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Clinical Trials in Canada / NCT06836232
Recruiting Phase 2

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

NCT06836232 · tracked via the Priya Life Science Canada tracker
Sponsor
Zomagen Biosciences Ltd
Phase
Phase 2
Started
2025-01-28
Last updated
2026-10-09

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
No
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 (20)

FacilityCityRegionStatus
Site Location #840023 La Jolla California Recruiting
Local Site #840014 Orange California Recruiting
Local Site #840016 Saint Augustine Florida Recruiting
Local Site #840008 Chicago Illinois Recruiting
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 #840004 Richmond Virginia Recruiting
Local Site #840018 Richmond Virginia Recruiting
Local Site #840021 Seattle Washington Recruiting
Local Site #056001 Ghent Belgium Recruiting
Local Site #056002 Leuven Belgium Recruiting
Local Site #840102 Montreal Canada Not Yet Recruiting
Local Site #840101 Ottawa Canada Recruiting
Local Site #300001 Athens Greece Not Yet Recruiting

Other trials for the same condition

Phase 2/3 Study of Participants With Recurrent Pericarditis Evaluating the Efficacy and Safety of KPL-387 Recruiting
CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3) 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 Canada