Recurrent PericarditisPhase 2NCT03980522

A Pilot Study of KPL-914 in Recurrent Pericarditis

A Phase 2 study testing KPL-914 in people with Recurrent Pericarditis, run by Kiniksa Pharmaceuticals (UK), Ltd. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the preliminary efficacy and safety of KPL-914 treatment in participants with recurrent pericarditis. Read more about this study

Who is it for?: Ages 6 to 75 years
Conditions the study is for: Recurrent Pericarditis
What is being tested?: KPL-914
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 14 sitesUnited States
Study dates: 24 Jan 2018to 17 May 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Has given consent (or assent, if applicable) and signed an Informed Consent Form (ICF) (or informed assent form, if applicable).
Male or female, of any ethnic origin.
6 to 75 years of age, inclusive.
If used, has received non-steroidal anti-inflammatory drugs (NSAIDs), and/or colchicine and/or corticosteroids (in any combination) at stable dose levels for at least 7 days prior to study drug dosing (although stable doses for a shorter period will be acceptable if in the opinion of the Investigator, in consultation with the Sponsor, a shorter period of stability is not anticipated to alter the baseline CRP values) and is anticipated to continue these concomitant medications at these dose levels for the duration of the active Treatment Period.
If female of child-bearing potential, must be nonpregnant and nonlactating and must agree to use an effective method of contraception, e.g., hormonal contraception or double-barrier birth control.
Is able to adequately maintain a medication diary.

Show all 11Show fewer

Agrees to refrain from making any new, major life-style changes that may affect pericarditis symptoms (e.g., starting a new diet or changing exercise pattern) from the time of signature of the ICF (or informed assent form, if applicable) to the End-of-Trial Visit.
Parts 1, 2 and 4:
Subjects eligible for Parts 1, 2 and 4 have to present during a symptomatic episode of recurrent idiopathic pericarditis (RIP; Parts 1 and 2) and post pericardiotomy syndrome (PPS; Part 4) and a history of at least one pericarditis recurrence. They can be enrolled into Part 1 or 4 if the CRP value at screening is >1 mg/dL, and into Part 2 if a CRP ≤1 mg/dL (attributed to concomitant medications e.g., corticosteroids), and there is an evidence of pericardial inflammation on cardiac MRI confirmed by the imaging core lab.
Enrollment into Part 3 and 5:
Subjects eligible for Part 3 of this study have to present with corticosteroid-dependent RIP or PPS and history of at least 2 pericarditis recurrences.

Who cannot join

Has a diagnosis of pericarditis that was secondary to specific excluded etiologies, including tuberculous, neoplastic, or purulent etiologies, post-myocardial infarction (early or late), thoracic trauma, myocarditis, or systemic diseases including autoinflammatory diseases, autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.).
Has a history of immunodepression, including a positive human immunodeficiency virus test result.
Has received treatment within the 6-month period before dosing with any systemic immunosuppressants (other than, for example, corticosteroids or mycophenolate) which, in the opinion of the Investigator (in consultation with the Sponsor), may interfere with the study endpoints.
Currently receiving other interleukin (IL)-1 or IL-6 blockers, Janus-activating kinase (JAK) or tumor necrosis factor (TNF) inhibitors.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Ellipsis Research Group
Brooklyn, New York, 11215
University of Vermont Medical Center
Burlington, Vermont, 05401
Cleveland Clinic
Cleveland, Ohio, 44195
Avail Clinical Research, LLC
DeLand, Florida, 32720
BI Research Center
Houston, Texas, 77084
Franciscan Physician Network Indiana Heart Physicians Cardiovascular Research Program
Indianapolis, Indiana, 46237
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Affinity Clinical Research Institute
Oak Brook, Illinois, 60523
Research Integrity, LLC
Owensboro, Kentucky, 42303
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
Swedish Medical Center
Seattle, Washington, 98122
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: An Open-Label Pilot Study of KPL-914 in Recurrent Pericarditis

The purpose of this study is to assess the preliminary efficacy and safety of KPL-914 treatment in participants with recurrent pericarditis.

Read the detailed description

This is an open-label, single-arm pilot study to explore clinical and biochemical endpoints of pericarditis symptomatology and to collect data to assess inter- and intra-subject variability on both at-baseline and on-treatment parameters. This study consists of 5 distinct Parts, and all participants will be treated with once-weekly subcutaneously (SC)-administered injections of KPL-914.There is an optional 18-week extension period.

Conditions: Recurrent Pericarditis
Being tested: KPL-914
Medical subject headings: Pericarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KPL-914Drug
Also called rilonacept
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.

