An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Part of paid clinical trials in La Jolla, California.

Sponsor
Zomagen Biosciences Ltd.
Study ID
NCT06836232
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent Pericarditis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

First listed
Feb 20, 2025
Start date
Jan 28, 2025
Status verified
Sep 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
  • Experimental: Cohort B Treatment Group B1
  • Experimental: Cohort B Treatment Group B2
  • Experimental: Cohort C Treatment Group C1
  • Experimental: Cohort C Treatment Group C2

Primary Outcome Measure

Safety and tolerability of VTX2735 [ Time Frame: Day 1 of treatment period through study completion, up to 26 weeks ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
UC San Diego HealthLa JollaCalifornia92037
Ajit Raisinghani (PRINCIPAL_INVESTIGATOR)
University of California Irvine Medical CenterOrangeCalifornia92868
Amin Sabet (PRINCIPAL_INVESTIGATOR)
Flourish Research - St. Augustine - PPDSSaint AugustineFlorida32086
Ameeth Vedre (PRINCIPAL_INVESTIGATOR)
Bluhm Cardiovascular Institute of NorthwesternChicagoIllinois60611
Mohamed Al-Kazaz (PRINCIPAL_INVESTIGATOR)
MGH Heart Failure and Cardiac Transplant Center Corrigan Minehan Heart CenterBostonMassachusetts02114
Jonathan Salik (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905-0002
Sushil Luis (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Dor Lotan (PRINCIPAL_INVESTIGATOR)
The Cleveland Clinic FoundationClevelandOhio44195
Allan Klein (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Maan Malahfji (PRINCIPAL_INVESTIGATOR)
Orion MedicalHoustonTexas77034
Karan Bhalla (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84132
Libo Wang (PRINCIPAL_INVESTIGATOR)
University of Vermont Medical CenterBurlingtonVermont05401
Tracy Hagerty (PRINCIPAL_INVESTIGATOR)
University of Virginia Health System Advanced Heart Failure and Transplant CenterRichmondVirginia23298
Antonio Abbate (PRINCIPAL_INVESTIGATOR)
VCU North HospitalRichmondVirginia23298
Georgia Thomas (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Michael Portman (PRINCIPAL_INVESTIGATOR)

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UC San Diego Health· La Jolla, CAUniversity of California Irvine Medical Center· Orange, CAFlourish Research - St. Augustine - PPDS· Saint Augustine, FLBluhm Cardiovascular Institute of Northwestern· Chicago, ILMGH Heart Failure and Cardiac Transplant Center Corrigan Minehan Heart Center· Boston, MAMayo Clinic· Rochester, MN

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