ClinicalTrials.gg
RecruitingNCT06836232Updated Oct 9, 2026

An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

A Phase 2 interventional study of VTX2735 and VTX2735 in Recurrent Pericarditis, sponsored by Zomagen Biosciences Ltd.. Recruiting at 20 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Zomagen Biosciences Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Updated Oct 9, 2026First site in GreeceSite recruiting status changed+2 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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
02

Conditions studied

  • Recurrent Pericarditis

Browse trials for

Keywords

  • Ventyx
  • Zomagen
  • Recurrent Pericarditis
  • VTX2735
  • NLRP3 Inhibitor
  • NLRP3
  • Inflammasome
03

In context

Pericarditis

54 studies on the registry are indexed under Pericarditis; 23 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 29 interventional studies indexed under Pericarditis.

Browse Pericarditis studies →

Lead sponsor

Zomagen Biosciences Ltd. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Current or prior diagnosis of pericarditis that is secondary to specific prohibited causes, including but not limited to tuberculosis, blunt trauma, tumor, myocarditis, or systemic diseases.
  • History of disorder, autoimmune/autoinflammatory disorder, or primary or secondary immunodeficiency.
  • Clinically important history of a medical disorder that would compromise safety or data quality, per the Investigator's judgment.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Cohort A

    Drug: VTX2735

  • Experimental
    Cohort B Treatment Group B1

    Drug: VTX2735

  • Experimental
    Cohort B Treatment Group B2

    Drug: VTX2735

  • Experimental
    Cohort C Treatment Group C1

    Drug: VTX2735

  • Experimental
    Cohort C Treatment Group C2

    Drug: VTX2735

Interventions

  • DrugVTX2735

    Dose A, Daily

    Also known as: LY5625574

  • DrugVTX2735

    Dose B, Daily

    Also known as: LY5625574

  • DrugVTX2735

    Dose C, Daily

    Also known as: LY5625574

  • DrugVTX2735

    Dose D, Daily

    Also known as: LY5625574

  • DrugVTX2735

    Dose E, Daily

    Also known as: LY5625574

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of VTX2735

    Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation

    Time frame: Day 1 of treatment period through study completion, up to 26 weeks

Secondary outcomes

  1. Effect of VTX2735 on pericardial pain

    Change from baseline in Numeric Pain Rating Scale (NRS) over time through Week 6

    Time frame: Day 1 of treatment period to Week 6 of treatment period

  2. Effect of VTX2735 on inflammation

    Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP) over time through Week 6

    Time frame: Day 1 of treatment period to Week 6 of treatment period

07

Study locations

18 of 20 sites recruiting
  • Site Location #840023
    La Jolla, California 92037, United States
    Recruiting
  • Local Site #840014
    Orange, California 92868, United States
    Recruiting
  • Local Site #840016
    Saint Augustine, Florida 32086, United States
    Recruiting
  • Local Site #840008
    Chicago, Illinois 60611, United States
    Recruiting
  • Local Site #840010
    Boston, Massachusetts 02114, United States
    Recruiting
  • Local Site #840005
    Rochester, Minnesota 55905-0002, United States
    Recruiting
    • Sushil Luis · Principal investigator
  • Local Site #840020
    New York, New York 10032, United States
    Recruiting
  • Local Site #840017
    Cleveland, Ohio 44195, United States
    Recruiting
  • Local Site #840019
    Houston, Texas 77030, United States
    Recruiting
    • Maan Malahfji · Principal investigator
  • Local Site #840001
    Houston, Texas 77034, United States
    Recruiting
  • Local Site #840013
    Salt Lake City, Utah 84132, United States
    Recruiting
  • Local Site #840022
    Burlington, Vermont 05401, United States
    Recruiting
  • Local Site #840004
    Richmond, Virginia 23298, United States
    Recruiting
  • Local Site #840018
    Richmond, Virginia 23298, United States
    Recruiting
  • Local Site #840021
    Seattle, Washington 98105, United States
    Recruiting
  • Local Site #056001
    Ghent, 9000, Belgium
    Recruiting
  • Local Site #056002
    Leuven, 3000, Belgium
    Recruiting
  • Local Site #840102
    Montreal, H4A 3J1, Canada
    Not yet recruiting
  • Local Site #840101
    Ottawa, K1Y 4S7, Canada
    Recruiting
  • Local Site #300001
    Athens, 11527, Greece
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2025 (actual). Primary completion is estimated for Oct 2027, 33 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2025
First posted
Feb 20, 2025
StartActual
Jan 28, 2025
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2027
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
21 sites added, 20 sites removed — first site in Greece. 4 sites changed recruiting status (4 now recruiting)
Show 4 sites
  • UC San Diego Health · La Jolla, United StatesNot yet recruiting→Recruiting
  • University of Vermont Medical Center · Burlington, United StatesNot yet recruiting→Recruiting
  • University Hospital Ghent · Ghent, BelgiumNot yet recruiting→Recruiting
  • University Hospitals Leuven, Campus Gasthuisberg · Leuven, BelgiumNot yet recruiting→Recruiting
Show 21 added (15 United States, 2 Greece, 2 Belgium, 2 Canada)
  • General Hospital of Athens "Ippokratio" · Athens, Greece
  • Site Location #840023 · La Jolla, United States
  • Local Site #840014 · Orange, United States
  • Local Site #840016 · Saint Augustine, United States
