Multi-center, randomized, double-blind, placebo-controlled, phase-3 Trial. Patients with a history of recurrent pericarditis who are being treated with an IL-1 blocker for at least 12 months, scheduled to be discontinued, will be approached for potential trial participation. Double-blind treatment will be initiated 10 - 16 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks. The objective is to assess whether patients who discontinue therapy with an IL-1 blocker for recurrent pericarditis remain free of pericarditis recurrence while receiving CardiolRx.
Double-blind, randomized, placebo-controlled Phase-3 trial. The primary objective is to assess whether patients with IL-1 blocker-dependent recurrent pericarditis can discontinue IL-1 blocker therapy and remain free of recurrence while receiving CardiolRx. Before any trial-related procedure is performed, written informed consent will be obtained. After informed consent is obtained, patients will be screened for eligibility. The highest NRS pain score within the past 7 days is to be assessed prior to randomization at Visit 1 (Day 1). Baseline blood samples for central laboratory assessment of hs-CRP and pharmacokinetic assessments should also be collected prior to randomization at Visit 1 (Day 1). All other screening assessments will be performed at any time within 7 days prior to randomization at Visit 1 (Day 1) and include the following: Physical examination, vital signs, 12-lead ECG; C-SSRS and blood draws for local laboratory assessments (see Section 17.2). Eligible patients will be randomized at Visit 1 (Day 1) to either CardiolRx or matching placebo in a 1:1 ratio. Double-blind trial therapy will be initiated in the evening of Day 1, 10 - 16 days (no additional time window is allowed) prior to the last scheduled dose of the IL-1 blocker and after all baseline assessments are completed. Trial therapy will be administered for 24 weeks. Vital signs, ECG recording and blood draws for local and central laboratory analyses will be carried out at selected visits. Concomitant medications and (S)AEs will be recorded at all visits. Final efficacy assessments will take place at Visit 9, 24 weeks after randomization and start of trial therapy and include a physical exam, vital signs, pain score NRS collection, a 12-lead ECG, a C-SSRS, as well as blood draws for local and central laboratory assessments. A virtual safety follow-up visit (Visit 10) will be scheduled 4 weeks after the last trial therapy administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
110
The intervention will be administered orally (via syringe) with food twice daily.
Mayo Clionic Arizona
Phoenix, Arizona, United States
RECRUITINGUCI Health
Irvine, California, United States
NOT_YET_RECRUITINGMayo Clinic Florida
Jacksonville, Florida, United States
RECRUITINGMayo Clinic
Jacksonville, Florida, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGJohns Hopkins University
Baltimore, Maryland, United States
NOT_YET_RECRUITINGMedStar Health Institute
Columbia, Maryland, United States
NOT_YET_RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGMinneapolis Heart Institute
Minneapolis, Minnesota, United States
NOT_YET_RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITING...and 16 more locations
Recurrence of pericarditis
proportions of patients free from a new episode of recurrent pericarditis\* from the timepoint of stopping the IL-1 blocker to Week 24
Time frame: 24 weeks
Percentage of days with no or minimal pain
the percentage of days with no or minimal pain as assessed by an NRS score ≤ 2 from the timepoint of stopping the IL-1 blocker to Visit 9 (Week 24)
Time frame: 24 weeks
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