Recurrent Pericarditis
Conditions
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.
Interventions
DRUGKPL-914
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.
Sponsors
Kiniksa Pharmaceuticals (UK), Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
for All Participants: * Has given consent (or assent, if applicable) and signed an Informed Consent Form (ICF) (or informed assent form, if applicable). * Male or female, of any ethnic origin. * 6 to 75 years of age, inclusive. * If used, has received non-steroidal anti-inflammatory drugs (NSAIDs), and/or colchicine and/or corticosteroids (in any combination) at stable dose levels for at least 7 days prior to study drug dosing (although stable doses for a shorter period will be acceptable if in the opinion of the Investigator, in consultation with the Sponsor, a shorter period of stability is not anticipated to alter the baseline CRP values) and is anticipated to continue these concomitant medications at these dose levels for the duration of the active Treatment Period. * If female of child-bearing potential, must be nonpregnant and nonlactating and must agree to use an effective method of contraception, e.g., hormonal contraception or double-barrier birth control. * Is able to adequately maintain a medication diary. * Agrees to refrain from making any new, major life-style changes that may affect pericarditis symptoms (e.g., starting a new diet or changing exercise pattern) from the time of signature of the ICF (or informed assent form, if applicable) to the End-of-Trial Visit. 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: * Has a diagnosis of pericarditis that was secondary to specific excluded etiologies, including tuberculous, neoplastic, or purulent etiologies, post-myocardial infarction (early or late), thoracic trauma, myocarditis, or systemic diseases including autoinflammatory diseases, autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.). * Has a history of immunodepression, including a positive human immunodeficiency virus test result. * Has received treatment within the 6-month period before dosing with any systemic immunosuppressants (other than, for example, corticosteroids or mycophenolate) which, in the opinion of the Investigator (in consultation with the Sponsor), may interfere with the study endpoints. * Currently receiving other interleukin (IL)-1 or IL-6 blockers, Janus-activating kinase (JAK) or tumor necrosis factor (TNF) inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 3 |
| 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. | 6 |
| 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. | 1 |
| 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. | 3 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Treatment Period | Adverse Event | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | KPL-914: Part 5 Participants | KPL-914: Part 4 Participants | KPL-914: Part 3 Participants | KPL-914: Part 2 Participants | KPL-914: Part 1 Participants |
|---|---|---|---|---|---|---|
| Age, Continuous | 42.8 years STANDARD_DEVIATION 10.51 | 42.0 years STANDARD_DEVIATION 7.21 | 34.0 years | 51.3 years STANDARD_DEVIATION 7.84 | 42.7 years STANDARD_DEVIATION 15.01 | 39.6 years STANDARD_DEVIATION 10.23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 3 Participants | 1 Participants | 6 Participants | 3 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Pain Rating Scale Score | 3.4 units on a scale STANDARD_DEVIATION 2.27 | 2.0 units on a scale STANDARD_DEVIATION 2.65 | 4.0 units on a scale | 1.2 units on a scale STANDARD_DEVIATION 0.75 | 4.7 units on a scale STANDARD_DEVIATION 3.06 | 4.6 units on a scale STANDARD_DEVIATION 1.68 |
| Race/Ethnicity, Customized Black/African American | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 3 Participants | 1 Participants | 6 Participants | 2 Participants | 10 Participants |
| Sex: Female, Male Female | 15 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 10 Participants | 2 Participants | 1 Participants | 4 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 3 | 0 / 6 | 0 / 1 | 0 / 3 |
| other Total, other adverse events | 12 / 12 | 3 / 3 | 6 / 6 | 1 / 1 | 3 / 3 |
| serious Total, serious adverse events | 2 / 12 | 0 / 3 | 0 / 6 | 0 / 1 | 0 / 3 |
Outcome results
Primary
Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Month 3 | -5.518 mg/dL | Standard Deviation 7.6716 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 6 | -3.805 mg/dL | Standard Deviation 4.742 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Interval Evaluation Visit | -6.937 mg/dL | Standard Deviation 7.2968 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Month 2 | -3.482 mg/dL | Standard Deviation 3.8944 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at End of TP | -3.987 mg/dL | Standard Deviation 5.8107 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 2 | -5.202 mg/dL | Standard Deviation 6.0296 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Month 1 | -5.157 mg/dL | Standard Deviation 6.3116 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 3 | -4.658 mg/dL | Standard Deviation 5.8115 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 4 | -2.213 mg/dL | Standard Deviation 2.8854 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Final Visit | -5.035 mg/dL | Standard Deviation 6.043 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Month 4 | -5.267 mg/dL | Standard Deviation 6.3316 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 5 | -5.091 mg/dL | Standard Deviation 5.9903 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Interval Evaluation Visit | -7.336 mg/dL | Standard Deviation 6.5875 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at End of TP | -0.040 mg/dL | — |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 2 | -0.277 mg/dL | Standard Deviation 0.2538 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 3 | -0.310 mg/dL | Standard Deviation 0.4246 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Interval Evaluation Visit | -0.090 mg/dL | — |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 4 | -0.445 mg/dL | Standard Deviation 0.5445 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 5 | -0.183 mg/dL | Standard Deviation 0.2656 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 6 | 0.090 mg/dL | Standard Deviation 0.2121 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Month 1 | -0.127 mg/dL | Standard Deviation 0.398 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Month 2 | -0.230 mg/dL | Standard Deviation 0.4973 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Month 3 | -0.160 mg/dL | Standard Deviation 0.3122 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Month 4 | -0.150 mg/dL | Standard Deviation 0.3995 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Final Visit | -0.137 mg/dL | Standard Deviation 0.3384 |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Month 2 | -1.080 mg/dL | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 5 | -1.090 mg/dL | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 2 | -1.040 mg/dL | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Month 3 | -1.080 mg/dL | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 4 | -1.110 mg/dL | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Final Visit | -1.090 mg/dL | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at End of TP | -0.610 mg/dL | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Month 4 | -1.070 mg/dL | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at EP Month 1 | -1.110 mg/dL | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 6 | -1.060 mg/dL | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in CRP Levels | Change at TP Week 3 | -1.110 mg/dL | — |
Comparison: 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 change from baseline in 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 post-baseline visits was used.
Comparison: 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 change from baseline in 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 post-baseline visits was used.
Comparison: 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 change from baseline in 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 post-baseline visits was used.
Comparison: 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 change from baseline in 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 post-baseline visits was used.
Comparison: 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 change from baseline in 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 post-baseline visits was used.
Comparison: 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 change from baseline in 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 post-baseline visits was used.
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).
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 5 | -3.1 score on a scale | Standard Deviation 2.91 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 4 | -3.7 score on a scale | Standard Deviation 1.6 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Interval Evaluation Visit | -5.0 score on a scale | Standard Deviation 1.79 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 6 | -3.9 score on a scale | Standard Deviation 2.09 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Final Visit | -4.0 score on a scale | Standard Deviation 1.48 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 3 | -2.6 score on a scale | Standard Deviation 1.88 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at End of TP | -3.6 score on a scale | Standard Deviation 1.85 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 3 | -4.4 score on a scale | Standard Deviation 1.4 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Day 3 | -1.7 score on a scale | Standard Deviation 2.5 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 1 | -4.1 score on a scale | Standard Deviation 1.52 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 4 | -4.2 score on a scale | Standard Deviation 1.4 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 2 | -3.3 score on a scale | Standard Deviation 1.48 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 2 | -3.6 score on a scale | Standard Deviation 2.12 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Interval Evaluation Visit | -3.8 score on a scale | Standard Deviation 2.04 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 2 | -1.7 score on a scale | Standard Deviation 1.15 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 3 | -3.7 score on a scale | Standard Deviation 1.53 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Interval Evaluation Visit | -2.0 score on a scale | — |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 4 | -4.7 score on a scale | Standard Deviation 3.06 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Final Visit | -4.7 score on a scale | Standard Deviation 3.06 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 4 | -1.0 score on a scale | Standard Deviation 0 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 2 | -3.7 score on a scale | Standard Deviation 1.53 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 5 | -2.0 score on a scale | Standard Deviation 1 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Day 3 | -0.3 score on a scale | Standard Deviation 0.58 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 6 | -5.0 score on a scale | Standard Deviation 4.24 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at End of TP | -3.0 score on a scale | Standard Deviation 1.41 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 3 | -1.0 score on a scale | Standard Deviation 0 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 1 | -2.0 score on a scale | Standard Deviation 2 |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Final Visit | -4.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Day 3 | -3.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 2 | -4.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 3 | -4.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 4 | -4.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 5 | -4.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 6 | -4.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at End of TP | -4.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 1 | -4.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 2 | -4.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 3 | -4.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 4 | -4.0 score on a scale | — |
Comparison: Inter-subject variability of NRS Scores 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 change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used.
