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The purpose of this study is to assess the preliminary efficacy and safety of KPL-914 treatment in participants with recurrent pericarditis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KPL-914: Part 1 Participants | Experimental | 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 2 Participants | Experimental | 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. |
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| KPL-914: Part 3 Participants | Experimental | Part 3 enrolls participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis. |
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| KPL-914: Part 4 Participants | Experimental | Part 4 enrolls symptomatic participants with recurrent post pericardiotomy syndrome (PPS) with an elevated marker of systemic inflammation (CRP > 1mg/dL). |
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| KPL-914: Part 5 Participants | Experimental | Part 5 enrolls participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KPL-914 | Drug | KPL-914 (rilonacept) will be provided in its commercially available formulation as a lyophilized powder to be reconstituted for SC administration. Adult participants (≥ 18 years of age) KPL-914 will be administered as an initial loading dose of 320 mg SC, delivered as 2 subcutaneous injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Pediatric participants (6 to <18 years of age) KPL-914 will be administered with an initial loading dose of 4.4 mg/kg, up to a maximum of 320 mg, delivered as 2 subcutaneous injections of 2.2 mg/kg each with a maximum single-injection volume of 2 mL. Participants considered to be 'treatment responders' will be offered participation in an optional 18-week extension period (EP) in which KPL-914 can be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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"). | 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) |
| Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | 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, 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) |
| Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Baseline is defined as the last non-missing assessment prior to the first study drug administration. | 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) |
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Inclusion Criteria for All Participants:
Parts 1, 2 and 4:
Subjects eligible for Parts 1, 2 and 4 have to present during a symptomatic episode of recurrent idiopathic pericarditis (RIP; Parts 1 and 2) and post pericardiotomy syndrome (PPS; Part 4) and a history of at least one pericarditis recurrence. They can be enrolled into Part 1 or 4 if the CRP value at screening is >1 mg/dL, and into Part 2 if a CRP ≤1 mg/dL (attributed to concomitant medications e.g., corticosteroids), and there is an evidence of pericardial inflammation on cardiac MRI confirmed by the imaging core lab.
Enrollment into Part 3 and 5:
Subjects eligible for Part 3 of this study have to present with corticosteroid-dependent RIP or PPS and history of at least 2 pericarditis recurrences.
Exclusion Criteria for All Participants:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Operations Study Director | Kiniksa Pharmaceuticals (UK), Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Avail Clinical Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33229362 | Result | Klein AL, Lin D, Cremer PC, Nasir S, Luis SA, Abbate A, Ertel A, LeWinter M, Beutler A, Fang F, Paolini JF. Efficacy and safety of rilonacept for recurrent pericarditis: results from a phase II clinical trial. Heart. 2020 Nov 23;107(6):488-96. doi: 10.1136/heartjnl-2020-317928. Online ahead of print. | |
| 33882846 | Derived |
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Overall, 26 participants were enrolled in the study; however, only 25 unique participants were included in the analyses, as one participant was enrolled a second time.
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| ID | Title | Description |
|---|---|---|
| FG000 | KPL-914: Part 1 Participants | Symptomatic participants with recurrent idiopathic pericarditis (RIP) with an elevated marker of systemic inflammation (C-reactive protein [CRP] > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg subcutaneous (SC), delivered as 2 subcutaneous (SC) injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week extension period (EP) in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 19, 2019 | Apr 5, 2021 |
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|
|
| Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | 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. | 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) |
| DeLand |
| Florida |
| 32720 |
| United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Affinity Clinical Research Institute | Oak Brook | Illinois | 60523 | United States |
| Franciscan Physician Network Indiana Heart Physicians Cardiovascular Research Program | Indianapolis | Indiana | 46237 | United States |
| Research Integrity, LLC | Owensboro | Kentucky | 42303 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Ellipsis Research Group | Brooklyn | New York | 11215 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| BI Research Center | Houston | Texas | 77084 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Lin D, Klein A, Cella D, Beutler A, Fang F, Magestro M, Cremer P, LeWinter MM, Luis SA, Abbate A, Ertel A, Litcher-Kelly L, Klooster B, Paolini JF. Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept. BMC Cardiovasc Disord. 2021 Apr 21;21(1):201. doi: 10.1186/s12872-021-02008-3. |
| FG001 | KPL-914: Part 2 Participants | 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 received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
| FG002 | KPL-914: Part 3 Participants | Participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
| FG003 | KPL-914: Part 4 Participants | Symptomatic participants with recurrent post pericardiotomy syndrome (PPS) with an elevated marker of systemic inflammation (CRP > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
| FG004 | KPL-914: Part 5 Participants | Participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| Extension Period |
|
Safety Population: all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | KPL-914: Part 1 Participants | Symptomatic participants with RIP with an elevated marker of systemic inflammation (CRP > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
| BG001 | KPL-914: Part 2 Participants | 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 MRI confirmed by the imaging core lab received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
| BG002 | KPL-914: Part 3 Participants | Participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
| BG003 | KPL-914: Part 4 Participants | Symptomatic participants with recurrent PPS with an elevated marker of systemic inflammation (CRP > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
