Rilonacept in Subjects with Cardiac Sarcoidosis

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.

Conditions

Cardiac Sarcoidosis

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Study Overview

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Study Details

Study overview

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.

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

Rilonacept in Subjects with Cardiac Sarcoidosis

Condition
Cardiac Sarcoidosis
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21205

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Andrew Rosenbaum, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2027-03