Trial Outcomes & Findings for A Pilot Study of KPL-914 in Recurrent Pericarditis (NCT NCT03980522)
NCT ID: NCT03980522
Last Updated: 2021-05-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
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)
Results posted on
2021-05-27
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Treatment Period
STARTED
|
13
|
3
|
6
|
1
|
3
|
|
Treatment Period
COMPLETED
|
12
|
3
|
6
|
1
|
3
|
|
Treatment Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
|
Extension Period
STARTED
|
12
|
3
|
5
|
1
|
3
|
|
Extension Period
COMPLETED
|
12
|
3
|
5
|
1
|
3
|
|
Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|
|
Treatment Period
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Pilot Study of KPL-914 in Recurrent Pericarditis
Baseline characteristics by cohort
| Measure |
KPL-914: Part 1 Participants
n=12 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.
|
KPL-914: Part 2 Participants
n=3 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.
|
KPL-914: Part 3 Participants
n=6 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.
|
KPL-914: Part 4 Participants
n=1 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.
|
KPL-914: Part 5 Participants
n=3 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.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 10.23 • n=99 Participants
|
42.7 years
STANDARD_DEVIATION 15.01 • n=107 Participants
|
51.3 years
STANDARD_DEVIATION 7.84 • n=206 Participants
|
34.0 years
STANDARD_DEVIATION NA • n=157 Participants
|
42.0 years
STANDARD_DEVIATION 7.21 • n=390 Participants
|
42.8 years
STANDARD_DEVIATION 10.51 • n=16 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
15 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
10 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
25 Participants
n=16 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
3 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
22 Participants
n=16 Participants
|
|
Pain Rating Scale Score
|
4.6 units on a scale
STANDARD_DEVIATION 1.68 • n=99 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 3.06 • n=107 Participants
|
1.2 units on a scale
STANDARD_DEVIATION 0.75 • n=206 Participants
|
4.0 units on a scale
STANDARD_DEVIATION NA • n=157 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 2.65 • n=390 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 2.27 • n=16 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
KPL-914: Part 1 Participants
n=12 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.
|
KPL-914: Part 2 Participants
n=3 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.
|
KPL-914: Part 4 Participants
n=1 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.
|
|---|---|---|---|
|
Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels
Screening Visit 1
|
5.921 mg/dL
Standard Deviation 5.3423
|
0.645 mg/dL
Standard Deviation 0.4313
|
—
|
|
Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels
Screening Visit 2
|
4.455 mg/dL
Standard Deviation 0.4455
|
—
|
—
|
|
Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels
Day 0
|
5.156 mg/dL
Standard Deviation 6.4150
|
0.090 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
1.140 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
|
Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels
Baseline
|
4.907 mg/dL
Standard Deviation 5.7686
|
0.460 mg/dL
Standard Deviation 0.4424
|
1.140 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
KPL-914: Part 1 Participants
n=12 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.
|
KPL-914: Part 2 Participants
n=3 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.
|
KPL-914: Part 4 Participants
n=1 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.
|
|---|---|---|---|
|
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
|
-0.277 mg/dL
Standard Deviation 0.2538
|
-1.040 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-0.310 mg/dL
Standard Deviation 0.4246
|
-1.110 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-0.090 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
—
|
|
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
|
-0.445 mg/dL
Standard Deviation 0.5445
|
-1.110 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-0.183 mg/dL
Standard Deviation 0.2656
|
-1.090 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
|
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 4.7420
|
0.090 mg/dL
Standard Deviation 0.2121
|
-1.060 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-0.040 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
-0.610 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-0.127 mg/dL
Standard Deviation 0.3980
|
-1.110 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-0.230 mg/dL
Standard Deviation 0.4973
|
-1.080 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-0.160 mg/dL
Standard Deviation 0.3122
|
-1.080 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-0.150 mg/dL
Standard Deviation 0.3995
|
-1.070 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
—
|
—
|
|
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 6.0430
|
-0.137 mg/dL
Standard Deviation 0.3384
|
-1.090 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
PRIMARY outcome
Timeframe: 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.
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").
