RECRUITING

Rilonacept in Subjects with Cardiac Sarcoidosis

Conditions

Cardiac Sarcoidosis Sarcoid Myocarditis Myocarditis Inflammation PET scan Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to evaluate the effect of rilonacept, added to standard therapy and compared with standard therapy alone, on improvement in myocardial inflammation in subjects with cardiac sarcoidosis after 24 weeks of therapy.

Official Title

A RandomizEd PhAse II TrIal of Rilonacept in Subjects with Cardiac Sarcoidosis (REPAIR-CS)

Quick Facts

Study Start:2025-01

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06660732

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Able to comprehend and willing to sign an ICF and to abide by the study restrictions and requirements 2. Age ≥ 18 years and ≤ 80 years 3. Female subjects must be: * postmenopausal, defined as at least 12 months post cessation of menses (without an alternative medical cause), or * permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation, or having a male partner with vasectomy as affirmed by the subject, or * nonpregnant, nonlactating, and having agreed to use an effective method of contraception (i.e., hormonal contraception, intrauterine device \[IUD\], or double barrier methods such as condom plus diaphragm or diaphragm plus spermicide or condom plus spermicide) from Screening Visit 1 until 5 months after study drug administration, if sexually active. 4. Male subjects must have documented vasectomy or must use double barrier methods of contraception (such as condom plus diaphragm or diaphragm plus spermicide or condom plus spermicide) or use condoms plus hormonal contraceptives or condoms plus IUD with their female partners of childbearing potential from randomization to 3 months after the last dose of study drug administration. Male subjects must agree to refrain from donating sperm during this time period. 5. Has completed recommended vaccinations per current guidelines prior to first dose of study drug	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Able to comprehend and willing to sign an ICF and to abide by the study restrictions and requirements
2. Age ≥ 18 years and ≤ 80 years
3. Female subjects must be:
* postmenopausal, defined as at least 12 months post cessation of menses (without an alternative medical cause), or
* permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation, or having a male partner with vasectomy as affirmed by the subject, or
* nonpregnant, nonlactating, and having agreed to use an effective method of contraception (i.e., hormonal contraception, intrauterine device \[IUD\], or double barrier methods such as condom plus diaphragm or diaphragm plus spermicide or condom plus spermicide) from Screening Visit 1 until 5 months after study drug administration, if sexually active.
4. Male subjects must have documented vasectomy or must use double barrier methods of contraception (such as condom plus diaphragm or diaphragm plus spermicide or condom plus spermicide) or use condoms plus hormonal contraceptives or condoms plus IUD with their female partners of childbearing potential from randomization to 3 months after the last dose of study drug administration. Male subjects must agree to refrain from donating sperm during this time period.
5. Has completed recommended vaccinations per current guidelines prior to first dose of study drug

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Lezlie Peterson, R.N.

CONTACT

507-255-2029

Johnson.Lezlie@mayo.edu

Principal Investigator

Andrew Rosenbaum

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Johns Hopkins University

Baltimore, Maryland, 21205

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Andrew Rosenbaum, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01

Study Completion Date2027-03

Study Record Updates

Study Start Date2025-01

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

Cardiac Sarcoidosis
Sarcoid Myocarditis
Myocarditis
Inflammation
PET scan
Heart Failure

Additional Relevant MeSH Terms

Cardiac Sarcoidosis