PericarditisPhase 2/3PASTORALENCT07010159
Phase 2/3 Study of Participants With Recurrent Pericarditis Evaluating the Efficacy and Safety of KPL-387
A Phase 2/3 study testing KPL-387 in people with Pericarditis and Pericarditis Acute, run by Kiniksa Pharmaceuticals International, plc at 66 sites in 10 countries.
Trial summary
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pericarditis, Pericarditis Acute, Recurrent Pericarditis
- What is being tested?
- KPL-387
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 325 participants
- Where
- 66 sitesin 10 countries
- Study dates
- 25 Jul 2025to 31 Dec 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 2 and 3: Has a diagnosis of recurrent pericarditis
- Phase 2 and 3: Has signs and symptoms of recurrent pericarditis despite treatment with standard therapies
- Phase 2 and 3: Weighs at least 40 kg
- Phase 2: Taking NSAIDS and/or colchicine (in any combination)
- Phase 3: Taking NSAIDs and/or colchicine and/or glucocorticoids (in any combination)
Who cannot join
- Phase 2 and 3: Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.
- Phase 2 and 3: Has received an investigational drug during the 4 weeks before screening or is planning to receive an investigational drug at any time during the study.
- Phase 2 and 3: Has a history of active or untreated, latent tuberculosis (TB) prior to screening.
- Phase 2 and 3: Has a history of immunodeficiency.
- Phase 2 and 3: Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
- Phase 2 and 3: Has chest x-ray at Screening or within 12 weeks before first study drug administration, with evidence of malignancy, abnormality consistent with prior or active TB infection or active infection.
Show all 11Show fewer
- Phase 2 and 3: Has a history of malignancy of any organ system within the past 5 years before Screening (other than a successfully treated non metastatic cutaneous squamous cell carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix).
- Phase 2 and 3: Has a known or suspected current active infection or a history of chronic or recurrent infectious disease (> 3 episodes in prior 12 months), including but not limited to, genitourinary infection, chest infection, sinusitis, or skin/soft tissue infection.
- Phase 2 and 3: Has had a serious infection, has been admitted to the hospital for an infection, or has been treated for a documented infection requiring antibiotics for a documented infection within 2 weeks prior to first study drug administration.
- Phase 2 and 3: Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).
- Phase 2 and 3: In the Investigator's opinion, has any other medical condition that could adversely affect the subject's participation or interfere with study evaluations.
Trial locations and contacts
66 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
66 sites in 10 countries
United States32 sites, 30 recruiting
- Recruiting
Investigational Site 005
Austin, Texas, 78705
- Recruiting
Investigational Site 043
Baltimore, Maryland, 21287
- Recruiting
Investigational Site 054
Boston, Massachusetts, 02411
- Recruiting
Investigational Site 042
Burlington, Vermont, 05401
- Recruiting
Investigational Site 006
Charlottesville, Virginia, 22903
- Recruiting
Investigational Site 004
Chicago, Illinois, 60611
- Recruiting
Investigational Site 009
Cincinnati, Ohio, 45219
- Recruiting
Investigational Site 003
Cleveland, Ohio, 44195
- Withdrawn
Investigational Site 001
Columbus, Georgia, 31904
- Recruiting
Investigational Site 018
Gilbert, Arizona, 85297
- Recruiting
Investigational Site 066
Houston, Texas, 77004
- Recruiting
Investigational Site 013
Houston, Texas, 77030
- Recruiting
Investigational Site 014
Indianapolis, Indiana, 46184
- Recruiting
Investigational Site 050
Kansas City, Missouri, 64111
- Recruiting
Investigational Site 046
Kansas City, Missouri, 66160
- Recruiting
Investigational Site 064
La Jolla, California, 92037
- Recruiting
Investigational Site 030
Los Angeles, California, 90048
- Recruiting
Investigational Site 055
Minneapolis, Minnesota, 55407
- Recruiting
Investigational Site 015
New York, New York, 10016
- Recruiting
Investigational Site 022
New York, New York, 10032
