Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis
Condition: Recurrent Pericarditis
MeSH terms: Pericarditis; Recurrence
Intervention: Rilonacept; Placebo
Intervention description: Rilonacept 320 mg (or 4.4 mg/kg in pediatric participants ≥12 and <18 years old) SC , followed by 160 mg (or 2.2 mg/kg in pediatric participants ≥12 and <18 years old) injections once weekly; Placebo SC injections once weekly
Intervention MeSH terms: Rilonacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to assess the efficacy of rilonacept treatment in
      participants with recurrent pericarditis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female aged 12 or older

          2. Has a diagnosis of recurrent pericarditis

          3. Must provide Informed Consent

          4. Presents with at least the third episode of pericarditis during screening.

          5. Has received nonsteroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or
             corticosteroids (in any combination), if used, at stable dose levels (or at least not
             increased) for at least 3 days prior to first study drug administration

          6. Female subjects must be postmenopausal, or incapable of pregnancy or permanently
             sterile, or if of childbearing potential must agree to use highly-effective method of
             contraception.

          7. Must be up-to-date with all immunizations, in agreement with current local
             immunization guidelines for immunosuppressed subjects, before first study drug
             administration.

          8. Is able to adequately maintain a daily subject diary according to protocol.

          9. Agrees to refrain from making any new, major lifestyle changes that may affect
             pericarditis symptoms (e.g., changing exercise pattern) from the time that the
             informed consent form (ICF) is signed through the end of the double-blind randomized
             withdrawal period.

        Key Exclusion Criteria:

          1. Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.

          2. Has a history of immunosuppression, including positive human immunodeficiency virus
             (HIV) test results.

          3. Has a history of myeloproliferative disorder.

          4. Has a history of demyelinating disease or symptoms suggestive of multiple sclerosis.

          5. Has a history of active or latent tuberculosis (TB) prior to screening

          6. Has chest x-ray at screening or within 12 weeks before receiving first administration
             of study drug, with evidence of malignancy or abnormality consistent with prior or
             active TB infection.

          7. Has a history of positive or intermediate results for hepatitis B surface antigen,
             hepatitis B core antibody, or hepatitis C virus antibody at screening.

          8. Has a history of malignancy of any organ system within the past 5 years before
             screening (other than a successfully treated non metastatic cutaneous squamous cell
             carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix).

          9. Has a known or suspected current active 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.

         10. Has had an organ transplant.

         11. In the Investigator's opinion, has a history of alcoholism or drug/chemical abuse
             within 2 years before screening.

         12. Has a known hypersensitivity to rilonacept or to any of its excipients.

         13. Has received an investigational drug during the 30 days before screening or is
             planning to receive an investigational drug (other than that administered during this
             study) or use an investigational device at any time during the study.

         14. In the Investigator's opinion, has any other medical condition that could adversely
             affect the subject's participation or interfere with study evaluations.