Phase 2/3 Study of KPL-387 in Recurrent Pericarditis
Research type
Research Study
Full title
A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants with Recurrent Pericarditis
IRAS ID
1012488
Contact name
Chelsea Aiudi
Contact email
Sponsor organisation
Kiniksa Pharmaceuticals, GmbH
Clinicaltrials.gov Identifier
Research summary
This study is being done to learn if KPL-387 is an effective and safe treatment for recurrent pericarditis. Participants are invited to participate in this study because they have been diagnosed with recurrent pericarditis. Pericarditis is inflammation of the pericardium, two thin layers of a sac-like tissue that surrounds the heart, holds it in place and helps it move within the chest as it pumps. A common symptom of pericarditis is chest pain, caused by the sac’s two layers becoming inflamed or swollen and possibly rubbing against each other.
KPL-387 is a monoclonal antibody. An antibody is a protein made by cells of the immune system to help fight infections. A monoclonal antibody is an antibody made in a laboratory that acts like the antibodies normally made by your body. Monoclonal antibodies are often used as drugs to bind to and block specific activities of human cells that contribute to disease. KPL-387 is designed to block the IL-1 receptor on human cells. The activity of this receptor has been shown to contribute to the inflammation of pericarditis. This study will test whether blocking IL-1 with KPL-387 can reduce signs of inflammation, and the pain that it causes.
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 - Chelsea Research Ethics Committee
REC reference
25/LO/0544
Date of REC Opinion
12 Sep 2025
REC opinion
Further Information Favourable Opinion