- Recruiting
Investigational Site 023
Norfolk, Virginia, 23507
- Withdrawn
Investigational Site 002
Overland Park, Kansas, 66221
- Recruiting
Investigational Site 053
Phoenix, Arizona, 85054
- Recruiting
Investigational Site 045
Richmond, Virginia, 23284
- Recruiting
Investigational Site 012
Rochester, Minnesota, 55905
- Recruiting
Investigational Site 008
San Francisco, California, 94158
- Recruiting
Investigational Site 044
Santa Monica, California, 90404
- Recruiting
Investigational Site 065
Seattle, Washington, 98122
- Recruiting
Investigational Site 062
St Louis, Missouri, 63130
- Recruiting
Investigational Site 058
Ventura, California, 93003
- Recruiting
Investigational Site 061
Washington D.C., District of Columbia, 20010
- Recruiting
Investigational Site 016
Westminster, Colorado, 80023
Italy10 sites, 10 recruiting
- Recruiting
Investigational Site 060
Florence, 50134
- Recruiting
Investigational Site 029
Genoa, 16132
- Recruiting
Investigational Site 040
Genoa, 16147
- Recruiting
Investigational Site 056
Milan, 20132
- Recruiting
Investigational Site 063
Milan, 20162
- Recruiting
Investigational Site 007
Milan, 20157
- Recruiting
Investigational Site 050
Padua, 35143
- Recruiting
Investigational Site 059
Turin, 10126
- Recruiting
Investigational Site 033
Udine, 33100
- Recruiting
Investigational Site 041
Varese, 21100
France6 sites, 6 recruiting
- Recruiting
Investigational Site 028
Montpellier, 34090
- Recruiting
Investigational Site 021
Paris, 75013
- Recruiting
Investigational Site 036
Pessac, 33600
- Recruiting
Investigational Site 019
Poitiers, 86000
- Recruiting
Investigational Site 037
Toulouse, 31400
- Recruiting
Investigational Site 038
Toulouse, 31400
Spain5 sites, 5 recruiting
- Recruiting
Investigational Site 048
Barcelona, 08017
- Recruiting
Investigational Site 010
Barcelona, 8035
- Recruiting
Investigational Site 024
Madrid, 28850
- Recruiting
Investigational Site 011
Murcia, 30120
- Recruiting
Investigational Site 057
Valencia, 46015
United Kingdom4 sites, 4 recruiting
- Recruiting
Investigational Site 020
London, EC1A 7BE
- Recruiting
Investigational Site 047
London, NW3 2QG
- Recruiting
Investigational Site 035
London, SE1 7EH
- Recruiting
Investigational Site 017
Southampton, SO17 1BJ
Greece3 sites, 3 recruiting
- Recruiting
Investigational Site 034
Athens, 115 28
- Recruiting
Investigational Site 039
Nea Ionia, 142 33
- Recruiting
Investigational Site 032
Voula, 166 73
Poland2 sites, 2 recruiting
- Recruiting
Investigational Site 051
Warsaw, 02-097
- Recruiting
Investigational Site 031
Warsaw, 02-507
Serbia2 sites, 2 recruiting
- Recruiting
Investigational Site 025
Belgrade, 11000
- Recruiting
Investigational Site 026
Belgrade, 11040
Canada1 site, 1 recruiting
- Recruiting
Investigational Site 027
Ottawa, Ontario, K1N 6N5
About this study
Official title: A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants With Recurrent Pericarditis
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Read the detailed description
This clinical trial is comprised of 3 separate study parts: Phase 2, Phase 3, and Long-Term Extension. The primary objective of Phase 2 is to evaluate how well different dose levels of KPL-387 control the pain and inflammation of pericarditis in a group of participants experiencing an acute episode of recurrent pericarditis. This part of the study will confirm the KPL-387 dose level to be further tested in Phase 3 and the Long-Term Extension. The primary objective of Phase 3 is to confirm the efficacy of KPL-387 for the treatment of recurrent pericarditis and reduction in risk of recurrence in an additional group of participants experiencing an acute episode of recurrent pericarditis. Participants who complete Phase 2 or Phase 3 may be eligible to participate in the Long-Term Extension. The primary objective of the Long-Term Extension is to assess the long-term efficacy of KPL-387 while maintaining long-term disease control. All of the study parts also have other objectives to learn about the safety, tolerability, concentration of KPL-387 in blood, and effects of KPL-387 on blood test markers of immune activity in recurrent pericarditis.
