VTX2735 SODIUM for Recurrent pericarditis

Inclusion criteria

• {"criterion_text":"- Participants are male or female ≥ 18 years up to ≤ 75 years of age"}
• {"criterion_text":"- A male participant is eligible to participate if they agree to the following during the study treatment period and for at least 90 days after the last dose of study treatment: •\tRefrain from donating sperm •\tAgree to use a male condom with a FOCBP. Female partners of male participants should consider using an additional highly effective contraceptive method with a failure rate of < 1% per year (as listed in Appendix 1 of the protocol)"}
• {"criterion_text":"- Capable of giving signed informed consent and able to comply with the requirements and restrictions listed in the ICF and in the study protocol, including compliance with the SoA."}
• {"criterion_text":"- Previously had pericarditis which, in the judgement of the Investigator based on the available data, met the criteria for an acute pericarditis event, using the 2015 ESC Guidelines for the Diagnosis and Management of Pericardial Diseases (1) as a frame of reference, i.e., met at least 2 of the 4 following criteria: •\tPericarditic chest pain •\tPericardial rub •\tNew widespread ST-segment elevation or PR-segment depression on ECG •\tPericardial effusion (new or worsening) Additional supportive findings could include elevations of markers of inflammation (i.e., CRP, ESR or WBC count) or evidence of pericardial inflammation by an imaging technique (e.g., MRI)."}
• {"criterion_text":"- In the judgement of the Investigator, based upon the available diagnostic information, has an ongoing symptomatic episode of pericarditis, or may have an episode of recurrent pericarditis within the screening period. Participants with an active episode of pericarditis at the screening visit must have Day 1 visit and initiate study treatment as soon as possible; every effort must be made to initiate study treatment within 7 days."}
• {"criterion_text":"- CRP assessed by local laboratory assessment before the first dose of study treatment, either: a.\tCRP > 10 mg/L, or b.\tCRP ≤ 10 mg/L Participants with CRP ≤ 10 mg/L must be receiving concurrent corticosteroid treatment for RP and have evidence of pericardial inflammation by MRI, either at the screening assessment or at a previous pericarditis episode as documented in medical records."}
• {"criterion_text":"- Pericarditis pain score ≥ 4 based on the 11-point NRS."}
• {"criterion_text":"- If participants require treatment with NSAIDs, colchicine, and/or oral corticosteroids (in any combination) based on Investigator judgement, doses of each are required to be stable: •\tNSAIDs and/or colchicine: stable for at least 3 days prior to study treatment •\tOral corticosteroids: stable for at least 7 days prior to study treatment (stable doses for at least 3 days will be acceptable if, in the opinion of the Investigator, a shorter period of stability is not anticipated to alter the baseline CRP value or NRS) •\tIt must be anticipated that the participant will continue NSAIDs, colchicine, and/or oral corticosteroids at the same dose levels for the first 6 weeks of the study."}
• {"criterion_text":"- Agrees to refrain from making any new, major life-style changes that may affect pericarditis symptoms (e.g., starting a new diet or change in exercise pattern) from the time of signature of the ICF to the last on-treatment visit."}
• {"criterion_text":"- A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions (either a or b) applies: a.\tIs not a FOCBP (as defined in Appendix 1 of the protocol) b.\tIs a FOCBP and using a highly effective contraceptive method with a failure rate of < 1% per year, as described in Appendix 1 of the protocol, during the study treatment period and for at least 30 days after the last dose of study treatment. The Investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study treatment. Methods considered highly effective birth control methods are listed in Appendix 1 of the protocol. •\tA FOCBP must have a negative serum pregnancy test at screening. •\tA FOCBP must refrain from donating oocytes for at least 90 days after the last dose of study treatment."}