Study groups in NCT03980522
Study group	Role	What they receive
KPL-914: Part 1 Participants	Experimental	Part 1 enrolls symptomatic participants with recurrent idiopathic pericarditis (RIP) with an elevated marker of systemic inflammation (C-reactive protein [CRP] > 1mg/dL). Receives: Drug: KPL-914
KPL-914: Part 2 Participants	Experimental	Part 2 enrolls symptomatic participants with RIP with CRP ≤1 mg/dL which, in the opinion of the Investigator, can be attributed to concomitant medications (e.g., corticosteroids) and with pericardial inflammation present on cardiac magnetic resonance imaging (MRI) confirmed by the imaging core lab. Receives: Drug: KPL-914
KPL-914: Part 3 Participants	Experimental	Part 3 enrolls participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis. Receives: Drug: KPL-914
KPL-914: Part 4 Participants	Experimental	Part 4 enrolls symptomatic participants with recurrent post pericardiotomy syndrome (PPS) with an elevated marker of systemic inflammation (CRP > 1mg/dL). Receives: Drug: KPL-914
KPL-914: Part 5 Participants	Experimental	Part 5 enrolls participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis. Receives: Drug: KPL-914

What is being measured

The primary outcome is the main question the study is designed to answer.

Parts 1, 2 and 4: Pretreatment C-Reactive Protein (CRP) Levels
Measured: 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
Measured: 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").
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 201817 May 2019

First posted10 Jun 2019
Study start24 Jan 2018
Primary completion17 May 2019
Study completion17 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Recurrent PericarditisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03980522
Sponsor's protocol ID: KPL-914-C001
Status last verified: May 2021
First submitted: 5 Jun 2019
Last updated: 27 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Klein AL, Lin D, Cremer PC, Nasir S, Luis SA, Abbate A, Ertel A, LeWinter M, Beutler A, Fang F, Paolini JF. Efficacy and safety of rilonacept for recurrent pericarditis: results from a phase II clinical trial. Heart. 2020 Nov 23;107(6):488-96. doi: 10.1136/heartjnl-2020-317928. Online ahead of print.
PubMed 33229362
Lin D, Klein A, Cella D, Beutler A, Fang F, Magestro M, Cremer P, LeWinter MM, Luis SA, Abbate A, Ertel A, Litcher-Kelly L, Klooster B, Paolini JF. Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept. BMC Cardiovasc Disord. 2021 Apr 21;21(1):201. doi: 10.1186/s12872-021-02008-3.
PubMed 33882846

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Pilot Study of KPL-914 in Recurrent Pericarditis
ClinicalTrials.gov ID: NCT03980522
Acronym / sponsor ID: KPL-914-C001
Conditions: Recurrent Pericarditis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Kiniksa Pharmaceuticals (UK), Ltd.Industry (pharma, biotech, devices)
Study start: 24 Jan 2018 (actual)
Primary completion: 17 May 2019 (actual)
Study completion: 17 May 2019 (actual)
First posted: 10 Jun 2019 (actual)
Results: Posted 27 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the preliminary efficacy and safety of KPL-914 treatment in participants with recurrent pericarditis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
KPL-914: Part 1 Participants	Experimental	Drug: KPL-914Part 1 enrolls symptomatic participants with recurrent idiopathic pericarditis (RIP) with an elevated marker of systemic inflammation (C-reactive protein [CRP] > 1mg/dL).
KPL-914: Part 2 Participants	Experimental	Drug: KPL-914Part 2 enrolls symptomatic participants with RIP with CRP ≤1 mg/dL which, in the opinion of the Investigator, can be attributed to concomitant medications (e.g., corticosteroids) and with pericardial inflammation present on cardiac magnetic resonance imaging (MRI) confirmed by the imaging core lab.
KPL-914: Part 3 Participants	Experimental	Drug: KPL-914Part 3 enrolls participants with corticosteroid-dependent RIP not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis.
KPL-914: Part 4 Participants	Experimental	Drug: KPL-914Part 4 enrolls symptomatic participants with recurrent post pericardiotomy syndrome (PPS) with an elevated marker of systemic inflammation (CRP > 1mg/dL).
KPL-914: Part 5 Participants	Experimental	Drug: KPL-914Part 5 enrolls participants with corticosteroid-dependent recurrent PPS not experiencing symptoms which would meet the diagnostic criteria for a flare of pericarditis.

Who may qualify

Ages: 6 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Has given consent (or assent, if applicable) and signed an Informed Consent Form (ICF) (or informed assent form, if applicable).
Male or female, of any ethnic origin.
6 to 75 years of age, inclusive.
If used, has received non-steroidal anti-inflammatory drugs (NSAIDs), and/or colchicine and/or corticosteroids (in any combination) at stable dose levels for at least 7 days prior to study drug dosing (although stable doses for a shorter period will be acceptable if in the opinion of the Investigator, in consultation with the Sponsor, a shorter period of stability is not anticipated to alter the baseline CRP values) and is anticipated to continue these concomitant medications at these dose levels for the duration of the active Treatment Period.
If female of child-bearing potential, must be nonpregnant and nonlactating and must agree to use an effective method of contraception, e.g., hormonal contraception or double-barrier birth control.

