A Pilot Study of KPL-914 in Recurrent Pericarditis
- Conditions
- Recurrent Pericarditis
- Interventions
- Drug: KPL-914
- Registration Number
- NCT03980522
- Lead Sponsor
- Kiniksa Pharmaceuticals (UK), Ltd.
- Brief Summary
The purpose of this study is to assess the preliminary efficacy and safety of KPL-914 treatment in participants with recurrent pericarditis.
- Detailed Description
This is an open-label, single-arm pilot study to explore clinical and biochemical endpoints of pericarditis symptomatology and to collect data to assess inter- and intra-subject variability on both at-baseline and on-treatment parameters. This study consists of 5 distinct Parts, and all participants will be treated with once-weekly subcutaneously (SC)-administered injections of KPL-914.There is an optional 18-week extension period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KPL-914: Part 1 Participants KPL-914 Part 1 enrolls symptomatic participants with recurrent idiopathic pericarditis (RIP) with an elevated marker of systemic inflammation (C-reactive protein \[CRP\] \> 1mg/dL). KPL-914: Part 4 Participants KPL-914 Part 4 enrolls symptomatic participants with recurrent post pericardiotomy syndrome (PPS) with an elevated marker of systemic inflammation (CRP \> 1mg/dL). KPL-914: Part 2 Participants KPL-914 Part 2 enrolls symptomatic participants with RIP with CRP ≤1 mg/dL which, in the opinion of the Investigator, can be attributed to concomitant medications (e.g., corticosteroids) and with pericardial inflammation present on cardiac magnetic resonance imaging (MRI) confirmed by the imaging core lab. KPL-914: Part 3 Participants KPL-914 Part 3 enrolls participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis. KPL-914: Part 5 Participants KPL-914 Part 5 enrolls participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis.
- Primary Outcome Measures
Name Time Method Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores Baseline, Treatment Period (TP) Day 3, Weeks 2, 3, TP Interval Evaluation (between Weeks 3-4), 4, 5, 6, End of TP (up to Week 6), Extension Period (EP): Months 1, 2, 3, 4, EP Interval Evaluation (between Weeks 15-20), Final Visit (up to Week 25) The average level of pericarditis pain over previous 24 hours was assessed by participants at each visit using 11-point pain NRS (where "0" indicates "no pain" and "10" indicates pain "as bad as it could be").
Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels Screening Visit 1 (Day -3 to Day 0), Screening Visit 2 (Day -3 to Day 0), Day 0, Baseline (defined as the last non-missing assessment prior to the first study drug administration) Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels Baseline, Treatment Period (TP) Weeks 2, 3, 4, 5, 6, TP Interval Evaluation (between Weeks 3-4), End of TP (up to Week 6), Extension Period (EP): Months 1, 2, 3, 4, EP Interval Evaluation (between Weeks 15-20), Final Visit (up to Week 25) Parts 1, 2 and 4: Pretreatment Pain NRS Scores Prescreening, Screening Visit 1 (Day -3 to Day 0), Screening Visit 2 (Day -3 to Day 0), Day 0, Baseline (defined as the last non-missing assessment prior to the first study drug administration) The average level of pericarditis pain over previous 24 hours was assessed by participants at each visit using 11-point pain NRS (where "0" indicates "no pain" and "10" indicates pain "as bad as it could be").
Parts 3 and 5: Change From Baseline Over Time in CRP Levels Baseline, TP Weeks 2, 3, Interval Evaluation Visit (Weeks 3-4), 4, 5, 6, End of TP Visit (Week 6), EP Months 1, 2, 3, 4, EP Interval Evaluation Visit (Week 15-Week 20), Final Visit (up to EP Month 4) Baseline is defined as the last non-missing assessment prior to the first study drug administration.
Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores Baseline, TP Day 3, TP Weeks 2, 3, Interval Evaluation Visit (Weeks 3-4), 4, 5, 6, End of TP Visit (Week 6), EP Months 1, 2, 3, 4, EP Interval Evaluation Visit (Week 15-Week 20), Final Visit (up to EP Month 4) The average level of pericarditis pain over previous 24 hours was assessed by participants at each visit using 11-point pain NRS (where "0" indicates "no pain" and "10" indicates pain "as bad as it could be"). Baseline is defined as the last non-missing assessment prior to the first study drug administration.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Research Integrity, LLC
🇺🇸Owensboro, Kentucky, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Franciscan Physician Network Indiana Heart Physicians Cardiovascular Research Program
🇺🇸Indianapolis, Indiana, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Affinity Clinical Research Institute
🇺🇸Oak Brook, Illinois, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Ellipsis Research Group
🇺🇸Brooklyn, New York, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
BI Research Center
🇺🇸Houston, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States