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 UC Irvine UCSD
Dates
study started
study ends around
Principal Investigator
by Ajit Raisinghani (ucsd)Amin Sabet (uci)

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

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

Lead Scientists at University of California Health

  • Ajit Raisinghani (ucsd)
    Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 38 research publications
  • Amin Sabet (uci)
    Assistant Health Sciences Professor, Medicine, School of Medicine

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