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

MedImmune

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Biological: MEDI8968 600 mg IV, 300 mg SC; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01448850

CD-RI-MEDI8968-1103

Details and patient eligibility

About

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.

Full description

A Phase 2 double-blind, placebo-controlled study to evaluate the efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease. The study will have a screening phase of 23 days, treatment phase from Week 1 to 53 and follow-up phase from Week 53 to 69. Participants will receive either MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53 or matching placebo in the same fashion. Participants will primarily be assessed for incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Safety will be monitored throughout the study.

Enrollment: 464 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

464 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.

Treatment:

Other: Placebo

MEDI8968 600 mg IV, 300 mg SC

Experimental group

Description:

MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53.

Treatment:

Biological: MEDI8968 600 mg IV, 300 mg SC