Actively Recruiting
A Phase 2a, Open-Label Pilot Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VTX2735 in Participants With Recurrent Pericarditis
Led by Zomagen Biosciences Ltd. · Updated on 2026-05-22
50
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying VTX2735 to understand its safety and effectiveness in people diagnosed with Recurrent Pericarditis. This Phase 2a open-label pilot study aims to evaluate how well participants tolerate the drug and how it affects pain and inflammation related to their condition. Participants will be adults aged 18 to 75 years who have experienced an episode of pericarditis and currently have symptoms or a risk of recurrence within the next four weeks. The study includes three groups (Cohorts A, B, and C) with different dosing schedules of VTX2735. Each cohort begins with a 30-day screening period to assess eligibility. Cohort A participants receive Dose A daily for 6 weeks, with possible extensions including the same dose or Dose B for up to 7 weeks and 11 weeks respectively, followed by a 14-day follow-up. Cohorts B and C also receive daily doses of VTX2735 (various doses B, C, D, or E) during a 6-week treatment period, with possible 18-week extension periods and a 14-day follow-up. Participants will have their symptoms, such as pericardial pain and inflammation, monitored regularly during treatment. Safety and tolerability of VTX2735 are tracked from the first day of treatment through study completion, up to 26 weeks. The study involves assessments like pain scoring and blood tests for inflammation markers. Overall, participants can expect regular visits for treatment, monitoring, and follow-up over several months as researchers gather information on the drug's effects and safety.
CONDITIONS
Brief Title
An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants are male or female aged 18 to 75 years.
- Able to give informed consent and follow study procedures.
- Had a first episode of acute pericarditis.
- Have ongoing symptoms or risk of recurrent pericarditis within 4 weeks.
- CRP measured before first dose; if CRP ≤ 10 mg/L, must be on corticosteroids with inflammation evidence.
- Pericarditis pain score of 4 or higher on an 11-point scale.
- Stable doses of NSAIDs, colchicine, and/or oral corticosteroids if used.
You will not qualify if you...
- Pericarditis caused by tuberculosis, blunt trauma, tumor, myocarditis, or systemic autoimmune diseases.
- History of significant immunosuppressive or autoimmune/autoinflammatory disorders, or immunodeficiency.
- Medical conditions that could compromise safety or data quality as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 26 weeks
Participants receive daily doses of VTX2735 to evaluate safety, tolerability, and effectiveness for recurrent pericarditis.
Weekly visits for up to 26 weeks
Trial Site Locations
Total: 18 locations
1
Local Site #840012
Tucson, Arizona, United States, 85718
Withdrawn
2
Local Site #840014
Orange, California, United States, 92868
Actively Recruiting
3
Local Site #840016
Saint Augustine, Florida, United States, 32086
Actively Recruiting
4
Local Site #840008
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Local Site #840002
Park Ridge, Illinois, United States, 60068
Withdrawn
6
Local Site #840011
Owensboro, Kentucky, United States, 42303
Withdrawn
7
Local Site #840010
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Local Site #840005
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Local Site #840020
New York, New York, United States, 10032
Actively Recruiting
10
Local Site #840017
Cleveland, Ohio, United States, 44195
Actively Recruiting
11
Local Site #840019
Houston, Texas, United States, 77030
Actively Recruiting
12
Local Site #840001
Houston, Texas, United States, 77034
Actively Recruiting
13
Local Site #840013
Salt Lake City, Utah, United States, 84132
Actively Recruiting
14
Local Site #840022
Burlington, Vermont, United States, 05401
Actively Recruiting
15
Local Site #840018
Charlottesville, Virginia, United States, 22908
Actively Recruiting
16
Local Site #840004
Richmond, Virginia, United States, 23219
Actively Recruiting
17
Local Site #840021
Seattle, Washington, United States, 98105
Actively Recruiting
18
Local Site #840101
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
Research Team
V
Ventyx Clinical Trial Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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