An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis
NCT06836232 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-05-22
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
Conditions
- Recurrent Pericarditis
Interventions
- DRUG
-
VTX2735
Dose A, Daily
- DRUG
-
VTX2735
Dose B, Daily
- DRUG
-
VTX2735
Dose C, Daily
- DRUG
-
VTX2735
Dose D, Daily
- DRUG
-
VTX2735
Dose E, Daily
Sponsors & Collaborators
-
Zomagen Biosciences Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-28
- Primary Completion
- 2027-10-31
- Completion
- 2027-10-31
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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