KPL-387 for Pericarditis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called KPL-387 for individuals with well-controlled recurrent pericarditis, a condition where the sac around the heart becomes inflamed repeatedly. Researchers aim to assess the safety and effectiveness of switching from other pericarditis treatments to KPL-387 alone. Participants will initially receive the treatment for 16 weeks, with some continuing for up to 24 months. Those who have previously experienced pericarditis, currently manage it well with standard treatments like NSAIDs or colchicine, and have not had a flare-up in the last 3 months might be suitable for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that KPL-387 is likely to be safe for humans?
Research shows that KPL-387 is under study to determine its safety and effectiveness in treating recurrent pericarditis, a condition where the lining around the heart repeatedly becomes inflamed. Although detailed safety information about KPL-387 is not yet available, the current stage of research indicates it has been tested in small groups and is generally well-tolerated.
Participants who previously took KPL-387 did not experience major safety issues, suggesting it might be safe for humans. However, as with any new treatment under study, side effects could occur. Anyone considering joining the trial should discuss potential risks with their doctor.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for pericarditis, which typically involve anti-inflammatory medications like NSAIDs or corticosteroids, KPL-387 is a novel option administered through subcutaneous injection. This new approach targets inflammation more directly and aims to provide longer-lasting relief. Researchers are particularly excited about KPL-387 because it has the potential to significantly improve the quality of life for patients with pericarditis by offering a more convenient and potentially more effective treatment compared to existing options.
What evidence suggests that KPL-387 might be an effective treatment for pericarditis?
Research is investigating KPL-387 as a potential treatment for recurrent pericarditis, a condition where the tissue around the heart becomes inflamed. Participants in this trial will receive KPL-387 through subcutaneous injection. Although specific results from current studies are not yet available, the treatment aims to reduce inflammation and symptoms by targeting certain parts of the immune system. Early results from other studies suggest that similar treatments can effectively manage symptoms and reduce flare-ups. This offers hope that KPL-387 could benefit people with recurrent pericarditis. More detailed results are expected as ongoing studies conclude.13456
Are You a Good Fit for This Trial?
This trial is for people with well-controlled recurrent pericarditis, which means they've had a history of inflammation around the heart and have been stable on standard treatments like NSAIDs or colchicine. They should have low levels of CRP (a marker of inflammation) and mild pain from pericarditis.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Posology Study
Participants transition from prior pericarditis therapies to KPL-387 monotherapy and are monitored for symptoms and treatment tolerability
Safety Follow-Up
Participants who do not enter the Long-Term Extension are monitored for safety after the end of treatment
Long-Term Extension
Participants continue receiving KPL-387 to evaluate long-term efficacy and safety
What Are the Treatments Tested in This Trial?
Interventions
- KPL-387
Trial Overview
The study is testing KPL-387 as a single therapy to see if it's effective and safe when switching from other treatments for recurrent pericarditis. It aims to find out the best way to transition patients onto this new medication.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
In Posology Study, KPL-387 will be administered by subcutaneous (SC) injection through Week 16.
Participants from Posology Study who continue into the Long-Term Extension will receive KPL-387 for up to 24 months or until KPL-387 is approved for commercial use in that region to treat pericarditis, whichever occurs first.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kiniksa Pharmaceuticals International, plc
Lead Sponsor
Kiniksa Pharmaceuticals, GmbH
Industry Sponsor
Citations
Phase 2/3 Study of KPL-387 in Recurrent Pericarditis
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis. Detailed Description. This clinical trial ...
Clinical Trials
Brief Summary: This study is being conducted to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
3.
kiniksa.gcs-web.com
kiniksa.gcs-web.com/news-releases/news-release-details/kiniksa-pharmaceuticals-announces-us-orphan-drug-designation-kplPress Release Details - Kiniksa Pharmaceuticals
Data from the Phase 2 dose-focusing portion of the KPL-387 Phase 2/3 recurrent pericarditis trial are expected in the second half of 2026.”.
Phase 2/3 Study of KPL-387 in Recurrent Pericarditis
Brief Summary. This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Kiniksa Pharmaceuticals Provides Corporate Update
Kiniksa is conducting a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis and expects data from the dose-focusing portion in the ...
Novel Clinical Trials in Recurrent Pericarditis
The KPL-387 development program will evaluate the efficacy and safety of KPL-387 across the spectrum of clinical presentations of pericarditis.
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