Clinical trial NCT06836232: An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Recurrent Pericarditis
Keywords: Ventyx
Zomagen
Recurrent Pericarditis
VTX2735
NLRP3 Inhibitor
NLRP3
Inflammasome
Lead sponsor: Zomagen Biosciences Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP). Approximately 30 patients will take VTX2735.

The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 6-week Open Label Treatment period (a participant receives active Dose A), a 7-week Extension Treatment period (a participant meets criteria for continuing and receives active Dose A) and a 14-day Follow-Up Period.


Eligibility criteria: 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 ≤ 1 mg/dL 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 outcomes:
measure: Safety and tolerability of VTX2735
timeFrame: Day 1 of treatment period through study completion, up to 15 weeks
Secondary outcomes:
measure: Effect of VTX2735 on pericardial pain
timeFrame: Day 1 of treatment period to Week 6 of treatment period
measure: Effect of VTX2735 on inflammation
timeFrame: Day 1 of treatment period to Week 6 of treatment period
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Site #840012
state: Arizona
city: St. Augustine
country: United States
facility: Local Site #840016
state: Florida
city: Chicago
country: United States
facility: Local Site #840008
state: Illinois
city: Park Ridge
country: United States
facility: Local Site #840002
state: Illinois
city: Owensboro
country: United States
facility: Local Site #840011
state: Kentucky
city: Rochester
country: United States
facility: Local Site #840005
state: Minnesota
city: Houston
country: United States
facility: Local Site #840001
state: Texas
city: Richmond
country: United States
facility: Local Site #840004
state: Virginia
Study officials:
affiliation: Ventyx Biosciences
name: Henrik Sonnergren, MD, PhD
role: STUDY_DIRECTOR
References: