An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis
NCT ID: NCT06836232
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2025-01-28
2026-10-31
Brief Summary
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Cohort A will include up to 30 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 up to 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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A
VTX2735
Dose A, daily
VTX2735
Dose B, Daily
Cohort B Treatment Group B1
VTX2735
Dose B, Daily
Cohort B Treatment Group B2
VTX2735
Dose C, daily
Interventions
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VTX2735
Dose A, daily
VTX2735
Dose B, Daily
VTX2735
Dose C, daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Zomagen Biosciences Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Henrik Sonnergren, MD, PhD
Role: STUDY_DIRECTOR
Ventyx Biosciences
Locations
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Local Site #840012
Tucson, Arizona, United States
Local Site #840014
Orange, California, United States
Local Site #840016
Saint Augustine, Florida, United States
Local Site #840008
Chicago, Illinois, United States
Local Site #840002
Park Ridge, Illinois, United States
Local Site #840011
Owensboro, Kentucky, United States
Local Site #840010
Boston, Massachusetts, United States
Local Site #840005
Rochester, Minnesota, United States
Local Site #840020
New York, New York, United States
Local Site #840017
Cleveland, Ohio, United States
Local Site #840019
Houston, Texas, United States
Local Site #840001
Houston, Texas, United States
Local Site #840013
Salt Lake City, Utah, United States
Local Site #840018
Charlottesville, Virginia, United States
Local Site #840004
Richmond, Virginia, United States
Local Site #840021
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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VTX2735-202
Identifier Type: -
Identifier Source: org_study_id
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