An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Zomagen Biosciences Ltd.
Study ID
NCT06836232
Phase
PHASE2
Status
Recruiting
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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

Start date
Jan 28, 2025
Status verified
May 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 (17)

FacilityCityStateZIPSite coordinators
Local Site #840012TucsonArizona85718-
Local Site #840014OrangeCalifornia92868-
Local Site #840016Saint AugustineFlorida32086-
Local Site #840008ChicagoIllinois60611-
Local Site #840002Park RidgeIllinois60068-
Local Site #840011OwensboroKentucky42303-
Local Site #840010BostonMassachusetts02114-
Local Site #840005RochesterMinnesota55905-
Local Site #840020New YorkNew York10032-
Local Site #840017ClevelandOhio44195-
Local Site #840001HoustonTexas77034-
Local Site #840019HoustonTexas77030-
Local Site #840013Salt Lake CityUtah84132-
Local Site #840022BurlingtonVermont05401-
Local Site #840018CharlottesvilleVirginia22908-
Local Site #840004RichmondVirginia23219-
Local Site #840021SeattleWashington98105-

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