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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.
 
ClinicalTrials.gov Identifier: NCT03737110
Recruitment Status : Active, not recruiting
First Posted : November 9, 2018
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Kiniksa Pharmaceuticals, Ltd.

Tracking Information
First Submitted Date  ICMJE October 30, 2018
First Posted Date  ICMJE November 9, 2018
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE December 6, 2018
Actual Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
Time to pericarditis recurrence [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • Proportion of subjects who maintained Clinical Response [ Time Frame: 16 weeks ]
  • Percentage of days with no or minimal pain [ Time Frame: 16 weeks ]
  • Proportion of subjects with absent or minimal pericarditis symptoms [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
  • Proportion of subjects who maintained Clinical Response [ Time Frame: 24 weeks ]
  • Percentage of days with no or minimal pain [ Time Frame: 24 weeks ]
  • Proportion of subjects with absent or minimal pericarditis symptoms [ Time Frame: 24 weeks ]
  • Proportion of subjects with adverse events [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RHAPSODY Phase 3 Study to Assess the Efficacy and Safety of Rilonacept Treatment in Subjects With Recurrent Pericarditis
Official Title  ICMJE 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
Brief Summary The purpose of this study is to assess the efficacy and safety of rilonacept treatment in subjects with recurrent pericarditis.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Pericarditis
Intervention  ICMJE
  • 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)
  • Drug: Placebo
    Placebo SC injections once weekly
Study Arms  ICMJE
  • Active Comparator: Rilonacept
    Rilonacept SC injections once weekly
    Intervention: Drug: Rilonacept
  • Placebo Comparator: Placebo
    Placebo SC injections once weekly
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 11, 2020)
86
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2018)
56
Estimated Study Completion Date  ICMJE June 2022
Actual Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Israel,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03737110
Other Study ID Numbers  ICMJE KPL-914-C002
2018-002719-87 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kiniksa Pharmaceuticals, Ltd.
Study Sponsor  ICMJE Kiniksa Pharmaceuticals, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Paolini, M.D. Kiniksa Pharmaceuticals, Ltd.
PRS Account Kiniksa Pharmaceuticals, Ltd.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP