An Open-Label Pilot Study Of VTX2735 In Recurrent Pericarditis

Overview

About this study

This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP).

Cohort A will include up to 30 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 up to 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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 04/28/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Sushil Luis, M.B.B.S., Ph.D.	Open for enrollment	Contact information: Structural Heart Disease Research Coordinators (507) 255-6133

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sushil Luis, M.B.B.S., Ph.D.

Open for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available

Clinical Trials