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

An Exploratory, Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of a Single and a Repeated Dose of Oral BCT197 in Patients With an Acute COPD Exacerbation

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: BCT197; Drug: Prednisone placebo; Drug: BCT197 placebo; Drug: Prednisone

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Novartis Investigative Site
  • Russe, Bulgaria, 7002
    • Novartis Investigative Site
• Romania
  • Bucuresti, Romania, 50159
    • Novartis Investigative Site
• Russian Federation
  • Moscow, Russian Federation, 117292
    • Novartis Investigative Site
  • Moscow, Russian Federation, 107014
    • Novartis Investigative Site
  • St. Petersburg, Russian Federation, 191015
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules	Drug: BCT197; Drug: Prednisone placebo; capsules
Placebo Comparator: Treatment B/G/E/I; Matching placebo comparator arm	Drug: Prednisone placebo; capsules; Drug: BCT197 placebo; capsules
Active Comparator: Treatment C; Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules	Drug: BCT197 placebo; capsules; Drug: Prednisone; capsules
Experimental: Treatment D; Single oral dose of 20mg dose of BCT197 capsules	Drug: BCT197
Experimental: Treatment F; Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6	Drug: BCT197
Experimental: Treatment H; Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6	Drug: BCT197

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second	Change in FEV1 from baseline to Day 5 or baseline to Day 10 measured in mL Measure: FEV1 Change in Forced Expiry Volume in 1 second	Day 5, Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO	EXAcerbations of Chronic pulmonary disease tool patient reported outcome (EXACT-PRO) Rolling Average Improvement from Day 1 to Day 29. EXACT-PRO is a 14 point patient reported daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Minimum score is 0 and Maximum score is 14 (higher scores indicate worsening indicative of an exacerbation). Reported value is LS mean improvement from at Day 29 compared to D1 of the study.	Up to Day 29

Collaborators and Investigators

• Sponsor: Mereo BioPharma
• Collaborators: Novartis

Publications and helpful links

General Publications

• Strambu IR, Kobalava ZD, Magnusson BP, MacKinnon A, Parkin JM. Phase II Study of Single/Repeated Doses of Acumapimod (BCT197) to Treat Acute Exacerbations of COPD. COPD. 2019 Dec;16(5-6):344-353. doi: 10.1080/15412555.2019.1682535. Epub 2019 Nov 4.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: April 7, 2011
• First Submitted That Met QC Criteria: April 7, 2011
• First Posted (Estimate): April 8, 2011

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Exacerbation; Pulmonary Inflammation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: CBCT197A2201; 2010-021723-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No