Exclusion criteria

• {"criterion_text":"- Has a current or prior diagnosis of pericarditis that is secondary to specific prohibited etiologies, including TB; neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); myocarditis; or systemic autoimmune diseases with exception of Still’s disease."}
• {"criterion_text":"- Has a history of malignancy of any organ system within the past 5 years (other than localized carcinoma in situ of the cervix; or fully treated non‑melanoma skin cancers or non-metastatic prostate cancer that has been stable for ≥ 6 months)."}
• {"criterion_text":"- Has a known or suspected currently active clinically significant infection or a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, or an open, draining infected skin wound. Localized skin infection and localized cutaneous tinea are not exclusionary."}
• {"criterion_text":"- Has been treated with oral antibiotics within 2 weeks; or has had a serious infection, has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 2 months of screening."}
• {"criterion_text":"- Has had an organ transplant."}
• {"criterion_text":"- A history of any of the following: a.\tDrug/chemical abuse within 2 years prior to screening b.\tAlcohol abuse c.\tAlcohol intake of ≥ 14 alcohol equivalents per week in the 6 months prior to screening or ≥ 7 alcohol equivalents per week in the month prior to screening"}
• {"criterion_text":"- Significant other cardiovascular disease that would affect the interpretation of study data or the safety of the participant’s participation in the study, per the judgment of the Investigator, including myocardial infarction or unstable angina, heart failure with New York Heart Association Class III or IV symptoms, arterial or venous thrombosis, or stroke within 6 months prior to screening."}
• {"criterion_text":"- Previously received any compound selectively targeting NLRP3, including investigational therapies given in a clinical trial, with the exception of participants enrolling in Cohort B who previously received VTX2735 in this study."}
• {"criterion_text":"- Tests performed at screening that meet any of the following criteria (tests evaluated by the local laboratory obtained as standard of care within 30 days prior to Day 1 are permissible; out of range labs may be rechecked one time, after consultation with the Medical Monitor, before the participant is considered a screen failure): a.\tWBC count < 3.0 × 103 cells/mm3 b.\tANC < 1.5 × 103 cells/mm3 c.\tLymphocyte count < 0.5 × 103 cells/mm3 d.\tPlatelet count < 100 × 103 cells/mm3 e.\tHemoglobin < 9 g/dL f.\tAST or ALT ≥ 2.0 × ULN g.\tTotal bilirubin level > 1.5 × ULN unless the participant has been diagnosed with Gilberts’ disease and this is clearly documented h.\teGFR < 60 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration equation at screening i.\tPresence of HBsAg or positive for total HBcAb, or positive HCV at screening. Successfully treated HCV patients (undetectable HCV RNA) are eligible for enrollment. Participants who are immune due to HBV natural infection or HBV vaccination are eligible. j.\tPositive QuantiFERON®-TB test at screening. A participant who has a screening QuantiFERON-TB test with an indeterminate result may have the test repeated. Participants who had latent TB and received prophylaxis may be eligible upon consultation with the Medical Monitor. k.\tHIV infection, defined as confirmed positive HIV antigen/antibody at screening. l.\tPositive for drugs in the urine drug screen without documented medical explanation. Legal recreational use of tetrahydrocannabinol is not considered exclusionary."}
• {"criterion_text":"- Participants with a confirmed event of QTcF interval prolongation of > 450 msec in males and > 470 msec in females at screening or Day 1."}
• {"criterion_text":"- Uncontrolled arterial hypertension characterized by a systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg at screening or Day 1. One retest may be allowed on a different day during the Screening Period, to allow treatment change or compliance to take effect. Note: Determined by the average of up to 3 consecutive readings. If an initial BP reading/series exceeds the eligibility limit, the BP assessment may be repeated after the participant has rested sitting for ≥ 10 minutes. If the repeat value is less than the criterion limits, the second value may be accepted."}
• {"criterion_text":"- History of clinically significant immunosuppressive disorder, autoimmune/autoinflammatory disorder, primary or secondary immunodeficiency, or disorder with clinically significant effect on CRP."}
• {"criterion_text":"- Any other clinically significant laboratory abnormality that might affect the interpretation of study data or safety of the participant’s participation in the study, per judgment of the Investigator."}
• {"criterion_text":"- Hypersensitivity to any of the VTX2735 excipients."}
• {"criterion_text":"- Positive pregnancy test or lactating female participant."}
• {"criterion_text":"- Clinically important history of a medical disorder that would compromise safety or data quality, per the Investigator's judgment."}
• {"criterion_text":"- Received another investigational drug within 30 days before screening or is planning to receive an investigational drug (other than that administered during this trial) or use an investigational device at any time during the trial."}
• {"criterion_text":"- Has received treatment within 6 months prior to the first dose of study treatment with any systemic immunosuppressants (other than, for example, corticosteroids or mycophenolate) which, in the opinion of the Investigator (in consultation with the Medical Monitor), may interfere with the study endpoints"}
• {"criterion_text":"- Has received treatment within 12 weeks prior to first dose of study treatment with any biologic immunomodulatory therapy (such as TNF-targeted therapy, or IL-1-targeted therapy except as defined in Exclusion Criterion 5), JAK-targeted therapy, or other targeted immunomodulatory therapy."}
• {"criterion_text":"- Has received treatment with IL-1-directed biologic treatments, as follows: rilonacept within 6 weeks or anakinra within 1 week prior to first dose of study treatment; or if any of the following apply:. a.\tParticipant discontinued any IL-1 directed treatment due to lack of efficacy while receiving labeled dosing regimen (as applicable) b.\tParticipant discontinued any IL-1 directed treatment due to safety concerns (other than local injection site reactions)."}
• {"criterion_text":"- Has received treatment within 12 weeks prior to first dose of study treatment with any other biologic or targeted therapy for pericarditis (not including NSAIDs, colchicine, corticosteroid, or cannabidiol treatment), including investigational therapies given in a clinical trial."}
• {"criterion_text":"- Has received treatment within 4 weeks prior to first dose of study treatment with any injected glucocorticoids (including IV, subcutaneous, intramuscular and intrathecal injections, but not including intraarticular injections (a shorter time than 4 weeks will be acceptable if, in the opinion of the Investigator, this is not anticipated to affect participant safety or efficacy assessments)."}
• {"criterion_text":"- Has a history of myeloproliferative disorder, demyelinating disease, or symptoms suggestive of multiple sclerosis."}
• {"criterion_text":"- Receipt of any live vaccine(s) within 28 days prior to the first dose or SARS CoV-2 vaccination within 14 days prior to the first dose of study treatment (Day 1). Approved nonlive vaccines, including SARS-CoV-2, can be administered according to local vaccination standards."}

