A Phase 2a, Open-Label Pilot Study to Evaluate the Safety/Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VTX2735 in Participants With Recurrent Pericarditis

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Participants are male or female ≥ 18 years up to ≤ 75 years of age.

• 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)

Locations
United States
Arizona
Local Site #840012
RECRUITING
Tucson
California
Local Site #840014
RECRUITING
Orange
Florida
Local Site #840016
RECRUITING
Saint Augustine
Illinois
Local Site #840008
RECRUITING
Chicago
Local Site #840002
RECRUITING
Park Ridge
Kentucky
Local Site #840011
WITHDRAWN
Owensboro
Massachusetts
Local Site #840010
RECRUITING
Boston
Minnesota
Local Site #840005
RECRUITING
Rochester
Ohio
Local Site #840017
RECRUITING
Cleveland
Texas
Local Site #840001
RECRUITING
Houston
Local Site #840019
RECRUITING
Houston
Utah
Local Site #840013
RECRUITING
Salt Lake City
Virginia
Local Site #840018
RECRUITING
Charlottesville
Local Site #840004
RECRUITING
Richmond
Washington
Local Site #840021
RECRUITING
Seattle
Contact Information
Primary
Ventyx Clinical Trial Contact
ClinicalTrials@ventyxbio.com
888-411-5176
Time Frame
Start Date: 2025-01-28
Estimated Completion Date: 2026-10
Participants
Target number of participants: 50
Treatments
Experimental: Cohort A
Experimental: Cohort B Treatment Group B1
Experimental: Cohort B Treatment Group B2
Related Therapeutic Areas
Sponsors
Leads: Zomagen Biosciences Ltd.

This content was sourced from clinicaltrials.gov

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