Phase 2 N=324 Randomized Triple-blind Treatment

A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease

Bottom Line

View on ClinicalTrials.gov: NCT01448850 ↗

Enrolled (actual)

324

Serious AEs

23.5%

Results posted

Jan 2017

Primary outcome: Primary: Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) — 0.78; 0.71 AECOPD events/year — p=0.645

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: MEDI8968 600 mg IV, 300 mg SC (Biological); Placebo (Other)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: MedImmune LLC
Primary completion: Feb 2014

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.