Outcome measures
| Measure |
KPL-914: Part 1 Participants
n=12 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.
|
KPL-914: Part 2 Participants
n=3 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.
|
KPL-914: Part 4 Participants
n=1 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.
|
|---|---|---|---|
|
Parts 1, 2 and 4: Pretreatment Pain NRS Scores
Prescreening
|
3.0 score on a scale
Standard Deviation 1.41
|
4.5 score on a scale
Standard Deviation 3.54
|
—
|
|
Parts 1, 2 and 4: Pretreatment Pain NRS Scores
Screening Visit 1
|
4.3 score on a scale
Standard Deviation 2.09
|
6.0 score on a scale
Standard Deviation 2.83
|
4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
Parts 1, 2 and 4: Pretreatment Pain NRS Scores
Screening Visit 2
|
4.8 score on a scale
Standard Deviation 2.23
|
4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
—
|
|
Parts 1, 2 and 4: Pretreatment Pain NRS Scores
Day 0
|
4.5 score on a scale
Standard Deviation 1.00
|
2.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
—
|
|
Parts 1, 2 and 4: Pretreatment Pain NRS Scores
Baseline
|
4.6 score on a scale
Standard Deviation 1.68
|
4.7 score on a scale
Standard Deviation 3.06
|
4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
PRIMARY outcome
Timeframe: 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.
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").
Outcome measures
| Measure |
KPL-914: Part 1 Participants
n=12 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.
|
KPL-914: Part 2 Participants
n=3 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.
|
KPL-914: Part 4 Participants
n=1 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.
|
|---|---|---|---|
|
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 2.50
|
-0.3 score on a scale
Standard Deviation 0.58
|
-3.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-1.7 score on a scale
Standard Deviation 1.15
|
-4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-1.0 score on a scale
Standard Deviation 0.00
|
-4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-2.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
—
|
|
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 1.60
|
-1.0 score on a scale
Standard Deviation 0.00
|
-4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-2.0 score on a scale
Standard Deviation 1.00
|
-4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-5.0 score on a scale
Standard Deviation 4.24
|
-4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-4.7 score on a scale
Standard Deviation 3.06
|
-4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-3.0 score on a scale
Standard Deviation 1.41
|
-4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-2.0 score on a scale
Standard Deviation 2.00
|
-4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
-3.7 score on a scale
Standard Deviation 1.53
|
-4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
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 1.40
|
-3.7 score on a scale
Standard Deviation 1.53
|
-4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
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 1.40
|
-4.7 score on a scale
Standard Deviation 3.06
|
-4.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point
|
|
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
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Baseline is defined as the last non-missing assessment prior to the first study drug administration.
Outcome measures
| Measure |
KPL-914: Part 1 Participants
n=6 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.
|
KPL-914: Part 2 Participants
n=3 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.
|
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.
|
|---|---|---|---|
|
Parts 3 and 5: Change From Baseline Over Time in CRP Levels
Baseline
|
0.232 mg/dL
Standard Deviation 0.0975
|
0.097 mg/dL
Standard Deviation 0.0503
|
—
|
|
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
|
-0.070 mg/dL
Standard Deviation 0.0424
|
—
|
|
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
|
-0.053 mg/dL
Standard Deviation 0.0404
|
—
|
|
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
|
-0.100 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
—
|
|
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
|
-0.030 mg/dL
Standard Deviation 0.0000
|
—
|
|
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
|
-0.057 mg/dL
Standard Deviation 0.0462
|
—
|
|
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
|
0.540 mg/dL
Standard Deviation 0.7212
|
—
|
|
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
|
0.003 mg/dL
Standard Deviation 0.1305
|
—
|
|
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
|
-0.075 mg/dL
Standard Deviation 0.0778
|
—
|
|
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
|
-0.007 mg/dL
Standard Deviation 0.1206
|
—
|
|
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
|
0.850 mg/dL
Standard Deviation 1.2162
|
—
|
|
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
|
0.030 mg/dL
Standard Deviation 0.0656
|
—
|
|
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
|
-0.100 mg/dL
Standard Deviation NA
1 participant in this arm at this time point
|
—
|
|
Parts 3 and 5: Change From Baseline Over Time in CRP Levels
Change at Final Visit
|
-0.098 mg/dL
Standard Deviation 0.0841
|
-0.033 mg/dL
Standard Deviation 0.0586
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
KPL-914: Part 1 Participants
n=6 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.
|
KPL-914: Part 2 Participants
n=3 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.
|
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.
|
|---|---|---|---|
|
Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores
Baseline
|
1.2 score on a scale
Standard Deviation 0.75
|
2.0 score on a scale
Standard Deviation 2.65
|
—
|
|
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
|
0.0 score on a scale
Standard Deviation 0.00
|
—
|
|
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
|
-0.5 score on a scale
Standard Deviation 0.71
|
—
|
|
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
|
0.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point.