Primary endpoints

• {"endpoint_text":"- Incidence and severity of AEs, SAEs, and AEs leading to study treatment discontinuation from the first dose through end of the Follow-Up Period.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in NRS over time through Week 6; Percent change from baseline in NRS over time through Week 6","definition_or_measurement_approach":"Per trial objectives: pericardial pain assessed by the NRS instrument (11-point NRS); change from baseline measured through Week 6."}
• {"endpoint_text":"- Change from baseline in hs-CRP over time through Week 6 ; Percent change from baseline in hs-CRP over time through Week 6; Change from baseline in hs-CRP over time through Week 6 in participants with baseline CRP > 10 mg/L ; Percent change from baseline in hs-CRP over time through Week 6 in participants with baseline CRP > 10 mg/L","definition_or_measurement_approach":"Inflammation assessed by hs-CRP (laboratory measurement); change from baseline measured through Week 6; subgroup analyses for baseline CRP > 10 mg/L."}

Methods

• Flyer (K2_Recruitment material_Flyer_BE-NL) — recruitment material in BE-NL for Belgium (patient-facing flyer).
• Doctor-to-doctor letter (K2_Recruitment material_Dr to Dr Letter_Redacted) — healthcare professional outreach in Belgium.
• K1_Recruitment Arrangements (K1_Recruitment Arrangements_BE) — recruitment arrangements document for Belgium.

Belgium

Earliest CTIS Part Ii Submission Date

20-02-2026

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

7

Number Of Sites

2

Number Of Participants

10

Primary sponsor

Full Name

Zomagen Biosciences Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

United Kingdom

Contract research organisations

Name

Suvoda LLC

Responsibilities

3

Name

Psi Cro AG

Responsibilities

1,2,5,6,7,8

Third parties

• {"country":"United States","full_name":"Thermo Fisher Scientific Inc.","duties_or_roles":"10,4,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Voisin Consulting Life Sciences","duties_or_roles":"12","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"1,2,5,6,7,8","organisation_type":"Pharmaceutical company"}