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A Phase 2/3 study is evaluating an investigational drug (KPL-387) for patients with recurrent pericarditis.
Kiniksa Pericarditis studies keep the beat of research going.
Study volunteers are an essential part of this important research. Thank you for considering participation in this clinical research study. Learn more about the study, eligibility, site locations, and how you may be able to participate.
WHAT IS RECURRENT PERICARDITIS (RP)?
WHAT IS RECURRENT PERICARDITIS (RP)?
Recurrent pericarditis is a painful and debilitating chronic disease marked by repeated episodes of inflammation of the pericardium (the sac that surrounds the heart).
Recurrent pericarditis symptoms may have an impact on quality of life, limit physical activities, and lead to emergency department visits and hospitalizations.
ABOUT THE STUDY
How does the investigational drug work?
KPL-387 is an investigational monoclonal antibody in a liquid formulation with a target profile of once-monthly subcutaneous (under the skin) dosing.
KPL-387 is designed to block a part of the immune system known as the interleukin-1 (IL-1) pathway. This pathway is known to play a key role in causing inflammation in people with RP.
What is the goal of the research study?
The Phase 2 portion of this study is designed to evaluate the efficacy (how well the drug works) and safety of the investigational drug KPL-387. This study is designed to:
- Confirm the dose regimen of KPL-387 to be studied in the Phase 3 portion of the study.
- Have a long-term extension for those who complete the main study.
KPL-387 is an investigational product. The efficacy and safety of KPL-387 have not been evaluated by any regulatory authority.
ARE YOU ELIGIBLE?
ARE YOU ELIGIBLE?
You may qualify for this study if you:
- Are age 18 to 80 years
- Present with signs and symptoms of recurrent pericarditis despite treatment with standard therapies
There are other requirements for taking part in this study. Contact a participating research study location (site) to learn if this study may be appropriate for you or your loved ones. The site’s study team will discuss the above and additional criteria with you to determine if you or your loved one are eligible for the study.
Where are the locations for this research study?
For the most up to date information, please send an email to clinicaltrials@Kiniksa.com. Site locations will be added periodically over the duration of the research study. We do not endorse any specific study sites.
For more information on the trial, please visit: clinicaltrials.gov/study/NCT07010159