observed Serum Concentrations of MEDI8968
Baseline (n=145)
|
1.7 nanogram per milliliters (ng/mL)
Standard Deviation 14.6
|
—
|
|
Observed Serum Concentrations of MEDI8968
Week 53 (n=120)
|
28555.7 nanogram per milliliters (ng/mL)
Standard Deviation 27545.6
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Week 69Population: Immunogenicity (IM) population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum sample for IM testing.
Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis.
Outcome measures
| Measure |
Placebo
n=163 Participants
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 600 mg IV, 300 mg SC
n=157 Participants
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
|
|---|---|---|
|
Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit
|
10 participants
|
19 participants
|
Adverse Events
PLACEBO
MEDI8968 300 mg
Serious adverse events
| Measure |
PLACEBO
n=164 participants at risk
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 300 mg
n=160 participants at risk
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 5.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Cardiac disorders
Adams-stokes syndrome
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Cardiac disorders
Angina pectoris
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Cardiac disorders
Atrial fibrillation
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Cardiac disorders
Cardiac failure
|
1.2%
2/164 • Number of events 2 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 2 • Day 1 up to Week 69
|
|
Cardiac disorders
Cardiac failure chronic
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Cardiac disorders
Coronary artery disease
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
1.2%
2/160 • Number of events 2 • Day 1 up to Week 69
|
|
Cardiac disorders
Myocardial ischaemia
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
1.2%
2/160 • Number of events 2 • Day 1 up to Week 69
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Congenital, familial and genetic disorders
Ebstein's anomaly
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
General disorders
Chest pain
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Infections and infestations
Appendicitis
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Infections and infestations
Atypical mycobacterial pneumonia
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Infections and infestations
Cellulitis
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Infections and infestations
Cholecystitis infective
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Infections and infestations
Erysipelas
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Infections and infestations
Pneumonia
|
2.4%
4/164 • Number of events 4 • Day 1 up to Week 69
|
4.4%
7/160 • Number of events 7 • Day 1 up to Week 69
|
|
Infections and infestations
Pneumonia bacterial
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Infections and infestations
Sepsis
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Infections and infestations
Septic shock
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Injury, poisoning and procedural complications
Fracture
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Investigations
International normalised ratio increased
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Nervous system disorders
Presyncope
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Nervous system disorders
Sciatica
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Nervous system disorders
Syncope
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.4%
4/164 • Number of events 4 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.61%
1/164 • Number of events 1 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
10.4%
17/164 • Number of events 29 • Day 1 up to Week 69
|
11.2%
18/160 • Number of events 21 • Day 1 up to Week 69
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.61%
1/164 • Number of events 2 • Day 1 up to Week 69
|
0.00%
0/160 • Day 1 up to Week 69
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/164 • Day 1 up to Week 69
|
0.62%
1/160 • Number of events 1 • Day 1 up to Week 69
|
Other adverse events
| Measure |
PLACEBO
n=164 participants at risk
Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
|
MEDI8968 300 mg
n=160 participants at risk
MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 5.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
3/164 • Number of events 3 • Day 1 up to Week 69
|
2.5%
4/160 • Number of events 4 • Day 1 up to Week 69
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.4%
4/164 • Number of events 4 • Day 1 up to Week 69
|
1.9%
3/160 • Number of events 3 • Day 1 up to Week 69
|
|
Gastrointestinal disorders
Nausea
|
1.8%
3/164 • Number of events 3 • Day 1 up to Week 69
|
3.1%
5/160 • Number of events 5 • Day 1 up to Week 69
|
|
General disorders
Pyrexia
|
3.7%
6/164 • Number of events 6 • Day 1 up to Week 69
|
5.0%
8/160 • Number of events 13 • Day 1 up to Week 69
|
|
Infections and infestations
Bronchitis
|
2.4%
4/164 • Number of events 4 • Day 1 up to Week 69
|
3.1%
5/160 • Number of events 7 • Day 1 up to Week 69
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
11/164 • Number of events 13 • Day 1 up to Week 69
|
6.9%
11/160 • Number of events 12 • Day 1 up to Week 69
|
|
Infections and infestations
Pneumonia
|
2.4%
4/164 • Number of events 4 • Day 1 up to Week 69
|
1.9%
3/160 • Number of events 3 • Day 1 up to Week 69
|
|
Infections and infestations
Sinusitis
|
3.0%
5/164 • Number of events 6 • Day 1 up to Week 69
|
1.9%
3/160 • Number of events 5 • Day 1 up to Week 69
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
7/164 • Number of events 7 • Day 1 up to Week 69
|
3.1%
5/160 • Number of events 5 • Day 1 up to Week 69
|
|
Infections and infestations
Urinary tract infection
|
3.0%
5/164 • Number of events 7 • Day 1 up to Week 69
|
3.1%
5/160 • Number of events 8 • Day 1 up to Week 69
|
|
Investigations
Weight decreased
|
1.8%
3/164 • Number of events 3 • Day 1 up to Week 69
|
2.5%
4/160 • Number of events 5 • Day 1 up to Week 69
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
2.4%
4/164 • Number of events 5 • Day 1 up to Week 69
|
1.9%
3/160 • Number of events 3 • Day 1 up to Week 69
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.8%
3/164 • Number of events 3 • Day 1 up to Week 69
|
2.5%
4/160 • Number of events 4 • Day 1 up to Week 69
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
2/164 • Number of events 2 • Day 1 up to Week 69
|
3.1%
5/160 • Number of events 5 • Day 1 up to Week 69
|
|
Nervous system disorders
Dizziness
|
2.4%
4/164 • Number of events 4 • Day 1 up to Week 69
|
2.5%
4/160 • Number of events 4 • Day 1 up to Week 69
|
|
Nervous system disorders
Headache
|
4.3%
7/164 • Number of events 27 • Day 1 up to Week 69
|
6.2%
10/160 • Number of events 10 • Day 1 up to Week 69
|
|
Psychiatric disorders
Insomnia
|
3.0%
5/164 • Number of events 5 • Day 1 up to Week 69
|
1.2%
2/160 • Number of events 2 • Day 1 up to Week 69
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
43.3%
71/164 • Number of events 138 • Day 1 up to Week 69
|
40.0%
64/160 • Number of events 112 • Day 1 up to Week 69
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
6/164 • Number of events 8 • Day 1 up to Week 69
|
2.5%
4/160 • Number of events 5 • Day 1 up to Week 69
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.0%
5/164 • Number of events 5 • Day 1 up to Week 69
|
1.2%
2/160 • Number of events 2 • Day 1 up to Week 69
|
|
Vascular disorders
Hypertension
|
4.3%
7/164 • Number of events 10 • Day 1 up to Week 69
|
3.1%
5/160 • Number of events 6 • Day 1 up to Week 69
|
Additional Information
Rene van der Merwe, MBChB/Senior Director, Clinical Development
MedImmune, LLC.
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER