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
Qualifiers
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
Treatments tested in this trial
- VTX2735
- VTX2735
- VTX2735
- VTX2735
- VTX2735
Treatment groups
50 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov