An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

NCT06836232 · tracked via the Priya Life Science USA tracker

Sponsor

Zomagen Biosciences Ltd.

Phase

Phase 2

Started

2025-01-28

Last updated

2026-09-09

Condition(s) studied

Recurrent Pericarditis

Investigational drug(s) / intervention(s)

VTX2735VTX2735VTX2735VTX2735VTX2735

VTX2735: Dose A, Daily

VTX2735: Dose B, Daily

VTX2735: Dose C, Daily

VTX2735: Dose D, Daily

VTX2735: Dose E, Daily

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (18)

Facility	City	Region	Status
Local Site #840012	Tucson	Arizona	Withdrawn
Local Site #840014	Orange	California	Recruiting
Local Site #840016	Saint Augustine	Florida	Recruiting
Local Site #840008	Chicago	Illinois	Recruiting
Local Site #840002	Park Ridge	Illinois	Withdrawn
Local Site #840011	Owensboro	Kentucky	Withdrawn
Local Site #840010	Boston	Massachusetts	Recruiting
Local Site #840005	Rochester	Minnesota	Recruiting
Local Site #840020	New York	New York	Recruiting
Local Site #840017	Cleveland	Ohio	Recruiting
Local Site #840019	Houston	Texas	Recruiting
Local Site #840001	Houston	Texas	Recruiting
Local Site #840013	Salt Lake City	Utah	Recruiting
Local Site #840022	Burlington	Vermont	Recruiting
Local Site #840018	Charlottesville	Virginia	Recruiting
Local Site #840004	Richmond	Virginia	Recruiting
Local Site #840021	Seattle	Washington	Recruiting
Local Site #840101	Ottawa	Ontario	Recruiting

Other trials for the same condition

CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3) Recruiting

REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients Active, not recruiting

Phase 2/3 Study of Participants With Recurrent Pericarditis Evaluating the Efficacy and Safety of KPL-387 Recruiting

Transition to KPL-387 Monotherapy Dosing & Administration Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06836232 on ClinicalTrials.gov ↗ ← All trials in the USA