An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

a study on Pericarditis

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Orange, California and other locations
Dates
study started
study ends around
Principal Investigator
by Amin Sabet

Description

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

Official Title

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

Keywords

Recurrent Pericarditis, Ventyx, Zomagen, VTX2735, NLRP3 Inhibitor, NLRP3, Inflammasome, Pericarditis

Eligibility

You can join if…

Open to people ages 18-75

  • 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)

You CAN'T join if...

  • 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.

Locations

  • University of California Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • UC San Diego Health not yet accepting patients
    La Jolla California 92037 United States
  • University of Utah accepting new patients
    Salt Lake City Utah 84132 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Zomagen Biosciences Ltd.
ID
NCT06836232
Phase
Phase 2 Pericarditis Research Study
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated
Contact us about this trial