Comparison: Inter-subject variability of NRS Scores 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 change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used.
Comparison: Inter-subject variability of NRS Scores 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 change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used.
Comparison: Intra-subject variability of NRS Scores 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 change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used.
Comparison: Intra-subject variability of NRS Scores 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 change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used.
Comparison: Intra-subject variability of NRS Scores 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 change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used.
Primary
Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | Screening Visit 1 | 5.921 mg/dL | Standard Deviation 5.3423 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | Baseline | 4.907 mg/dL | Standard Deviation 5.7686 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | Screening Visit 2 | 4.455 mg/dL | Standard Deviation 0.4455 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | Day 0 | 5.156 mg/dL | Standard Deviation 6.415 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | Day 0 | 0.090 mg/dL | — |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | Screening Visit 1 | 0.645 mg/dL | Standard Deviation 0.4313 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | Baseline | 0.460 mg/dL | Standard Deviation 0.4424 |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | Baseline | 1.140 mg/dL | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels | Day 0 | 1.140 mg/dL | — |
Comparison: Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and standard deviation (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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
Comparison: 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.
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).
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Baseline | 4.6 score on a scale | Standard Deviation 1.68 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Screening Visit 2 | 4.8 score on a scale | Standard Deviation 2.23 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Screening Visit 1 | 4.3 score on a scale | Standard Deviation 2.09 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Day 0 | 4.5 score on a scale | Standard Deviation 1 |
| KPL-914: Part 1 Participants | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Prescreening | 3.0 score on a scale | Standard Deviation 1.41 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Baseline | 4.7 score on a scale | Standard Deviation 3.06 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Prescreening | 4.5 score on a scale | Standard Deviation 3.54 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Screening Visit 1 | 6.0 score on a scale | Standard Deviation 2.83 |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Screening Visit 2 | 4.0 score on a scale | — |
| KPL-914: Part 2 Participants | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Day 0 | 2.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Screening Visit 1 | 4.0 score on a scale | — |
| KPL-914: Part 4 Participants | Parts 1, 2 and 4: Pretreatment Pain NRS Scores | Baseline | 4.0 score on a scale | — |
Comparison: Inter-subject variability of NRS Scores 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 NRS 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.
Comparison: Inter-subject variability of NRS Scores 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 NRS 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.
Comparison: Inter-subject variability of NRS Scores 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 NRS 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.
Comparison: Intra-subject variability of NRS Scores 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 NRS 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.
Comparison: Intra-subject variability of NRS Scores 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 NRS 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.
Comparison: Intra-subject variability of NRS Scores 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 NRS 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.
