Safety & Efficacy of BCT197A2201 in COPD Patients Presenting With an Exacerbation

Mereo BioPharma

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Prednisone; Drug: Prednisone placebo; Drug: BCT197 placebo; Drug: BCT197

Study type: Interventional

Funder types: Industry

Identifiers

NCT01332097

2010-021723-27 (EudraCT Number)

CBCT197A2201

Details and patient eligibility

About

This study will assess preliminary parameters of safety and efficacy of a single dose of BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.

Full description

This was an exploratory, double-blind, randomized, placebo-controlled, multicenter, adaptive parallel-group design study in four parts in patients with acute COPD exacerbation. In Part I, patients were randomized to receive either a single dose of 75mg BCT197, placebo or 40 mg oral prednisone in the ratio of 1:1:1. In Part II patients were randomized to receive either a single dose of 20 mg BCT197 or placebo in the ratio of 5:1. Patients in Parts I and II received their single dose on Day 1 of the study. In Parts III and IV patients were randomized to receive either BCT197 or placebo in a ratio of 5:1 at a dose of 20mg (Part III) or 75 mg (Part IV) with patients receiving a single dose on both Day 1 and Day 6 of the study.

Enrollment: 183 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with COPD (Stage II to IV) with a COPD exacerbation.
• Smoking history of 10 pack years.
• Females must not be of child-bearing potential.

Exclusion criteria

• Use of steroids in the last 30 days or calcium channel blockers in the last 48 hours.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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183 participants in 6 patient groups, including a placebo group

Treatment A

Experimental group

Description:

Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules

Treatment:

Drug: BCT197

Drug: Prednisone placebo

Treatment B/G/E/I

Placebo Comparator group

Description:

Matching placebo comparator arm

Treatment:

Drug: BCT197 placebo

Drug: Prednisone placebo

Treatment C

Active Comparator group

Description:

Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules

Treatment:

Drug: BCT197 placebo

Drug: Prednisone

Treatment D

Experimental group

Description:

Single oral dose of 20mg dose of BCT197 capsules

Treatment:

Drug: BCT197

Treatment F

Experimental group

Description:

Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6

Treatment:

Drug: BCT197

Treatment H

Experimental group

Description:

Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6

Treatment:

Drug: BCT197