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NCT Number: NCT06836232

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

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

Recruiting

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Key information

Conditions

Recurrent Pericarditis Cardiovascular Diseases Heart Diseases Pericarditis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Site #840101, Ottawa, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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.

Treatment and study plan

VTX2735

Drug

Dose A, Daily

Primary outcomes

  1. Safety and tolerability of VTX2735

    Time frame: 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

Secondary outcomes

  1. Effect of VTX2735 on pericardial pain

    Time frame: Day 1 of treatment period to Week 6 of treatment period

    Change from baseline in Numeric Pain Rating Scale (NRS) over time through Week 6

  2. Effect of VTX2735 on inflammation

    Time frame: Day 1 of treatment period to Week 6 of treatment period

    Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP) over time through Week 6

Study contacts

Contact information is provided by the study sponsor or research team.

Ventyx Clinical Trial Contact

CONTACT

[email protected]

888-411-5176 ext. ext 108

Sponsors and collaborators

Lead sponsor

Zomagen Biosciences Ltd.

Industry

Registry information

Official study title

A Phase 2a, Open-Label Pilot Study to Evaluate the Safety/Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VTX2735 in Participants With Recurrent Pericarditis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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