A Phase 2 interventional study of KPL-914 in Recurrent Pericarditis, sponsored by Kiniksa Pharmaceuticals (UK), Ltd.. Completed at 14 sites in United States. Open to participants aged 6 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-27.
Sponsored by Kiniksa Pharmaceuticals (UK), Ltd. · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the preliminary efficacy and safety of KPL-914 treatment in participants with recurrent pericarditis.
This is an open-label, single-arm pilot study to explore clinical and biochemical endpoints of pericarditis symptomatology and to collect data to assess inter- and intra-subject variability on both at-baseline and on-treatment parameters. This study consists of 5 distinct Parts, and all participants will be treated with once-weekly subcutaneously (SC)-administered injections of KPL-914.There is an optional 18-week extension period.
54 studies on the registry are indexed under Pericarditis; 23 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 29 interventional studies indexed under Pericarditis.
Browse Pericarditis studies →Kiniksa Pharmaceuticals (UK), Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Part 1 enrolls symptomatic participants with recurrent idiopathic pericarditis (RIP) with an elevated marker of systemic inflammation (C-reactive protein \[CRP\] \> 1mg/dL).
Drug: KPL-914
Part 2 enrolls symptomatic participants with RIP with CRP ≤1 mg/dL which, in the opinion of the Investigator, can be attributed to concomitant medications (e.g., corticosteroids) and with pericardial inflammation present on cardiac magnetic resonance imaging (MRI) confirmed by the imaging core lab.
Drug: KPL-914
Part 3 enrolls participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis.
Drug: KPL-914
Part 4 enrolls symptomatic participants with recurrent post pericardiotomy syndrome (PPS) with an elevated marker of systemic inflammation (CRP \> 1mg/dL).
Drug: KPL-914
Part 5 enrolls participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis.
Drug: KPL-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.
Also known as: rilonacept
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)
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)
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)
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)
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)
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)
| Milestone | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 3 Participants | KPL-914: Part 4 Participants | KPL-914: Part 5 Participants |
|---|---|---|---|---|---|
| Started | 13 | 3 | 6 | 1 | 3 |
| Completed | 12 | 3 | 6 | 1 | 3 |
| Not completed | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 |
| Milestone | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 3 Participants | KPL-914: Part 4 Participants | KPL-914: Part 5 Participants |
|---|---|---|---|---|---|
| Started | 12 | 3 | 5 | 1 | 3 |
| Completed | 12 | 3 | 5 | 1 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| mg/dL | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 4 Participants |
|---|---|---|---|
| Screening Visit 1 | 5.921 ± 5.3423 | 0.645 ± 0.4313 | — |
| Screening Visit 2 | 4.455 ± 0.4455 | — | — |
| Day 0 | 5.156 ± 6.4150 | 0.090 ± NA | 1.140 ± NA |
| Baseline | 4.907 ± 5.7686 | 0.460 ± 0.4424 | 1.140 ± NA |
| mg/dL | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 4 Participants |
|---|---|---|---|
| Change at TP Week 2 | -5.202 ± 6.0296 | -0.277 ± 0.2538 | -1.040 ± NA |
| Change at TP Week 3 | -4.658 ± 5.8115 | -0.310 ± 0.4246 | -1.110 ± NA |
| Change at TP Interval Evaluation Visit | -6.937 ± 7.2968 | -0.090 ± NA | — |
| Change at TP Week 4 | -2.213 ± 2.8854 | -0.445 ± 0.5445 | -1.110 ± NA |
| Change at TP Week 5 | -5.091 ± 5.9903 | -0.183 ± 0.2656 | -1.090 ± NA |
| Change at TP Week 6 | -3.805 ± 4.7420 | 0.090 ± 0.2121 | -1.060 ± NA |
| Change at End of TP | -3.987 ± 5.8107 | -0.040 ± NA | -0.610 ± NA |
| Change at EP Month 1 | -5.157 ± 6.3116 | -0.127 ± 0.3980 | -1.110 ± NA |
| Change at EP Month 2 | -3.482 ± 3.8944 | -0.230 ± 0.4973 | -1.080 ± NA |
| Change at EP Month 3 | -5.518 ± 7.6716 | -0.160 ± 0.3122 | -1.080 ± NA |
| Change at EP Month 4 | -5.267 ± 6.3316 | -0.150 ± 0.3995 | -1.070 ± NA |
| Change at EP Interval Evaluation Visit | -7.336 ± 6.5875 | — | — |
| Change at EP Final Visit | -5.035 ± 6.0430 | -0.137 ± 0.3384 | -1.090 ± NA |
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").