- Conditions
- Pericarditis, Pericarditis Acute, Recurrent Pericarditis
- Being tested
- KPL-387, Placebo
- Keywords
- Recurrence, Recurrent, Recurrent Pericarditis, KPL-387
- Medical subject headings
- Pericarditis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPL-387Drug
administered by subcutaneous injection
PlaceboDrug
administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 KPL-387 100mg SC q2wk | Experimental | In Phase 2 Treatment Period KPL-387 will be administered by subcutaneous (SC) injection every 2 weeks (q2wk) through Week 22. Receives: Drug: KPL-387 |
| Phase 2 KPL-387 100mg SC q4wk | Experimental | In Phase 2 Treatment Period, KPL-387 or placebo (alternating every 2 weeks) will be administered by SC injection q2wk through Week 22 to provide active drug administration every 4 weeks (q4wk) while maintaining treatment concealment. Receives: Drug: KPL-387; Drug: Placebo |
| Phase 2 KPL-387 300mg SC q2wk | Experimental | In Phase 2 Treatment Period KPL-387 will be administered by SC injection q2wk through Week 22. Receives: Drug: KPL-387 |
| Phase 2 KPL-387 300mg SC q4wk | Experimental | In Phase 2 Treatment Period, KPL-387 or placebo (alternating every 2 weeks) will be administered by SC injection q2wk through Week 22 to provide active drug administration q4wk while maintaining treatment concealment. Receives: Drug: KPL-387; Drug: Placebo |
| Phase 3 KPL-387 SC | Experimental | Run-In (RI) Period: participants receive single-blind KPL-387
Randomized Withdrawal (RW) Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded KPL-387. Receives: Drug: KPL-387 |
| Phase 3 Placebo SC | Placebo comparator | RW Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded placebo. Receives: Drug: Placebo |
| Long-Term Extension | Experimental | Participants from Phase 2 and Phase 3 who continue into the Long-Term Extension will receive KPL-387. Receives: Drug: KPL-387 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2: Time to Treatment Response by Week 24
Measured: From Baseline up to Week 24
Phase 3: Time to Pericarditis Recurrence
Measured: From Baseline in the RW Period
Long-Term Extension: Annualized rate of Pericarditis Recurrence
Measured: Up to 24 Months
Secondary outcomes (29)
Phase 2: Time to CRP Normalization (CRP ≤ 0.5 mg/dL) by Week 24
Measured: From Baseline up to Week 24
Phase 2: Time to Pain Response by Week 24
Measured: From Baseline up to Week 24
Phase 2: Percentage of Days With No or Minimal Pain (Numerical Rating Scale (NRS) ≤ 2) While on KPL-387 Treatment Over Time by Week 24
Measured: From Baseline up to Week 24
Phase 2: Proportion of Participants With Normalization of CRP (CRP ≤ 0.5 mg/dL) Over Time by Week 24
Measured: From Baseline up to Week 24
Phase 2: Time to resolution of pericarditis manifestations (i.e. echocardiogram [ECHO] abnormalities, electrocardiogram [ECG] abnormalities, and pericardial rub), when present at Baseline, by Week 16.
Measured: From Baseline up to Week 16
Phase 2: Change from Baseline in SF-36v2® Physical Component Summary score through Week 24.
Measured: From Baseline up to Week 24
Phase 2: Change from Baseline in SF-36v2® Mental Component Summary score through Week 24.
Measured: From Baseline to Week 24
Phase 2: Proportion of participants with Protocol-Defined Pericarditis Recurrence by Week 24.
Measured: From Baseline to Week 24
Phase 2: Change from Baseline in CRP through Week 24.
Measured: From Baseline up to Week 24
Phase 2: Change from Baseline in pericarditis pain NRS score through Week 24.