Key exclusion criteria (4 listed)

Has a diagnosis of pericarditis that was secondary to specific excluded etiologies, including tuberculous, neoplastic, or purulent etiologies, post-myocardial infarction (early or late), thoracic trauma, myocarditis, or systemic diseases including autoinflammatory diseases, autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.).
Has a history of immunodepression, including a positive human immunodeficiency virus test result.
Has received treatment within the 6-month period before dosing with any systemic immunosuppressants (other than, for example, corticosteroids or mycophenolate) which, in the opinion of the Investigator (in consultation with the Sponsor), may interfere with the study endpoints.
Currently receiving other interleukin (IL)-1 or IL-6 blockers, Janus-activating kinase (JAK) or tumor necrosis factor (TNF) inhibitors.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KPL-914Also: rilonaceptKPL-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.	Drug	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

Primary outcome

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
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)
The average level of pericarditis pain over previous 24 hours was assessed by participants at each visit using 11-point pain NRS (where "0" indicates "no pain" and "10" indicates pain "as bad as it could be").
Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores
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)
The average level of pericarditis pain over previous 24 hours was assessed by participants at each visit using 11-point pain NRS (where "0" indicates "no pain" and "10" indicates pain "as bad as it could be").
Parts 3 and 5: Change From Baseline Over Time in CRP Levels
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)
Baseline is defined as the last non-missing assessment prior to the first study drug administration.
Parts 3 and 5: Change From Baseline Over Time in Pain NRS Scores
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)
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.

Results and safety

Results posted to the registry on 27 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
KPL-914: Part 1 Participants	13	12
KPL-914: Part 2 Participants	3	3
KPL-914: Part 3 Participants	6	6
KPL-914: Part 4 Participants	1	1
KPL-914: Part 5 Participants	3	3

Primary outcome: 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). Mean (Standard Deviation). Unit: mg/dL

Measure	KPL-914: Part 1 Participants n = 12	KPL-914: Part 2 Participants n = 3	KPL-914: Part 4 Participants n = 1
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)

KPL-914: Part 1 Participants: Inter-subject variance: 19.1908
KPL-914: Part 2 Participants: Inter-subject variance: 0.0018
KPL-914: Part 4 Participants: Inter-subject variance: 0.0000

Population analysed: 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.

Primary outcome: 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). Mean (Standard Deviation). Unit: mg/dL

Measure	KPL-914: Part 1 Participants n = 12	KPL-914: Part 2 Participants n = 3	KPL-914: Part 4 Participants n = 1
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)

KPL-914: Part 1 Participants: Inter-subject variance: 34.1446
KPL-914: Part 2 Participants: Inter-subject variance: 0.1326
KPL-914: Part 4 Participants: Inter-subject variance: 0.0000

Population analysed: 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.

Primary outcome: Parts 1, 2 and 4: Pretreatment Pain NRS Scores

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). Mean (Standard Deviation). Unit: score on a scale

Measure	KPL-914: Part 1 Participants n = 12	KPL-914: Part 2 Participants n = 3	KPL-914: Part 4 Participants n = 1
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)

KPL-914: Part 1 Participants: Inter-subject variance: 2.8139
KPL-914: Part 2 Participants: Inter-subject variance: 6.9999
KPL-914: Part 4 Participants: Inter-subject variance: 0.0000

Population analysed: 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.

Primary outcome: Parts 1, 2 and 4: On-Treatment Change From Baseline Over Time in Pain NRS Scores

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). Mean (Standard Deviation). Unit: score on a scale

Measure	KPL-914: Part 1 Participants n = 12	KPL-914: Part 2 Participants n = 3	KPL-914: Part 4 Participants n = 1
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)

KPL-914: Part 1 Participants: Inter-subject variance: 1.9968
KPL-914: Part 2 Participants: Inter-subject variance: 0.9047
KPL-914: Part 4 Participants: Inter-subject variance: 0.0000

Population analysed: 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.

Adverse events

Time frame: From first dose of study drug up to 25 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
KPL-914: Part 1 Participants	2 of 12 (16.7%)	12 of 12 (100%)	0 of 12
KPL-914: Part 2 Participants	0 of 3 (0%)	3 of 3 (100%)	0 of 3
KPL-914: Part 3 Participants	0 of 6 (0%)	6 of 6 (100%)	0 of 6
KPL-914: Part 4 Participants	0 of 1 (0%)	1 of 1 (100%)	0 of 1
KPL-914: Part 5 Participants	0 of 3 (0%)	3 of 3 (100%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33229362Klein AL, Lin D, Cremer PC, Nasir S, Luis SA, Abbate A, Ertel A, LeWinter M, Beutler A, Fang F, Paolini JF. Efficacy and safety of rilonacept for recurrent pericarditis: results from a phase II clinical trial. Heart. 2020 Nov 23;107(6):488-96. doi: 10.1136/heartjnl-2020-317928. Online ahead of print.
Derived from this study: PubMed 33882846Lin D, Klein A, Cella D, Beutler A, Fang F, Magestro M, Cremer P, LeWinter MM, Luis SA, Abbate A, Ertel A, Litcher-Kelly L, Klooster B, Paolini JF. Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept. BMC Cardiovasc Disord. 2021 Apr 21;21(1):201. doi: 10.1186/s12872-021-02008-3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Operations Study Director study director

Kiniksa Pharmaceuticals (UK), Ltd.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KPL-914 in people with Recurrent Pericarditis, run by Kiniksa Pharmaceuticals (UK), Ltd. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03980522, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.