Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease

Mereo BioPharma

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: BCT197; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02700919

MBCT206

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of BCT197 when added on to standard of care in adult subjects with acute respiratory exacerbations of chronic obstructive pulmonary disease requiring hospitalization. Additionally, the study will characterize the pharmacokinetics of BCT197 in adults with COPD. The total duration of the study will be 26 weeks. Subjects will receive study treatment administration over a period of 5 days after randomization. It is expected that approximately 255 subjects will complete the study and follow-up.

Enrollment: 282 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female adults
• Presence of an active exacerbation of the ongoing COPD requiring hospitalization for treatment
• Subjects with a documented diagnosis of COPD C or D
• Current smokers or ex-smokers
• A documented history of at least one moderate or severe COPD exacerbation in the 12 months preceding the Screening Visit that required antibiotics and/or systemic corticosteroid.
• Current regular treatment for COPD (for at least 2 months prior to the Screening Visit.

Exclusion criteria

• Age less than 40 years old
• Current diagnosis of asthma
• Subjects who have already completed treatment for the current exacerbation of COPD
• Subjects currently requiring intensive care unit (ICU) and/or mechanical ventilation
• Received a course of PDE4, p38 or PDE3/4 inhibitors within their respective defined washout periods.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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282 participants in 3 patient groups, including a placebo group

Regimen 1

Experimental group

Description:

Drug: BCT197 Dose 1, Day 1 to Day 5

Treatment:

Drug: BCT197

Regimen 2

Experimental group

Description:

Drug: BCT197 Dose 2, Day 1 to Day 5

Treatment:

Drug: BCT197

Regimen 3

Placebo Comparator group

Description:

Placebo Day 1 to Day 5

Treatment:

Drug: Placebo