An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis
ConditionRecurrent Pericarditis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZomagen Biosciences Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
VTX2735
DrugDose A, Daily
VTX2735
DrugDose B, Daily
VTX2735
DrugDose C, Daily
VTX2735
DrugDose D, Daily
VTX2735
DrugDose E, Daily
Treatment groups
50 Participants
are divided into 5 treatment groupsGroup A: Cohort AExperimental treatment 1 intervention
Group B: Cohort B Treatment Group B1Experimental treatment 1 intervention
Group C: Cohort B Treatment Group B2Experimental treatment 1 intervention
Group D: Cohort C Treatment Group C1Experimental treatment 1 intervention
Group E: Cohort C Treatment Group C2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability of VTX2735
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation
Time frame
Day 1 of treatment period through study completion, up to 26 weeksSecondary outcomes
1
Effect of VTX2735 on pericardial pain
Change from baseline in Numeric Pain Rating Scale (NRS) over time through Week 6
Time frame
Day 1 of treatment period to Week 6 of treatment period2
Effect of VTX2735 on inflammation
Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP) over time through Week 6
Time frame
Day 1 of treatment period to Week 6 of treatment periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov