Phase 2
Completed N=324
A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT01448850 ↗Enrolled (actual)
324
Serious AEs
23.5%
Results posted
Jan 2017
Primary outcomePrimary: Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) — 0.78; 0.71 AECOPD events/year — p=0.645
Summary
The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the underlying disease condition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) |
0.78; 0.71 | 0.645 |
| SECONDARY Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) |
0.14; 0.10 | — |
| SECONDARY Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) |
NA; NA | — |
| SECONDARY Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53 |
-2.76; -2.22; -1.15; -1.38; -2.91; -1.08 | — |
| SECONDARY Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score |
45.5; 43.1; 17.9; 17.1 | — |
| SECONDARY Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53 |
-0.27; -0.08 | — |
| SECONDARY Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score |
39.0; 33.6 | — |
| SECONDARY Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
130; 130; 35; 41 | — |
| SECONDARY Observed Serum Concentrations of MEDI8968 |
1.7; 28555.7 | — |
| SECONDARY Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit |
10; 19 | — |
Eligibility Criteria
Inclusion Criteria
- Age 45 through 75 years
- Predicted (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II, III, and IV) at Screening
- History of previous acute exacerbations of chronic obstructive pulmonary disease (AECOPD) 12 months prior to Screening
- Clinically stable and free from an AECOPD for 8 weeks prior to Day 1
- Current smoker or ex-smoker with a tobacco history of more than or equal to (>=) 10 pack-years.
Exclusion Criteria
- Past or present disease or disorder,
- Significant or unstable ischemic heart disease etc
- Known history of allergy or reaction to any component of the investigational manufacturing product (IMP)
- Past or current malignancy within the past 5 years
- Subjects have had a chest x-ray or Computed Tomography (CT) scan suggestive of malignancy or tuberculosis (TB).
- Use of immunosuppressive medication receipt of any biologic agent.
Data sourced from ClinicalTrials.gov (NCT01448850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.