Posology Study with Long-Term Extension in Recurrent Pericarditis

Purpose of Study

What is the Purpose of this Study?

The purpose of this study is to determine how well an experimental drug called KPL-387 works for people who are currently taking medications for the treatment of recurrent pericarditis (RP) and whose pericarditis symptoms are currently under control. Pericarditis is inflammation of the pericardium (2 thin layers of a sac-like tissue that surrounds the heart). A common symptom of pericarditis is chest pain, caused by the sac’s layers becoming inflamed or swollen and possibly rubbing against each other. Researchers aim to learn how to safely and effectively transition participants from their current RP treatments to KPL-387. The study also offers an optional long term extension for those patients that opt in to receiving KPL-387 for an additional period of time. KPL-387 is a monoclonal antibody (protein made in a laboratory), which are often used as drugs to block specific activities of human cells that contribute to disease. KPL-387 is designed to block a specific receptor (called IL-1) that has been shown to contribute to the inflammation of the pericardium. This study will test whether blocking IL-1 with KPL-387 can maintain control of RP, and reduce signs of inflammation, as well as the pain that it causes. KPL-387 is a once-monthly injection.


Study Eligibility

Eligibility


Not Available


Study Sites

Where can I participate?



Beverly


What is the full name of this clinical trial?

A Phase 2 Posology Study with Long-Term Extension in Participants with Well-Controlled Recurrent Pericarditis to Evaluate the Efficacy and Safety of Transition Regimens to KPL-387 Monotherapy from Standard Therapies

Study Details
Disease Type/Condition

Other

Principal Investigator
1

Doshi, Shephal

Co-Investigators

Kevin O'Fee

Age Group

Adult

Phase

II

IRB Number

STUDY00004654


How do I learn more about this study?

Email

clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Doshi, Shephal

Age Group

Adult

Phase

II

IRB Number

KPL-387-C212-DOSHI


Contact
Email
clinicaltrials@cshs.org