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This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP).
Cohort A will include approximately 10 participants and will consist of the following:
Cohort B will include approximately 20 participants and will consist of the following:
Cohort C will include approximately 20 participants and will consist of the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental |
| |
| Cohort B Treatment Group B1 | Experimental |
| |
| Cohort B Treatment Group B2 | Experimental |
| |
| Cohort C Treatment Group C1 | Experimental |
| |
| Cohort C Treatment Group C2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VTX2735 | Drug | Dose A, Daily |
| |
| VTX2735 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of VTX2735 | Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation | Day 1 of treatment period through study completion, up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of VTX2735 on pericardial pain | Change from baseline in Numeric Pain Rating Scale (NRS) over time through Week 6 | Day 1 of treatment period to Week 6 of treatment period |
| Effect of VTX2735 on inflammation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ventyx Clinical Trial Contact | Contact | 888-411-5176 | ext 108 | ClinicalTrials@ventyxbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Site #840012 | Withdrawn | Tucson | Arizona | 85718 | United States | |
| Local Site #840014 |
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| Drug |
Dose B, Daily |
|
| VTX2735 | Drug | Dose C, Daily |
|
| VTX2735 | Drug | Dose D, Daily |
|
| VTX2735 | Drug | Dose E, Daily |
|
Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP) over time through Week 6
| Day 1 of treatment period to Week 6 of treatment period |
| Recruiting |
| Orange |
| California |
| 92868 |
| United States |
| Local Site #840016 | Recruiting | Saint Augustine | Florida | 32086 | United States |
| Local Site #840008 | Recruiting | Chicago | Illinois | 60611 | United States |
| Local Site #840002 | Withdrawn | Park Ridge | Illinois | 60068 | United States |
| Local Site #840011 | Withdrawn | Owensboro | Kentucky | 42303 | United States |
| Local Site #840010 | Recruiting | Boston | Massachusetts | 02114 | United States |
| Local Site #840005 | Recruiting | Rochester | Minnesota | 55905 | United States |
| Local Site #840020 | Recruiting | New York | New York | 10032 | United States |
| Local Site #840017 | Recruiting | Cleveland | Ohio | 44195 | United States |
| Local Site #840019 | Recruiting | Houston | Texas | 77030 | United States |
| Local Site #840001 | Recruiting | Houston | Texas | 77034 | United States |
| Local Site #840013 | Recruiting | Salt Lake City | Utah | 84132 | United States |
| Local Site #840022 | Recruiting | Burlington | Vermont | 05401 | United States |
| Local Site #840018 | Recruiting | Charlottesville | Virginia | 22908 | United States |
| Local Site #840004 | Recruiting | Richmond | Virginia | 23219 | United States |
| Local Site #840021 | Recruiting | Seattle | Washington | 98105 | United States |
| Local Site #840101 | Recruiting | Ottawa | Ontario | K1Y 4W7 | Canada |
| ID | Term |
|---|---|
| D010493 | Pericarditis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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