Recurrent Pericarditis
Conditions
Keywords
Ventyx, Zomagen, Recurrent Pericarditis, VTX2735, NLRP3 Inhibitor, NLRP3, Inflammasome
Brief summary
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: * A 30-day Screening Period (to see if a participant qualifies for the study) * A 6-week Open Label Treatment Period - participant receives VTX2735 Dose A * A 7-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose A * An 11-week Once Daily Treatment Period (if a participant meets criteria for this treatment period) - participant receives VTX2735 Dose B * A 14-day Follow-Up Period Cohort B will include approximately 20 participants and will consist of the following: * A 30-day Screening Period (to see if a participant qualifies for the study) * A 6-week Open Label Treatment Period - participant receives VTX2735 Dose B or C * An 18-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose B or C * A 14-day Follow-Up Period Cohort C will include approximately 20 participants and will consist of the following: * A 30-day Screening Period (to see if a participant qualifies for the study) * A 6-week Open Label Treatment Period - participant receives VTX2735 Dose D or E, and B * An 18-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose B * A 14-day Follow-Up Period
Interventions
DRUGVTX2735
Dose A, Daily
Sponsors
Zomagen Biosciences Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants are male or female ≥ 18 years up to ≤ 75 years of age. * Capable of giving signed informed consent and able to comply with the protocol * Previously had an index (first) episode of pericarditis which met the criteria for an acute pericarditis event * Ongoing symptomatic episode of pericarditis, or may have an episode of recurrent pericarditis in the next 4 weeks. * CRP by local laboratory assessment prior to first dose of study treatment (participants with CRP ≤ 10 mg/L must be receiving corticosteroid treatment for RP and have evidence of pericardial inflammation) * Pericarditis pain score ≥ 4 based on the 11-point NRS. * Stable doses of NSAIDs, colchicine, and/or oral corticosteroids (if receiving these treatments)
Exclusion criteria
* Current or prior diagnosis of pericarditis that is secondary to specific prohibited causes, including but not limited to tuberculosis, blunt trauma, tumor, myocarditis, or systemic autoimmune diseases. * History of clinically significant immunosuppressive disorder, autoimmune/autoinflammatory disorder, or primary or secondary immunodeficiency. * Clinically important history of a medical disorder that would compromise safety or data quality, per the Investigator's judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of VTX2735 | Day 1 of treatment period through study completion, up to 26 weeks | Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of VTX2735 on pericardial pain | Day 1 of treatment period to Week 6 of treatment period | Change from baseline in Numeric Pain Rating Scale (NRS) over time through Week 6 |
| Effect of VTX2735 on inflammation | Day 1 of treatment period to Week 6 of treatment period | Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP) over time through Week 6 |
Countries
Canada, United States
Contacts
CONTACTVentyx Clinical Trial Contact
Outcome results
None listed