Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kiniksa Pharmaceuticals (UK), Ltd.; Kiniksa Pharmaceuticals, Ltd.
• Treatments: Rilonacept

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.