IMpAct of CardiolRxTM oVer 6 Months Following IL-1 Blocker Cessation in pERICarditis Patients - MAVERIC A Randomized, Double-blind, Placebo-controlled Trial

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients 18 years of age or older

• A history of recurrent pericarditis with stable disease and currently being treated with an IL-1 blocker, scheduled to be discontinued. Stable disease is defined as:

‣ treatment with an IL-1 blocker for at least 12 months,

⁃ free of pericarditis recurrence for at least 6 months and this recurrence, if present, must have occurred in the setting of an interruption or tapering of an IL-1 blocker; and

⁃ treatment with an unchanged dose and regimen of on an IL-1 blocker for at least 3 months prior to randomization.

• Pericarditis pain les or equal than 2 on the 11-point Numerical Rating Scale (NRS) for at least 7 days prior to randomization (Visit 1, Day 1)

• C-Reactive Protein (CRP) \< 1.0 mg/dL during screening within 7 days prior to randomization (Visit 1, Day 1).

• Patients who have had a vasectomy or who are willing to use double barrier contraception methods with partners of childbearing potential during the conduct of the trial and for 2 months after the last dose of trial therapy.

• Patients of childbearing potential willing to use an acceptable method of contraception starting with trial therapy administration and for a minimum of 2 months after trial completion. Otherwise, these patients must be postmenopausal (at least 1 year absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone \[FSH\] ≥ 40 mIU/mL \[or ≥ 40 IU/L\] if less than 2 years postmenopausal) or be surgically sterile.

∙ Acceptable birth control methods that result in a failure rate of less than 1 % include oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); using double-barrier contraception methods with their partners; bilateral tubal occlusion; vasectomised partner; sexual abstinence.

Locations
United States
Arizona
Mayo Clionic Arizona
RECRUITING
Phoenix
California
UCI Health
NOT_YET_RECRUITING
Irvine
Florida
Mayo Clinic
RECRUITING
Jacksonville
Mayo Clinic Florida
RECRUITING
Jacksonville
Illinois
Northwestern University
RECRUITING
Chicago
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University
NOT_YET_RECRUITING
Baltimore
MedStar Health Institute
NOT_YET_RECRUITING
Columbia
Minnesota
Minneapolis Heart Institute
NOT_YET_RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
New York
Columbia University - New York Presbyterian
RECRUITING
New York
Columbia University - New York Presbyterian
RECRUITING
New York
Lenox Hill Hospital
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Texas
Houston Methodist Hospital
RECRUITING
Houston
Utah
University of Utah Hospital
NOT_YET_RECRUITING
Salt Lake City
Virginia
University of Virginia
RECRUITING
Charlottesville
Virginia Commonwealth University
RECRUITING
Richmond
Vermont
University of Vermont
RECRUITING
Burlington
Other Locations
Canada
Jewish General Hospital
RECRUITING
Montreal
Greece
Hippokration General Hospital
RECRUITING
Athens
Italy
Fatebenefratelli Hospital Milano
NOT_YET_RECRUITING
Milan
University of Padua
NOT_YET_RECRUITING
Padua
University Hospital
NOT_YET_RECRUITING
Torino
University Hospital Udine
NOT_YET_RECRUITING
Udine
Contact Information
Primary
Andrea B Parker, MSc., PhD
andrea.parker@cardiolrx.com
+1 289 910 0862
Backup
Heather Dalgleish, MSc.
heather.dalgleish@cardiolrx.com
+1 289 910 0384
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2026-10-21
Participants
Target number of participants: 110
Treatments
Active_comparator: CardiolRx
* Initial starting dose (Day 1, evening dose to Day 3, morning dose):~ 5 mg/kg of body weight CardiolRx b.i.d.~* Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight CardiolRx b.i.d.~* Day 10, evening dose to morning dose of the Week 24 Visit:~ 10 mg/kg of body weight CardiolRx b.i.d.
Placebo_comparator: Placebo
* Initial starting dose (Day 1, evening dose to Day 3, morning dose):~ 5 mg/kg of body weight matching placebo b.i.d.~* Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight matching placebo b.i.d.~* Day 10, evening dose to morning dose of the Week 24 Visit:~ 10 mg/kg of body weight matching placebo b.i.d.
Related Therapeutic Areas
Sponsors
Leads: Cardiol Therapeutics Inc.

This content was sourced from clinicaltrials.gov