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RHAPSODY Phase 3 Study to Assess the Efficacy and Safety of Rilonacept Treatment in Subjects With Recurrent Pericarditis (RHAPSODY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03737110
Recruitment Status : Active, not recruiting
First Posted : November 9, 2018
Last Update Posted : June 23, 2020
Information provided by (Responsible Party):
Kiniksa Pharmaceuticals, Ltd.

Brief Summary:
The purpose of this study is to assess the efficacy and safety of rilonacept treatment in subjects with recurrent pericarditis.

Condition or disease Intervention/treatment Phase
Recurrent Pericarditis Drug: Rilonacept Drug: Placebo Phase 3

Detailed Description:
This is a Phase 3, global, multi-center, double-blind, placebo-controlled, randomized withdrawal study with open-label extension, to assess the efficacy and safety of rilonacept treatment in subjects with recurrent pericarditis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study With Open-label Extension, to Assess the Efficacy and Safety of Rilonacept Treatment in Subjects With Recurrent Pericarditis
Actual Study Start Date : December 6, 2018
Actual Primary Completion Date : May 29, 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Rilonacept

Arm Intervention/treatment
Active Comparator: Rilonacept
Rilonacept SC injections once weekly
Drug: Rilonacept
Rilonacept 320 mg (or 4.4 mg/kg in pediatric subjects ≥12 and <18 years old) SC , followed by 160 mg (or 2.2 mg/kg in pediatric subjects ≥12 and <18 years old) injections once weekly
Other Names:
  • KPL-914
  • Arcalyst® for Cryopyrin-Associated Periodic Syndromes (CAPS)

Placebo Comparator: Placebo
Placebo SC injections once weekly
Drug: Placebo
Placebo SC injections once weekly

Primary Outcome Measures :
  1. Time to pericarditis recurrence [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects who maintained Clinical Response [ Time Frame: 16 weeks ]
  2. Percentage of days with no or minimal pain [ Time Frame: 16 weeks ]
  3. Proportion of subjects with absent or minimal pericarditis symptoms [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03737110

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Sponsors and Collaborators
Kiniksa Pharmaceuticals, Ltd.
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Study Director: John Paolini, M.D. Kiniksa Pharmaceuticals, Ltd.
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kiniksa Pharmaceuticals, Ltd. Identifier: NCT03737110    
Other Study ID Numbers: KPL-914-C002
2018-002719-87 ( EudraCT Number )
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents