Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
FORTITUDE-HCM is a global, multicenter, double-blind, parallel-group, placebo-controlled Phase 2b study that will assess the efficacy and safety of ninerafaxstat compared to placebo on top of Standard of Care in patients with symptomatic nHCM
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ninerafaxstat | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ninerafaxstat 200mg MR | Drug | Ninerafaxstat 200mg Modified Release tablet administered BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) | The Clinical Summary Score is a merging of symptom frequency and symptom burden domains into a total symptom score combined with the physical limitation domain. Scoring ranges from 0 to 100, with higher scores indicating better health status. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ventilatory efficiency (VE/VCO2 slope) during cardiopulmonary exercise testing (CPET) | Baseline to Week 12 | |
| Change in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) | The Total Symptom Score is a merging of symptom frequency and symptom burden domains. Scoring ranges from 0 to 100, with higher scores indicating better health status. |
Not provided
Select Inclusion Criteria:
Select Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Contact | (617) 675-4060 | info@imbria.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imbria Investigational Site | Recruiting | La Jolla | California | 92037 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Matching placebo tablet administered BID |
|
| Baseline to Week 12 |
| Change in the Kansas City Cardiomyopathy Questionnaire Physical Limitations Score (KCCQ-PLS) | The Physical Limitations Score is a single-domain score. Scoring ranges from 0 to 100, with higher scores indicating better health status. | Baseline to Week 12 |
| Change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) | The Overall Summary Score is a merging of symptom, physical limitations, social limitations, and quality of life domains. Scoring ranges from 0 to 100, with higher scores indicating better health status. | Baseline to Week 12 |
| Imbria Investigational Site | Recruiting | Los Angeles | California | 90048 | United States |
|
| Imbria Investigational Site | Recruiting | San Francisco | California | 94143 | United States |
|
| Imbria Investigational Site | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| Imbria Investigational Site | Recruiting | Miami | Florida | 33136 | United States |
|
| Imbria Investigational Site | Recruiting | Chicago | Illinois | 60611 | United States |
|
| Imbria Investigational Site | Not yet recruiting | Oak Lawn | Illinois | 60453 | United States |
|
| Imbria Investigational Site | Recruiting | Baltimore | Maryland | 21218 | United States |
|
| Imbria Investigational Site | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Imbria Investigational Site | Recruiting | Burlington | Massachusetts | 01805 | United States |
|
| Imbria Investigational Site | Recruiting | Grand Rapids | Michigan | 49503 | United States |
|
| Imbria Investigational Site | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Imbria Investigational Site | Recruiting | St Louis | Missouri | 63110 | United States |
|
| Imbria Investigational Site | Recruiting | New York | New York | 10016 | United States |
|
| Imbria Investigational Site | Recruiting | Charlotte | North Carolina | 28204 | United States |
|
| Imbria Investigational Site | Recruiting | Portland | Oregon | 97239 | United States |
|
| Imbria Investigational Site | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Imbria Investigational Site | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| Imbria Investigational Site | Recruiting | Houston | Texas | 77030 | United States |
|
| Imbria Investigational Site | Recruiting | Plano | Texas | 75093 | United States |
|
| Imbria Investigational Site | Recruiting | Charlottesville | Virginia | 22903 | United States |
|
| Imbria Investigational Site | Recruiting | Richmond | Virginia | 23298 | United States |
|
| Imbria Investigational Site | Recruiting | Graz | 8036 | Austria |
|
| Imbria Investigational Site | Recruiting | Edegem | 2650 | Belgium |
|
| Imbria Investigational Site | Recruiting | Montpellier | 34295 | France |
|
| Imbria Investigational Site | Recruiting | Paris | 75015 | France |
|
| Imbria Investigational Site | Recruiting | Saint-Herblain | 44800 | France |
|
| Imbria Investigational Site | Recruiting | Bad Oeynhausen | 32545 | Germany |
|
| Imbria Investigational Site | Recruiting | Göttingen | 37075 | Germany |
|
| Imbria Investigational Site | Recruiting | Heidelberg | 69120 | Germany |
|
| Imbria Investigational Site | Not yet recruiting | Jena | 07747 | Germany |
|
| Imbria Investigational Site | Recruiting | Florence | 50139 | Italy |
|
| Imbria Investigational Site | Recruiting | Massa | 54100 | Italy |
|
| Imbria Investigational Site | Recruiting | Milan | 20131 | Italy |
|
| Imbria Investigational Site | Recruiting | Milan | 20146 | Italy |
|
| Imbria Investigational Site | Recruiting | Milan | 20162 | Italy |
|
| Imbria Investigational Site | Recruiting | Naples | 80131 | Italy |
|
| Imbria Investigational Site | Recruiting | Amsterdam-Zuidoost | 1105 AZ | Netherlands |
|
| Imbria Investigational Site | Not yet recruiting | Leiden | 2333ZC | Netherlands |
|
| Imbria Investigational Site | Not yet recruiting | Nijmegen | 6525 GA | Netherlands |
|
| Imbria Investigational Site | Recruiting | Rotterdam | 3015 AA | Netherlands |
|
| Imbria Investigational Site | Recruiting | Katowice | 40-555 | Poland |
|
| Imbria Investigational Site | Recruiting | Warsaw | 02-507 | Poland |
|
| Imbria Investigational Site | Recruiting | Wroclaw | 53-114 | Poland |
|
| Imbria Investigational Site | Recruiting | Guimarães | 4835-044 | Portugal |
|
| Imbria Investigational Site | Recruiting | Lisbon | 1169-024 | Portugal |
|
| Imbria Investigational Site | Recruiting | Lisbon | 1500-650 | Portugal |
|
| Imbria Investigational Site | Recruiting | Barcelona | Barcelona | 08035 | Spain |
|
| Imbria Investigational Site | Recruiting | A Coruña | Galicia | 15006 | Spain |
|
| Imbria Investigational Site | Recruiting | Madrid | Madrid | 28034 | Spain |
|
| Imbria Investigational Site | Recruiting | Vigo | Pontevedra | 36312 | Spain |
|
| Imbria Investigational Site | Recruiting | Seville | Sevilla | 41009 | Spain |
|
| Imbria Investigational Site | Recruiting | Seville | Sevilla | 41013 | Spain |
|
| Imbria Investigational Site | Recruiting | Barcelona | 8036 | Spain |
|
| Imbria Investigational Site | Recruiting | Barcelona | 8041 | Spain |
|
| Imbria Investigational Site | Recruiting | Barcelona | 8907 | Spain |
|
| Imbria Investigational Site | Recruiting | El Palmar | 30120 | Spain |
|
| Imbria Investigational Site | Recruiting | Madrid | 28222 | Spain |
|
| Imbria Investigational Site | Recruiting | Palma de Mallorca | 07198 | Spain |
|
| Imbria Investigational Site | Recruiting | Salamanca | 37007 | Spain |
|
| Imbria Investigational Site | Recruiting | Valencia | 03010 | Spain |
|
| Imbria Investigational Site | Recruiting | Valencia | 46026 | Spain |
|
| Imbria Investigational Site | Recruiting | London | England | W12 0HS | United Kingdom |
|
| Imbria Investigational Site | Recruiting | Glasgow | Scotland | G51 4TF | United Kingdom |
|
| Imbria Investigational Site | Recruiting | London | EC1A 7BE | United Kingdom |
|
| Imbria Investigational Site | Recruiting | London | SW3 6HP | United Kingdom |
|
| Imbria Investigational Site | Recruiting | Oxford | OX3 9DU | United Kingdom |
|
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
Not provided
Not provided