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

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ClinicalTrials.gov Identifier: NCT03737110
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : March 20, 2019
Sponsor:
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)
Estimated Enrollment : 56 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

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: 24 weeks ]
  2. Percentage of days with no or minimal pain [ Time Frame: 24 weeks ]
  3. Proportion of subjects with absent or minimal pericarditis symptoms [ Time Frame: 24 weeks ]
  4. Proportion of subjects with adverse events [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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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
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.

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 ClinicalTrials.gov identifier (NCT number): NCT03737110


Contacts
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Contact: Clinical Operations Manager 781-431-9100 studyinfo@kiniksa.com
Contact: Larisa Collins +1 (781) 690-9519 lcollins@kiniksa.com

Locations
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United States, Georgia
Arthritis and Rheumatology of Georgia Recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
Loretto Hospital Recruiting
Chicago, Illinois, United States, 60644
United States, Minnesota
Minneapolis Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States, 55403
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Cardiology Consultants of Philadelphia Recruiting
Yardley, Pennsylvania, United States, 19067
United States, Texas
Angiocardiac Care of Texas PA Recruiting
Houston, Texas, United States, 77025
BI Research Center Recruiting
Houston, Texas, United States, 77084
Sponsors and Collaborators
Kiniksa Pharmaceuticals, Ltd.
Investigators
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Study Director: Anna Beutler, MD Kiniksa Pharmaceuticals, Ltd.

Additional Information:
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Responsible Party: Kiniksa Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT03737110     History of Changes
Other Study ID Numbers: KPL-914-C002
2018-002719-87 ( EudraCT Number )
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
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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Pericarditis
Heart Diseases
Cardiovascular Diseases
Rilonacept
Anti-Inflammatory Agents