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

NCT02700919 | Completed Phase 2 Results DMC

• 1 other identifier: MBCT206
• Study Type: interventional
• Target: 282
• Locations: 10 countries
• Sites: 46

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in FEV1 to Day 7 - ITT Population

  FEV1 data were recorded daily from Days 1 to 7 of the study using a computer-operated spirometer. Analysis was based on a linear Mixed Model for Repeated Measures (MMRM) with Change from Baseline in parameter as outcome; including treatment, visit, treatment by visit interaction, severity of airflow limitation at Baseline, blood eosinophils (%) at Baseline, time from start of current chronic obstructive pulmonary disease (COPD) exacerbation to first study treatment dosing, presence of cardiovascular comorbidities at Screening and COPD exacerbation treatment at Screening as fixed effects, and Baseline value and Baseline by visit interaction as covariates. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments. Results were presented with adjusted mean (95% confidence interval).

  Days 1 to 7

Secondary Outcomes (16)

• Change From Baseline in FEV1 on Days 3, 10, and 14 - ITT Population

  Days 3, 10, and 14

• Normalization Evaluation of FEV1 Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population

  Baseline, Days 1 to 7, Days 10 and 14, Week 8, Week 12 and Week 26

• Normalization Evaluation of FEV1/FVC Over Time (Days 1 to 7, Days 10 and 14, and Weeks 8, 12 and 26) Compared With the Most Recent Test Performed Within the Last 12 Months Outside an Exacerbation - ITT Population

  Baseline to Week 26

• Time to Improvement of 100 mL in FEV1 Over Time - ITT Population

  Baseline to Week 26

• Area Under the Curve (AUC) of FEV1 Over Time - ITT Population

  Day 1 to Day 14

Other Outcomes (1)

• Pharmacokinetic (PK) of BCT197 in Adults With COPD - PK Population

  Days 1 to 5

Study Arms (3)

Regimen 1

EXPERIMENTAL

Drug: BCT197 Dose 1, Day 1 to Day 5

Drug: BCT197

Regimen 2

EXPERIMENTAL

Drug: BCT197 Dose 2, Day 1 to Day 5

Drug: BCT197

Regimen 3

PLACEBO COMPARATOR

Placebo Day 1 to Day 5

Drug: Placebo

Interventions

BCT197 DRUG

Capsules will be taken orally with fluids over a 5 day period after randomization

Regimen 1; Regimen 2

Placebo DRUG

Capsules will be taken orally with fluids over a 5 day period after randomization

Regimen 3

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mereo BioPharma: lead

Study Sites (46)

Mereo Research Site

Michigan City, Indiana, United States

Location

Mereo Research Site

Baltimore, Maryland, United States

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Mereo Research Site

Milwaukee, Wisconsin, United States

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Mereo Research Site

Dupnitsa, Bulgaria

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Mereo Research Site

Gabrovo, Bulgaria

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Mereo Research Site

Kardzhali, Bulgaria

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Mereo Research Site

Kozloduy, Bulgaria

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Mereo Research Site

Kyustendil, Bulgaria

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Mereo Research Site

Lovech, Bulgaria

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Mereo Research Site

Montana, Bulgaria

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Mereo Research Site

Razgrad, Bulgaria

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Mereo Research Site

Rousse, Bulgaria

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Mereo Research Site

Shumen, Bulgaria

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Mereo Research Site

Sliven, Bulgaria

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Mereo Research Site

Sofia, Bulgaria

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Mereo Research Site

Kyjov, Czechia

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Mereo Research Site

Mělník, Czechia

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Mereo Research Site

Slaný, Czechia

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Mereo Research Site

Dresden, Germany

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Mereo Research Site

Balassagyarmat, Hungary

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Mereo Research Site

Budapest, Hungary

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Mereo Research Site

Debrecen, Hungary

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Mereo Research Site

Farkasgyepű, Hungary

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Mereo Research Site

Miskolc, Hungary

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Mereo Research Site

Mohács, Hungary

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Mereo Research Site

Naples, Italy

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Mereo Research Site

Daugavpils, Latvia

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Mereo Research Site

Riga, Latvia

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Mereo Research Site

Valmiera, Latvia

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Mereo Research Site

Chrzanów, Poland

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Mereo Research Site

Krakow, Poland

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Mereo Research Site

Proszowice, Poland

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Mereo Research Site

Wroclaw, Poland

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Mereo Research Site

Zgierz, Poland

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Mereo Research Site

Bucharest, Romania

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Mereo Research Site

Cluj-Napoca, Romania

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Mereo Research Site

Constanța, Romania

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Mereo Research Site

Craiova, Romania

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Mereo Research Site

Marghita, Romania

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Mereo Research Site

Suceava, Romania

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Mereo Research Site

Timișoara, Romania

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Mereo Research Site

Izhevsk, Russia

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Mereo Research Site

Kemerovo, Russia

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Mereo Research Site

Saint Petersburg, Russia

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Mereo Research Site

Saratov, Russia

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Mereo Research Site

Tomsk, Russia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ian Hodgson, Head of Clinical Operations
• Organization: Mereo BioPharma Group

enquiries@mereobiopharma.com

+44 3330237300

Study Officials

• Jacqueline Parkin, PhD FRCP

  Mereo BioPharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 7, 2016
• Study Start: August 1, 2016
• Primary Completion: November 8, 2017
• Study Completion: November 28, 2017
• Last Updated: November 30, 2020
• Results First Posted: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5); LA (3); HU (6); US (3); BU (12); CZ (3); DE (1); IT (1); RO (7); RU (5)