  • Local Site #840008 · Chicago, United States
  • Local Site #840010 · Boston, United States
  • Local Site #840005 · Rochester, United States
  • Local Site #840020 · New York, United States
  • Local Site #840017 · Cleveland, United States
  • Local Site #840019 · Houston, United States
  • Local Site #840001 · Houston, United States
  • Local Site #840013 · Salt Lake City, United States
  • Local Site #840022 · Burlington, United States
  • Local Site #840004 · Richmond, United States
  • Local Site #840018 · Richmond, United States
  • Local Site #840021 · Seattle, United States
  • Local Site #056001 · Ghent, Belgium
  • Local Site #056002 · Leuven, Belgium
  • Local Site #840102 · Montreal, Canada
  • Local Site #840101 · Ottawa, Canada
  • Local Site #300001 · Athens, Greece
Show 20 removed
  • UC San Diego Health · La Jolla, United States
  • University of California Irvine Medical Center · Orange, United States
  • Flourish Research - St. Augustine - PPDS · Saint Augustine, United States
  • Bluhm Cardiovascular Institute of Northwestern · Chicago, United States
  • MGH Heart Failure and Cardiac Transplant Center Corrigan Minehan Heart Center · Boston, United States
  • Mayo Clinic · Rochester, United States
  • Columbia University Irving Medical Center · New York, United States
  • The Cleveland Clinic Foundation · Cleveland, United States
  • Houston Methodist Hospital · Houston, United States
  • Orion Medical · Houston, United States
  • University of Utah · Salt Lake City, United States
  • University of Vermont Medical Center · Burlington, United States
  • University of Virginia Health System Advanced Heart Failure and Transplant Center · Richmond, United States
  • VCU North Hospital · Richmond, United States
  • Seattle Children's Hospital · Seattle, United States
  • University Hospital Ghent · Ghent, Belgium
  • University Hospitals Leuven, Campus Gasthuisberg · Leuven, Belgium
  • McGill University Health Centre · Montreal, Canada
  • University of Ottawa Heart Institute · Ottawa, Canada
  • General Hospital of Athens "Ippokratio" · Athens, Greece
across 2 updates, Oct 6, 2026 – Oct 9, 2026
Show all 2 updates
  1. Oct 9, 2026
    20 sites added, 20 sites removed
    Show 20 added (15 United States, 2 Belgium, 2 Canada, 1 Greece)
    • Site Location #840023 · La Jolla, United States
    • Local Site #840014 · Orange, United States
    • Local Site #840016 · Saint Augustine, United States
    • Local Site #840008 · Chicago, United States
    • Local Site #840010 · Boston, United States
    • Local Site #840005 · Rochester, United States
    • Local Site #840020 · New York, United States
    • Local Site #840017 · Cleveland, United States
    • Local Site #840019 · Houston, United States
    • Local Site #840001 · Houston, United States
    • Local Site #840013 · Salt Lake City, United States
    • Local Site #840022 · Burlington, United States
    • Local Site #840004 · Richmond, United States
    • Local Site #840018 · Richmond, United States
    • Local Site #840021 · Seattle, United States
    • Local Site #056001 · Ghent, Belgium
    • Local Site #056002 · Leuven, Belgium
    • Local Site #840102 · Montreal, Canada
    • Local Site #840101 · Ottawa, Canada
    • Local Site #300001 · Athens, Greece
    Show 20 removed
    • UC San Diego Health · La Jolla, United States
    • University of California Irvine Medical Center · Orange, United States
    • Flourish Research - St. Augustine - PPDS · Saint Augustine, United States
    • Bluhm Cardiovascular Institute of Northwestern · Chicago, United States
    • MGH Heart Failure and Cardiac Transplant Center Corrigan Minehan Heart Center · Boston, United States
    • Mayo Clinic · Rochester, United States
    • Columbia University Irving Medical Center · New York, United States
    • The Cleveland Clinic Foundation · Cleveland, United States
    • Houston Methodist Hospital · Houston, United States
    • Orion Medical · Houston, United States
    • University of Utah · Salt Lake City, United States
    • University of Vermont Medical Center · Burlington, United States
    • University of Virginia Health System Advanced Heart Failure and Transplant Center · Richmond, United States
    • VCU North Hospital · Richmond, United States
    • Seattle Children's Hospital · Seattle, United States
    • University Hospital Ghent · Ghent, Belgium
    • University Hospitals Leuven, Campus Gasthuisberg · Leuven, Belgium
    • McGill University Health Centre · Montreal, Canada
    • University of Ottawa Heart Institute · Ottawa, Canada
    • General Hospital of Athens "Ippokratio" · Athens, Greece
  2. Oct 6, 2026
    1 site added — first site in Greece. 4 sites changed recruiting status (4 now recruiting)
    Show 4 sites
    • UC San Diego Health · La Jolla, United StatesNot yet recruiting→Recruiting
    • University of Vermont Medical Center · Burlington, United StatesNot yet recruiting→Recruiting
    • University Hospital Ghent · Ghent, BelgiumNot yet recruiting→Recruiting
    • University Hospitals Leuven, Campus Gasthuisberg · Leuven, BelgiumNot yet recruiting→Recruiting
    Show site
    • General Hospital of Athens "Ippokratio" · Athens, Greece
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06836232
Lead sponsor
Zomagen Biosciences Ltd.
Responsible party
Sponsor
First posted
Feb 20, 2025
Start date
Jan 28, 2025
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Oct 9, 2026

Study contacts

Ventyx Clinical Trial Contact
Contact
ClinicalTrials@ventyxbio.com
888-411-5176 ext. ext 108

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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