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at Interval Evaluation Visit | -0.183 mg/dL | Standard Deviation 0.1002 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at End of TP Visit | -0.140 mg/dL | Standard Deviation 0.0822 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Baseline | 0.232 mg/dL | Standard Deviation 0.0975 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at TP Week 4 | -0.130 mg/dL | Standard Deviation 0.0889 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at EP Month 2 | -0.124 mg/dL | Standard Deviation 0.1717 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at TP Week 3 | -0.150 mg/dL | Standard Deviation 0.1158 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at EP Month 3 | -0.050 mg/dL | Standard Deviation 0.0566 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at TP Week 5 | -0.147 mg/dL | Standard Deviation 0.0662 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at EP Month 4 | -0.130 mg/dL | Standard Deviation 0.1147 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at TP Week 2 | -0.152 mg/dL | Standard Deviation 0.0857 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at EP Interval Evaluation Visit | -0.160 mg/dL | Standard Deviation 0.0854 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at TP Week 6 | -0.087 mg/dL | Standard Deviation 0.1861 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at Final Visit | -0.098 mg/dL | Standard Deviation 0.0841 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at EP Month 1 | -0.116 mg/dL | Standard Deviation 0.1753 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at Final Visit | -0.033 mg/dL | Standard Deviation 0.0586 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Baseline | 0.097 mg/dL | Standard Deviation 0.0503 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at TP Week 2 | -0.070 mg/dL | Standard Deviation 0.0424 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at TP Week 3 | -0.053 mg/dL | Standard Deviation 0.0404 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at Interval Evaluation Visit | -0.100 mg/dL | — |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at TP Week 4 | -0.030 mg/dL | Standard Deviation 0 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at TP Week 5 | -0.057 mg/dL | Standard Deviation 0.0462 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at TP Week 6 | 0.540 mg/dL | Standard Deviation 0.7212 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at End of TP Visit | 0.003 mg/dL | Standard Deviation 0.1305 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at EP Month 1 | -0.075 mg/dL | Standard Deviation 0.0778 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at EP Month 2 | -0.007 mg/dL | Standard Deviation 0.1206 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at EP Month 3 | 0.850 mg/dL | Standard Deviation 1.2162 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at EP Month 4 | 0.030 mg/dL | Standard Deviation 0.0656 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in CRP Levels | Change at EP Interval Evaluation Visit | -0.100 mg/dL | — |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at Interval Evaluation Visit (Weeks 3-4) | 0.0 score on a scale | Standard Deviation 1 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at End of TP Visit (Week 6) | 0.0 score on a scale | Standard Deviation 0 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at TP Day 3 | 0.0 score on a scale | Standard Deviation 0.89 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 1 | -1.0 score on a scale | Standard Deviation 0.71 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 4 | 0.7 score on a scale | Standard Deviation 1.15 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 2 | -1.0 score on a scale | Standard Deviation 0.71 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 3 | 0.3 score on a scale | Standard Deviation 1.37 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 3 | 0.0 score on a scale | Standard Deviation 0 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 5 | -0.3 score on a scale | Standard Deviation 0.82 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 4 | -0.4 score on a scale | Standard Deviation 1.52 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 2 | 0.5 score on a scale | Standard Deviation 1.64 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at EP Interval Evaluation Visit (Week 15-Week 20) | -1.3 score on a scale | Standard Deviation 0.58 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 6 | -0.7 score on a scale | Standard Deviation 0.52 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at Final Visit | -0.6 score on a scale | Standard Deviation 1.14 |
| KPL-914: Part 1 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Baseline | 1.2 score on a scale | Standard Deviation 0.75 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at Final Visit | -1.0 score on a scale | Standard Deviation 1 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Baseline | 2.0 score on a scale | Standard Deviation 2.65 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at TP Day 3 | 0.0 score on a scale | Standard Deviation 0 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 2 | -0.5 score on a scale | Standard Deviation 0.71 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 3 | -0.5 score on a scale | Standard Deviation 0.71 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at Interval Evaluation Visit (Weeks 3-4) | -1.0 score on a scale | — |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 4 | 0.0 score on a scale | — |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 5 | 0.0 score on a scale | Standard Deviation 0 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at TP Week 6 | -0.7 score on a scale | Standard Deviation 0.58 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at End of TP Visit (Week 6) | -2.5 score on a scale | Standard Deviation 3.54 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 1 | -1.0 score on a scale | Standard Deviation 1 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 2 | -1.0 score on a scale | Standard Deviation 1 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 3 | -1.0 score on a scale | Standard Deviation 1.41 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at EP Month 4 | -1.0 score on a scale | Standard Deviation 1 |
| KPL-914: Part 2 Participants | Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores | Change at EP Interval Evaluation Visit (Week 15-Week 20) | -1.0 score on a scale | — |