| score on a scale | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 4 Participants |
|---|---|---|---|
| Prescreening | 3.0 ± 1.41 | 4.5 ± 3.54 | — |
| Screening Visit 1 | 4.3 ± 2.09 | 6.0 ± 2.83 | 4.0 ± NA |
| Screening Visit 2 | 4.8 ± 2.23 | 4.0 ± NA | — |
| Day 0 | 4.5 ± 1.00 | 2.0 ± NA | — |
| Baseline | 4.6 ± 1.68 | 4.7 ± 3.06 | 4.0 ± NA |
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").
| score on a scale | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 4 Participants |
|---|---|---|---|
| Change at TP Day 3 | -1.7 ± 2.50 | -0.3 ± 0.58 | -3.0 ± NA |
| Change at TP Week 2 | -3.3 ± 1.48 | -1.7 ± 1.15 | -4.0 ± NA |
| Change at TP Week 3 | -2.6 ± 1.88 | -1.0 ± 0.00 | -4.0 ± NA |
| Change at TP Interval Evaluation Visit | -3.8 ± 2.04 | -2.0 ± NA | — |
| Change at TP Week 4 | -3.7 ± 1.60 | -1.0 ± 0.00 | -4.0 ± NA |
| Change at TP Week 5 | -3.1 ± 2.91 | -2.0 ± 1.00 | -4.0 ± NA |
| Change at TP Week 6 | -3.9 ± 2.09 | -5.0 ± 4.24 | -4.0 ± NA |
| Change at End of TP | -3.6 ± 1.85 | -3.0 ± 1.41 | -4.0 ± NA |
| Change at EP Month 1 | -4.1 ± 1.52 | -2.0 ± 2.00 | -4.0 ± NA |
| Change at EP Month 2 | -3.6 ± 2.12 | -3.7 ± 1.53 | -4.0 ± NA |
| Change at EP Month 3 | -4.4 ± 1.40 | -3.7 ± 1.53 | -4.0 ± NA |
| Change at EP Month 4 | -4.2 ± 1.40 | -4.7 ± 3.06 | -4.0 ± NA |
| Change at EP Interval Evaluation Visit | -5.0 ± 1.79 | — | — |
| Change at EP Final Visit | -4.0 ± 1.48 | -4.7 ± 3.06 | -4.0 ± NA |
Baseline is defined as the last non-missing assessment prior to the first study drug administration.
| mg/dL | KPL-914: Part 3 Participants | KPL-914: Part 5 Participants |
|---|---|---|
| Baseline | 0.232 ± 0.0975 | 0.097 ± 0.0503 |
| Change at TP Week 2 | -0.152 ± 0.0857 | -0.070 ± 0.0424 |
| Change at TP Week 3 | -0.150 ± 0.1158 | -0.053 ± 0.0404 |
| Change at Interval Evaluation Visit | -0.183 ± 0.1002 | -0.100 ± NA |
| Change at TP Week 4 | -0.130 ± 0.0889 | -0.030 ± 0.0000 |
| Change at TP Week 5 | -0.147 ± 0.0662 | -0.057 ± 0.0462 |
| Change at TP Week 6 | -0.087 ± 0.1861 | 0.540 ± 0.7212 |
| Change at End of TP Visit | -0.140 ± 0.0822 | 0.003 ± 0.1305 |
| Change at EP Month 1 | -0.116 ± 0.1753 | -0.075 ± 0.0778 |
| Change at EP Month 2 | -0.124 ± 0.1717 | -0.007 ± 0.1206 |
| Change at EP Month 3 | -0.050 ± 0.0566 | 0.850 ± 1.2162 |
| Change at EP Month 4 | -0.130 ± 0.1147 | 0.030 ± 0.0656 |
| Change at EP Interval Evaluation Visit | -0.160 ± 0.0854 | -0.100 ± NA |
| Change at Final Visit | -0.098 ± 0.0841 | -0.033 ± 0.0586 |
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.
| score on a scale | KPL-914: Part 3 Participants | KPL-914: Part 5 Participants |
|---|---|---|
| Baseline | 1.2 ± 0.75 | 2.0 ± 2.65 |
| Change at TP Day 3 | 0.0 ± 0.89 | 0.0 ± 0.00 |
| Change at TP Week 2 | 0.5 ± 1.64 | -0.5 ± 0.71 |
| Change at TP Week 3 | 0.3 ± 1.37 | -0.5 ± 0.71 |
| Change at Interval Evaluation Visit (Weeks 3-4) | 0.0 ± 1.00 | -1.0 ± NA |
| Change at TP Week 4 | 0.7 ± 1.15 | 0.0 ± NA |
| Change at TP Week 5 | -0.3 ± 0.82 | 0.0 ± 0.00 |
| Change at TP Week 6 | -0.7 ± 0.52 | -0.7 ± 0.58 |
| Change at End of TP Visit (Week 6) | 0.0 ± 0.00 | -2.5 ± 3.54 |
| Change at EP Month 1 | -1.0 ± 0.71 | -1.0 ± 1.00 |
| Change at EP Month 2 | -1.0 ± 0.71 | -1.0 ± 1.00 |
| Change at EP Month 3 | 0.0 ± 0.00 | -1.0 ± 1.41 |
| Change at EP Month 4 | -0.4 ± 1.52 | -1.0 ± 1.00 |
| Change at EP Interval Evaluation Visit (Week 15-Week 20) | -1.3 ± 0.58 | -1.0 ± NA |
| Change at Final Visit | -0.6 ± 1.14 | -1.0 ± 1.00 |
Collected over From first dose of study drug up to 25 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KPL-914: Part 1 Participants | 0/12 (0%) | 2/12 (16.7%) | 12/12 (100%) |
| KPL-914: Part 2 Participants | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| KPL-914: Part 3 Participants | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| KPL-914: Part 4 Participants | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| KPL-914: Part 5 Participants | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 3 Participants | KPL-914: Part 4 Participants | KPL-914: Part 5 Participants |
|---|---|---|---|---|---|
| Non-cardiac chest painGeneral disorders | 1/12 | 0/3 | 0/6 | 0/1 | 0/3 |
| Subcutaneous abscessInfections and infestations | 1/12 | 0/3 | 0/6 | 0/1 | 0/3 |
| Event | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 3 Participants | KPL-914: Part 4 Participants | KPL-914: Part 5 Participants |
|---|---|---|---|---|---|
| Injection site reactionGeneral disorders | 1/12 | 0/3 | 2/6 | 1/1 | 2/3 |
| Injection site bruisingGeneral disorders | 1/12 | 0/3 | 0/6 | 1/1 | 0/3 |
| Ulcer haemorrhageGeneral disorders | 0/12 | 0/3 | 0/6 | 1/1 | 0/3 |
| Neck painMusculoskeletal and connective tissue disorders | 0/12 | 0/3 | 0/6 | 1/1 | 0/3 |
| Blood creatine phosphokinase increasedInvestigations | 1/12 | 0/3 | 0/6 | 1/1 | 0/3 |
| C-reactive protein increasedInvestigations | 0/12 | 0/3 | 0/6 | 1/1 | 0/3 |
| Lipids increasedInvestigations | 0/12 | 0/3 | 0/6 | 1/1 | 0/3 |
| Weight increasedInvestigations | 0/12 | 0/3 | 0/6 | 1/1 | 0/3 |
| Skin ulcerSkin and subcutaneous tissue disorders | 0/12 | 0/3 | 0/6 | 1/1 | 0/3 |
| Increased appetiteMetabolism and nutrition disorders | 0/12 | 0/3 | 0/6 | 1/1 | 0/3 |
Safety Population: all participants who received at least 1 dose of study drug.
| Age, Continuous(years) | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 3 Participants | KPL-914: Part 4 Participants | KPL-914: Part 5 Participants | Total |
|---|---|---|---|---|---|---|
| Mean | 39.6 ± 10.23 | 42.7 ± 15.01 | 51.3 ± 7.84 | 34.0 ± NA | 42.0 ± 7.21 | 42.8 ± 10.51 |
| Sex: Female, Male(Participants) | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 3 Participants | KPL-914: Part 4 Participants | KPL-914: Part 5 Participants | Total |
|---|---|---|---|---|---|---|
| Female | 9 | 3 | 2 | 0 | 1 | 15 |
| Male | 3 | 0 | 4 | 1 | 2 | 10 |
| Ethnicity (NIH/OMB)(Participants) | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 3 Participants | KPL-914: Part 4 Participants | KPL-914: Part 5 Participants | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 12 | 3 | 6 | 1 | 3 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 3 Participants | KPL-914: Part 4 Participants | KPL-914: Part 5 Participants | Total |
|---|---|---|---|---|---|---|
| Black/African American | 2 | 1 | 0 | 0 | 0 | 3 |
| White | 10 | 2 | 6 | 1 | 3 | 22 |
| Pain Rating Scale Score(units on a scale) | KPL-914: Part 1 Participants | KPL-914: Part 2 Participants | KPL-914: Part 3 Participants | KPL-914: Part 4 Participants | KPL-914: Part 5 Participants | Total |
|---|---|---|---|---|---|---|
| Mean | 4.6 ± 1.68 | 4.7 ± 3.06 | 1.2 ± 0.75 | 4.0 ± NA | 2.0 ± 2.65 | 3.4 ± 2.27 |
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Studies of the drug tested here: Rilonacept
Kiniksa Pharmaceuticals (UK), Ltd.