Testing VTX2735 for treating recurrent pericarditis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of VTX2735 in patients diagnosed with recurrent pericarditis. Approximately 30 participants will undergo a 30-day screening period followed by a 6-week open-label treatment phase where they will receive the active drug. If they meet specific criteria, they may continue treatment for an additional 7 weeks, followed by a 14-day follow-up period. The study aims to assess the impact of VTX2735 on symptoms and inflammation associated with recurrent pericarditis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Site Location #840023
  La Jolla, California, United States Recruiting
• Local Site #840014
  Orange, California, United States Recruiting
• Local Site #840016
  Saint Augustine, Florida, United States Recruiting
• Local Site #840008
  Chicago, Illinois, United States Recruiting
• Local Site #840010
  Boston, Massachusetts, United States Recruiting
• Local Site #840005
  Rochester, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Ventyx Clinical Trial Contact
• Email: ClinicalTrials@ventyxbio.com
• Phone: 888-411-5176

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transitioning people with recurrent pericarditis to KPL-387 monotherapy dosing and administration

  This trial will try switching people with well-controlled recurrent pericarditis from their current therapies to KPL-387 alone for up to 16 weeks to see if symptoms and inflammation stay controlled and the drug is tolerable.

  Recruiting at 48 sites Phase 2 Kiniksa Pharmaceuticals International, plc · Phoenix, Arizona and 47 other locations · NCT07288216

• KPL-387 for recurrent pericarditis

  This trial tests whether KPL-387 can control pain and inflammation and lower the chance of future attacks in people having an acute episode of recurrent pericarditis despite standard treatment.

  Recruiting at 65 sites Phase 2/3 Kiniksa Pharmaceuticals International, plc · Gilbert, Arizona and 66 other locations · NCT07010159

• Using CardiolRx for patients with recurrent pericarditis after stopping IL-1 blockers

  This study is testing if CardiolRx can help people with recurrent pericarditis avoid flare-ups after they stop taking IL-1 blocker therapy.

  Recruiting at 23 sites Phase 3 Cardiol Therapeutics Inc. · Phoenix, Arizona and 26 other locations · NCT06708299

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.