| BG004 | KPL-914: Part 5 Participants | Participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Pain Rating Scale Score | Average level of pericarditis pain over previous 24 hours was assessed by participants at Baseline using 11-point pain Numerical Rating Scale (NRS), where "0" indicates "no pain" and "10" indicates pain "as bad as it could be." | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | Modified Intent-to-Treat (mITT) Population: all participants who received at least one dose of study drug. Participants with an assessment at given time point. | Posted | Mean | Standard Deviation | mg/dL | 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) |
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| Primary | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Modified Intent-to-Treat (mITT) Population: all participants who received at least one dose of study drug. Participants with an assessment at given time point. | Posted | Mean | Standard Deviation | mg/dL | 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) |
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| Primary | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | 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"). | Modified Intent-to-Treat (mITT) Population: all participants who received at least one dose of study drug. Participants with an assessment at given time point. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Primary | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | 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"). | Modified Intent-to-Treat (mITT) Population: all participants who received at least one dose of study drug. Participants with an assessment at given time point. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Primary | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Baseline is defined as the last non-missing assessment prior to the first study drug administration. | Modified Intent-to-Treat (mITT) Population: all participants who received at least one dose of study drug. Participants with an assessment at given time point. | Posted | Mean | Standard Deviation | mg/dL | 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) |
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| Primary | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | 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. | Modified Intent-to-Treat (mITT) Population: all participants who received at least one dose of study drug. Participants with an assessment at given time point. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
From first dose of study drug up to 25 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KPL-914: Part 1 Participants | Symptomatic participants with RIP with an elevated marker of systemic inflammation (CRP > 1 mg/dL) receivedKPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. | 0 | 12 | 2 | 12 | 12 | 12 |
| EG001 | KPL-914: Part 2 Participants | 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 MRI confirmed by the imaging core lab received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | KPL-914: Part 3 Participants | Participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | KPL-914: Part 4 Participants | Symptomatic participants with recurrent post pericardiotomy syndrome (PPS) with an elevated marker of systemic inflammation (CRP > 1mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG004 | KPL-914: Part 5 Participants | Participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. | 0 | 3 | 0 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Application site bruise | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Injection site joint warmth | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ulcer haemorrhage | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| High density lipoprotein increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Lipids increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac discomfort | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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Sponsor has the first right to publish information obtained from the trial. After Sponsor publishes, PI may publish its own trial results, provided that Sponsor may embargo such publication for up to 60 days for purposes of identifying confidential information (other than trial data) that must be removed and up to an additional 90 days to prepare a patent application if there is patentable subject matter in the PI's proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations Study Director | Kiniksa Pharmaceuticals (UK), Ltd. c/o Kiniksa Pharmaceuticals Corp. | 1-781-431-9100 | studyinfo@kiniksa.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 4, 2019 | Apr 2, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010493 | Pericarditis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C531377 | rilonacept |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| White |
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| Screening Visit 2 |
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| Day 0 |
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| Baseline |
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Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint. Estimates of inter-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used. |
| Inter-subject variance |
| 0.0018 |
| 2-Sided |
| Other |
| Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint. Estimates of inter-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used. | Inter-subject variance | 0.0000 | 2-Sided | Other |
| Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint. Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used. | Intra-subject variance | 12.6852 | 2-Sided | Other |
| Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint. Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used. | Intra-subject variance | 0.1842 | 2-Sided | Other |
| Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint. Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used. | Intra-subject variance | 1.0000 | 2-Sided | Other |
| OG002 | KPL-914: Part 4 Participants | Symptomatic participants with recurrent PPS with an elevated marker of systemic inflammation (CRP > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
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| OG002 | KPL-914: Part 4 Participants | Symptomatic participants with recurrent PPS with an elevated marker of systemic inflammation (CRP > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
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| OG002 | KPL-914: Part 4 Participants | Symptomatic participants with recurrent PPS with an elevated marker of systemic inflammation (CRP > 1 mg/dL) received KPL-914, administered as an initial loading dose of 320 mg SC, delivered as 2 SC injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Participants considered to be 'treatment responders' were offered participation in an optional 18-week EP in which KPL-914 could be continued for a total duration of KPL-914 treatment of up to 24 weeks. |
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