|
—
|
|
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
|
0.0 score on a scale
Standard Deviation 0.00
|
—
|
|
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
|
-0.7 score on a scale
Standard Deviation 0.58
|
—
|
|
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 0.00
|
-2.5 score on a scale
Standard Deviation 3.54
|
—
|
|
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
|
-1.0 score on a scale
Standard Deviation 1.00
|
—
|
|
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
|
-1.0 score on a scale
Standard Deviation 1.00
|
—
|
|
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 0.00
|
-1.0 score on a scale
Standard Deviation 1.41
|
—
|
|
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
|
-1.0 score on a scale
Standard Deviation 1.00
|
—
|
|
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
|
-1.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point.
|
—
|
|
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
|
-1.0 score on a scale
Standard Deviation 1.00
|
—
|
|
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
|
-0.5 score on a scale
Standard Deviation 0.71
|
—
|
|
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 1.00
|
-1.0 score on a scale
Standard Deviation NA
1 participant in this arm at this time point.
|
—
|
Adverse Events
KPL-914: Part 1 Participants
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
KPL-914: Part 2 Participants
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
KPL-914: Part 3 Participants
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
KPL-914: Part 4 Participants
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
KPL-914: Part 5 Participants
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KPL-914: Part 1 Participants
n=12 participants at risk
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.
|
KPL-914: Part 2 Participants
n=3 participants at risk
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.
|
KPL-914: Part 3 Participants
n=6 participants at risk
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.
|
KPL-914: Part 4 Participants
n=1 participants at risk
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.
|
KPL-914: Part 5 Participants
n=3 participants at risk
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.
|
|---|---|---|---|---|---|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Infections and infestations
Subcutaneous abscess
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
Other adverse events
| Measure |
KPL-914: Part 1 Participants
n=12 participants at risk
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.
|
KPL-914: Part 2 Participants
n=3 participants at risk
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.
|
KPL-914: Part 3 Participants
n=6 participants at risk
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.
|
KPL-914: Part 4 Participants
n=1 participants at risk
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.
|
KPL-914: Part 5 Participants
n=3 participants at risk
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.
|
|---|---|---|---|---|---|
|
General disorders
Injection site reaction
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
33.3%
2/6 • From first dose of study drug up to 25 weeks.
|
100.0%
1/1 • From first dose of study drug up to 25 weeks.
|
66.7%
2/3 • From first dose of study drug up to 25 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
33.3%
1/3 • From first dose of study drug up to 25 weeks.
|
|
General disorders
Injection site bruising
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
100.0%
1/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
General disorders
Injection site erythema
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
33.3%
1/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
General disorders
Injection site pain
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
General disorders
Peripheral swelling
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
33.3%
1/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
33.3%
1/3 • From first dose of study drug up to 25 weeks.
|
|
General disorders
Application site bruise
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
General disorders
Application site erythema
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
General disorders
Chest discomfort
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
General disorders
Injection site joint warmth
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
100.0%
1/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
33.3%
2/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
33.3%
1/3 • From first dose of study drug up to 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
33.3%
1/3 • From first dose of study drug up to 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
100.0%
1/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
3/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Infections and infestations
Cellulitis
|
16.7%
2/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
33.3%
1/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
33.3%
1/3 • From first dose of study drug up to 25 weeks.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
3/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Investigations
Blood cholesterol increased
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
100.0%
1/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Investigations
Liver function test increased
|
16.7%
2/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
100.0%
1/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Investigations
High density lipoprotein increased
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Investigations
Lipids increased
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
100.0%
1/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Investigations
Weight increased
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
100.0%
1/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
33.3%
1/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
33.3%
1/3 • From first dose of study drug up to 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
100.0%
1/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
33.3%
1/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Ear and labyrinth disorders
Vertigo positional
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
16.7%
1/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Eye disorders
Dry eye
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
8.3%
1/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
0.00%
0/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/12 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
0.00%
0/6 • From first dose of study drug up to 25 weeks.
|
100.0%
1/1 • From first dose of study drug up to 25 weeks.
|
0.00%
0/3 • From first dose of study drug up to 25 weeks.
|
Additional Information
Clinical Operations Study Director
Kiniksa Pharmaceuticals (UK), Ltd. c/o Kiniksa Pharmaceuticals Corp.
Phone: 1-781-431-9100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER