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NCT02700919 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease
A Phase 2 study of Pulmonary Disease, Chronic Obstructive, sponsored by Mereo BioPharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 282
- Enrollment target
- 20
- Study locations
NCT02700919: Completed Phase 2 study of Pulmonary Disease, Chronic Obstructive, sponsored by Mereo BioPharma.
NCT02700919 is a Phase 2 study of Pulmonary Disease, Chronic Obstructive that has completed, run by Mereo BioPharma. The registered enrollment target is 282 participants, below the 1,040-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02700919, a Phase 2 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by Mereo BioPharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 282 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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 cardiovasc
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BCT197
Study Locations (20)
Other
- Mereo Research Site - Dupnitsa
- Mereo Research Site - Gabrovo
- Mereo Research Site - Kardzhali
- Mereo Research Site - Kozloduy
- Mereo Research Site - Kyustendil
- Mereo Research Site - Lovech
- Mereo Research Site - Montana
- Mereo Research Site - Razgrad
- Mereo Research Site - Rousse
- Mereo Research Site - Shumen
- Mereo Research Site - Sliven
- Mereo Research Site - Sofia
- Mereo Research Site - Kyjov
- Mereo Research Site - Mělník
- Mereo Research Site - Slaný
- Mereo Research Site - Dresden
- Mereo Research Site - Balassagyarmat
Indiana
- Mereo Research Site - Michigan City
Maryland
- Mereo Research Site - Baltimore
Wisconsin
- Mereo Research Site - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2016-08-01 |
| Est. Completion | 2017-11-28 |
| Phase | Phase 2 |
What the finished NCT02700919 record still lists
NCT02700919 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, below the 1,040-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02700919 names 20 study sites across 4 states, led by Other, Indiana, Maryland.
Frequently Asked Questions
What is clinical trial NCT02700919 about?
NCT02700919 is a clinical study titled "Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease". 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 BCT...
What is the current status of trial NCT02700919?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 282 participants. The study started on 2016-08-01. Estimated completion is 2017-11-28.
What conditions does trial NCT02700919 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT02700919?
The interventions under investigation include: Placebo (DRUG), BCT197 (DRUG).
Who is sponsoring clinical trial NCT02700919?
This trial is sponsored by Mereo BioPharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02700919 being conducted?
This trial has 20 study locations across Indiana, Maryland, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02700919's enrollment target sits among peer trials
282 39th of 74 higher than 36 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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