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

First listed
Feb 20, 2025
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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