Long-Term Study of the Effects of Navarixin (SCH 527123, MK-7123) in Participants With Moderate to Severe COPD (MK-7123-019)

NCT ID: NCT01006616

Last Updated: 2019-01-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 616 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-01
• Study Completion Date: 2011-11-01

Brief Summary

Neutrophils are thought to play an important role in the pathophysiology of chronic obstructive pulmonary disease (COPD). Navarixin (SCH 527123, MK-7123) is an antagonist of the cysteine-X-cysteine chemokine receptor 2 (CXCR2) and is thought to reduce neutrophil migration to the diseased lung. It is theorized that reducing neutrophil migration to the diseased lung will improve a participant's symptoms and the natural history of the disease.

The study will consist of a 2-week screening period followed by a 2-year (104-week) double-blind treatment period. The 2-year Treatment Period will be made up of two phases: a 26-week (6-month) dose range-finding phase with 3 active arms and 1 placebo arm (Period 1), followed by a 78-week (18-month) long-term safety and efficacy phase (Period 2). Participants participating in the original 6-month study (Period 1) may elect not to continue into the 18-month extension study (Period 2).

Hypothesis: navarixin, 50 mg, or the highest remaining dose if the 50-mg dose is discontinued, is superior to placebo with respect to improving airflow.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Navarixin 10 mg

Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally once daily (QD) for up to 2 years

Group Type: EXPERIMENTAL

Navarixin

Intervention Type: DRUG

Navarixin 10 mg and 30 mg capsules

Placebo

Intervention Type: DRUG

Placebo to navarixin capsules

Rescue medication

Intervention Type: DRUG

Short-acting β-agonist (SABA), anticholinergic, or a combination SABA/anticholinergic

Navarixin 30 mg

Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years

Group Type: EXPERIMENTAL

Navarixin

Intervention Type: DRUG

Navarixin 10 mg and 30 mg capsules

Placebo

Intervention Type: DRUG

Placebo to navarixin capsules

Rescue medication

Intervention Type: DRUG

Short-acting β-agonist (SABA), anticholinergic, or a combination SABA/anticholinergic

Navarixin 50 mg

Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years

Group Type: EXPERIMENTAL

Navarixin

Intervention Type: DRUG

Navarixin 10 mg and 30 mg capsules

Rescue medication

Intervention Type: DRUG

Short-acting β-agonist (SABA), anticholinergic, or a combination SABA/anticholinergic

Placebo

Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to navarixin capsules

Rescue medication

Intervention Type: DRUG

Short-acting β-agonist (SABA), anticholinergic, or a combination SABA/anticholinergic

Interventions

Navarixin

Navarixin 10 mg and 30 mg capsules

Intervention Type: DRUG

Placebo

Placebo to navarixin capsules

Intervention Type: DRUG

Rescue medication

Short-acting β-agonist (SABA), anticholinergic, or a combination SABA/anticholinergic

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of COPD for at least 2 years based on American Thoracic Society/European Respiratory Society (ATS/ERS) current guidelines or symptoms consistent with COPD for at least 2 years.
• >40 to <=75 years of age, of either sex, and of any race.
• No exacerbation or respiratory infection in the past 6 weeks.
• Smoker or ex-smoker with more than 10 pack-year history.

Exclusion Criteria

• Diagnosis of asthma or other clinically relevant lung disease (other than COPD), i.e., sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis, or lung cancer.
• Significant X-ray findings.
• Use of supplemental oxygen for >12 hours/day.

• Minimum Eligible Age: 41 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Rennard SI, Dale DC, Donohue JF, Kanniess F, Magnussen H, Sutherland ER, Watz H, Lu S, Stryszak P, Rosenberg E, Staudinger H. CXCR2 Antagonist MK-7123. A Phase 2 Proof-of-Concept Trial for Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 May 1;191(9):1001-11. doi: 10.1164/rccm.201405-0992OC.

Reference Type: RESULT

PMID: 25695403 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2008-003780-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P05575

Identifier Type: OTHER

Identifier Source: secondary_id

P05575

Identifier Type: -

Identifier Source: org_study_id