Recurrent PericarditisPhase 2NCT06836232
An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis
A Phase 2 study testing VTX2735 in people with Recurrent Pericarditis, run by Zomagen Biosciences Ltd. at 20 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Pericarditis
- What is being tested?
- VTX2735
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 28 Jan 2025to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 autoimmune diseases.
- History of clinically significant immunosuppressive 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.
Trial locations and contacts
20 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 4 countries
United States15 sites, 15 recruiting
- Recruiting
Local Site #840010
Boston, Massachusetts, 02114
- Recruiting
Local Site #840022
Burlington, Vermont, 05401
- Recruiting
Local Site #840008
Chicago, Illinois, 60611
- Recruiting
Local Site #840017
Cleveland, Ohio, 44195
- Recruiting
Local Site #840019
Houston, Texas, 77030
Maan Malahfji
- Recruiting
Local Site #840001
Houston, Texas, 77034
- Recruiting
Site Location #840023
La Jolla, California, 92037
- Recruiting
Local Site #840020
New York, New York, 10032
- Recruiting
Local Site #840014
Orange, California, 92868
- Recruiting
Local Site #840004
Richmond, Virginia, 23298
- Recruiting
Local Site #840018
Richmond, Virginia, 23298
- Recruiting
Local Site #840005
Rochester, Minnesota, 55905-0002
Sushil Luis
- Recruiting
Local Site #840016
Saint Augustine, Florida, 32086
- Recruiting
Local Site #840013
Salt Lake City, Utah, 84132
- Recruiting
Local Site #840021
Seattle, Washington, 98105
Belgium2 sites, 2 recruiting
- Recruiting
Local Site #056001
Ghent, 9000
- Recruiting
Local Site #056002
Leuven, 3000
Canada2 sites, 2 recruiting
- Not yet recruiting
Local Site #840102
Montreal, H4A 3J1
- Recruiting
Local Site #840101
Ottawa, K1Y 4S7
About this study
Official title: A Phase 2a, Open-Label Pilot Study to Evaluate the Safety/Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VTX2735 in Participants With Recurrent Pericarditis
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:
Read more
- 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
- Conditions
- Recurrent Pericarditis
- Being tested
- VTX2735
- Keywords
- Ventyx, Zomagen, Recurrent Pericarditis, VTX2735, NLRP3 Inhibitor, NLRP3, Inflammasome
- Medical subject headings
- Pericarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VTX2735Drug
Also called LY5625574
Dose A, Daily
VTX2735Drug
Also called LY5625574
Dose B, Daily
VTX2735Drug
Also called LY5625574
Dose C, Daily
VTX2735Drug
Also called LY5625574
Dose D, Daily
VTX2735Drug
Also called LY5625574
Dose E, Daily
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Not described Receives: Drug: VTX2735 |
| Cohort B Treatment Group B1 | Experimental | Not described Receives: Drug: VTX2735 |
| Cohort B Treatment Group B2 | Experimental | Not described Receives: Drug: VTX2735 |
| Cohort C Treatment Group C1 | Experimental | Not described Receives: Drug: VTX2735 |
| Cohort C Treatment Group C2 | Experimental | Not described Receives: Drug: VTX2735 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of VTX2735
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation
Measured: Day 1 of treatment period through study completion, up to 26 weeks
Secondary outcomes (2)
Effect of VTX2735 on pericardial pain
Change from baseline in Numeric Pain Rating Scale (NRS) over time through Week 6
Measured: Day 1 of treatment period to Week 6 of treatment period
Effect of VTX2735 on inflammation
Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP) over time through Week 6
Measured: Day 1 of treatment period to Week 6 of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start28 Jan 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent PericarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zomagen Biosciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836232
- Sponsor's protocol ID
- 27930
- Other IDs
- J7W-MC-ELCA, VTX2735-202
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-Label Pilot Study to Evaluate the Safety/Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VTX2735 in Participants With Recurrent Pericarditis
- ClinicalTrials.gov ID
- NCT06836232
- Acronym / sponsor ID
- 27930
- Conditions
- Recurrent Pericarditis
- Keywords
- Ventyx, Zomagen, Recurrent Pericarditis, VTX2735, NLRP3 Inhibitor, NLRP3, Inflammasome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zomagen Biosciences Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: VTX2735 |
| Cohort B Treatment Group B1 | Experimental | Drug: VTX2735 |
| Cohort B Treatment Group B2 | Experimental | Drug: VTX2735 |
| Cohort C Treatment Group C1 | Experimental | Drug: VTX2735 |
| Cohort C Treatment Group C2 | Experimental | Drug: VTX2735 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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 autoimmune diseases.
- History of clinically significant immunosuppressive 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VTX2735Also: LY5625574Dose A, Daily | Drug | Cohort A |
| VTX2735Also: LY5625574Dose B, Daily | Drug | Cohort A, Cohort B Treatment Group B1, Cohort C Treatment Group C1, Cohort C Treatment Group C2 |
| VTX2735Also: LY5625574Dose C, Daily | Drug | Cohort B Treatment Group B2 |
| VTX2735Also: LY5625574Dose D, Daily | Drug | Cohort C Treatment Group C1 |
| VTX2735Also: LY5625574Dose E, Daily | Drug | Cohort C Treatment Group C2 |
Primary outcome
Safety and tolerability of VTX2735
Time frame: Day 1 of treatment period through study completion, up to 26 weeks
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation
2 secondary outcomes
Effect of VTX2735 on pericardial pain
Time frame: Day 1 of treatment period to Week 6 of treatment period
Effect of VTX2735 on inflammation
Time frame: Day 1 of treatment period to Week 6 of treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VTX2735 in people with Recurrent Pericarditis, run by Zomagen Biosciences Ltd. at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Belgium, Canada, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ventyx Clinical Trial Contact (888-411-5176 ext. ext 108, ClinicalTrials@ventyxbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of VTX2735 (time frame: Day 1 of treatment period through study completion, up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.