Transition Regimens to KPL-387 Monotherapy in Participants with Controlled Recurrent Pericarditis
Research type
Research Study
Full title
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
IRAS ID
1013001
Contact name
Chelsea Aiudi
Contact email
Sponsor organisation
Kiniksa Pharmaceuticals, GmbH
Research summary
This study is being done to see how well KPL-387 works for people who are currently taking medications for the treatment of recurrent pericarditis and whose pericarditis symptoms are currently under control, and to learn how to safely and effectively transition patients from their current treatments for recurrent pericarditis (RP) to KPL-387. The study will also follow those who take part for an additional period of time to see the long-term effects of KPL-387. Participants will be asked to take part in this study because they are taking medication(s) to treat their RP and their RP is controlled. Pericarditis is when the area around the heart (called the pericardium) gets swollen. The pericardium is a thin layer of tissue that covers the heart and lets the heart move as it beats. When it gets swollen, it can cause chest pain.
KPL-387 is a medicine called a monoclonal antibody. The body makes antibodies to help fight infections. Monoclonal antibodies are lab-made antibodies that can be used to treat some diseases. KPL-387 is made to block a part of the body called the IL-1 receptor. The IL-1 receptor is known to cause inflammation and chest pain in pericarditis. The Sponsor is testing KPL-387 for the treatment of recurrent pericarditis. KPL-387 is considered an investigational drug because it is not yet approved by a regulatory authority, for the treatment of recurrent pericarditis.REC name
London - Fulham Research Ethics Committee
REC reference
25/LO/0784
Date of REC Opinion
17 Nov 2025
REC opinion
Further Information Favourable Opinion