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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021723-27 | EudraCT Number |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules |
|
| Treatment B/G/E/I | Placebo Comparator | Matching placebo comparator arm |
|
| Treatment C | Active Comparator | Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules |
|
| Treatment D | Experimental | Single oral dose of 20mg dose of BCT197 capsules |
|
| Treatment F | Experimental | Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6 |
|
| Treatment H | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCT197 | Drug |
| ||
| Prednisone placebo |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Parkin, PhD FRCP | Mereo BioPharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Plovdiv | 4000 | Bulgaria | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31682162 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A | Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules BCT197 Prednisone placebo: capsules |
| FG001 | Treatment C | Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules Prednisone placebo: capsules BCT197 placebo: capsules |
| FG002 | Treatment D | Single oral dose of 20mg dose of BCT197 capsules BCT197 |
| FG003 | Treatment F | Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6 BCT197 |
| FG004 | Treatment H | Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6 BCT197 |
| FG005 | Treatment B,E,G I | Matching placebo group Treatment B - Single oral dose of BCT placebo Treatment E - Single oral dose of BCT197 placebo and prednisone placebo Treatment G - Single oral dose of BCT197 placebo and Treatment I - Single oral dose of BCT197 placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A | Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules BCT197 Prednisone placebo: capsules |
| BG001 | Treatment B, E,G & I | Matched placebo arms BCT197 placebo: capsules Prednisone placebo: capsules |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The PD analysis set included all participants without major protocol deviations that impacted efficacy/pharmacodynamic data. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and "Number analyzed" is the number of participants evaluated at each time point. | Posted | Least Squares Mean | 95% Confidence Interval | mL | Day 5, Day 10 |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules BCT197 Prednisone placebo: capsules |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jackie Parkin | Mereo BioPharma | +44 333 0237300 | enquiries@mereobiopharma.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6
|
| Drug |
capsules |
|
| BCT197 placebo | Drug | capsules |
|
| Prednisone | Drug | capsules |
|
| Up to Day 29 |
| Rousse |
| 7002 |
| Bulgaria |
| Novartis Investigative Site | Bucharest | 50159 | Romania |
| Novartis Investigative Site | Moscow | 107014 | Russia |
| Novartis Investigative Site | Moscow | 117292 | Russia |
| Novartis Investigative Site | Saint Petersburg | 191015 | Russia |
| BG002 | Treatment C | Single oral dose of BCT197 placebo capsules + single oral dose of 40mg prednisone capsules Prednisone: capsules BCT197 placebo: capsules |
| BG003 | Treatment D | Single oral dose of 20mg dose of BCT197 capsules BCT197 |
| BG004 | Treatment F | Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6 BCT197 |
| BG005 | Treatment H | Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6 BCT197 |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Treatment B, E, G & I |
Matched Placebo arms BCT197 placebo: capsules Prednisone placebo: capsules |
| OG002 | Treatment C | Single oral dose of BCT197 placebo capsules + single oral dose of 40mg prednisone capsules Prednisone BCT197 placebo: capsules |
| OG003 | Treatment D | Single oral dose of 20mg dose of BCT197 capsules BCT197 |
| OG004 | Treatment F | Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6 BCT197 |
| OG005 | Treatment H | Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6 BCT197 |
|
|
|
| Secondary | 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. | The PD analysis set included all participants without major protocol deviations that impacted efficacy/pharmacodynamic data. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Up to Day 29 |
|
|
|
| 1 |
| 31 |
| 2 |
| 31 |
| 5 |
| 31 |
| EG001 | Treatment B, E, G & I | Matching placebo Single oral dose of BCT197 placebo capsules + single oral dose of prednisone placebo capsules Prednisone placebo: capsules BCT197 placebo: capsules | 0 | 45 | 4 | 45 | 20 | 45 |
| EG002 | Treatment C | Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules Prednisone placebo: capsules BCT197 placebo: capsules | 2 | 30 | 5 | 30 | 16 | 30 |
| EG003 | Treatment D | Single oral dose of 20mg dose of BCT197 capsules BCT197 | 1 | 25 | 2 | 25 | 13 | 25 |
| EG004 | Treatment F | Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6 BCT197 | 1 | 27 | 3 | 27 | 14 | 27 |
| EG005 | Treatment H | Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6 BCT197 | 1 | 25 | 3 | 25 | 16 | 25 |
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | COPD Exacerbation |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Cardiac Failure Acute | Cardiac disorders | Systematic Assessment | Acute cardiac failure |
|
| Cerebral Edema | Nervous system disorders | Systematic Assessment | Brain odema |
|
| Decompensated Chronic Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Chronic respiratory failure |
|
| Attrial Flutter | Cardiac disorders | Systematic Assessment | Attrial Flutter |
|
| Sudden cardiac death | General disorders | Systematic Assessment | Sudden cardiac death |
|
| Stoke | Nervous system disorders | Systematic Assessment | Cerebrovascular accident |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Occult blood | Investigations | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
All PIs must seek written permission from the sponsor before publication of any trial results.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
|