RecruitingPhase 2

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Zomagen Biosciences Ltd. · NCT06836232

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Key facts

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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:

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

Being studied: VTX2735; VTX2735; VTX2735; VTX2735; VTX2735

Conditions: Recurrent Pericarditis

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.