Measured: From Baseline up to Week 24
Phase 3: Change from RI Baseline in SF-36v2® Mental Component Summary score through the end of the RI Period
Measured: From Baseline up to the end of the RI Period
Phase 3: Time to Treatment Response by the end of the RI Period
Measured: From Baseline up to end of the RI Period
Phase 3: Time to KPL-387 monotherapy by the end of the RI Period
Measured: From Baseline up to end of the RI Period
Phase 3: Time to Pain Response by end of the RI Period
Measured: From Baseline up to end of the RI Period
Phase 3: Time to CRP normalization by the end of the RI Period
Measured: From Baseline up to end of the RI Period
Phase 3: Change from RI Baseline in SF-36v2® Physical Component Summary score through the end of the RI Period.
Measured: From Baseline up to end of the RI Period
Phase 3: Time to resolution of pericarditis manifestations (i.e., ECHO abnormalities, ECG abnormalities, and pericardial rub), when present at RI Baseline, by the end of the RI period.
Measured: From Baseline up to end of the RI Period
Phase 3: Change from RI Baseline in pericarditis pain NRS score through the end of the RI Period.
Measured: From Baseline up to end of the RI Period
Phase 3: Change from RI Baseline in CRP through the end of the RI Period.
Measured: From Baseline up to end of the RI Period
Phase 3: Proportion of participants who maintained Clinical Response at RW Week 16.
Measured: From Baseline up to RW Week 16
Phase 3: Percentage of days with no or minimal pericarditis pain through RW Week 16.
Measured: From Baseline up to RW Week 16
Phase 3: Change from RW Baseline in SF-36v2® Physical Component Summary score at RW Week 16.
Measured: From Baseline up to RW Week 16
Phase 3: Change from RW Baseline in pain NRS score during the RW Period.
Measured: From Baseline through the end of the RW Period
Phase 3: Change from RW Baseline in CRP during the RW Period
Measured: From Baseline through the end of the RW Period
Long-Term Extension: Proportion of participants who maintained Clinical Response through the end of the LTE Period.
Measured: Up to 24 months
Long-Term Extension: Percentage of days with no or minimal pericarditis pain through the end of the LTE Period.
Measured: Up to 24 months
Long-Term Extension: Change from LTE Baseline in SF-36v2® Physical Component Summary score through the end of the LTE Period.
Measured: Up to 24 months
Long-Term Extension: Change from LTE Baseline in SF-36v2® Mental Component Summary score through the end of the LTE Period.
Measured: Up to 24 months
Long-Term Extension: Change from LTE baseline in pain NRS score through the end of the LTE Period.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start25 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiniksa Pharmaceuticals International, plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kiniksa Pharmaceuticals, GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010159
- Sponsor's protocol ID
- KPL-387-C211
- Other IDs
- 2025-521933-10, 2025
- Acronym
- PASTORALE
- Status last verified
- Jul 2026
- First submitted
- 29 May 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants With Recurrent Pericarditis
- ClinicalTrials.gov ID
- NCT07010159
- Acronym / sponsor ID
- PASTORALE / KPL-387-C211
- Conditions
- Pericarditis, Pericarditis Acute, Recurrent Pericarditis
- Keywords
- Recurrence, Recurrent, Recurrent Pericarditis, KPL-387
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Kiniksa Pharmaceuticals International, plcIndustry (pharma, biotech, devices)
- Collaborators
- Kiniksa Pharmaceuticals, GmbH
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Detailed description
This clinical trial is comprised of 3 separate study parts: Phase 2, Phase 3, and Long-Term Extension. The primary objective of Phase 2 is to evaluate how well different dose levels of KPL-387 control the pain and inflammation of pericarditis in a group of participants experiencing an acute episode of recurrent pericarditis. This part of the study will confirm the KPL-387 dose level to be further tested in Phase 3 and the Long-Term Extension. The primary objective of Phase 3 is to confirm the efficacy of KPL-387 for the treatment of recurrent pericarditis and reduction in risk of recurrence in an additional group of participants experiencing an acute episode of recurrent pericarditis. Participants who complete Phase 2 or Phase 3 may be eligible to participate in the Long-Term Extension. The primary objective of the Long-Term Extension is to assess the long-term efficacy of KPL-387 while maintaining long-term disease control. All of the study parts also have other objectives to learn about the safety, tolerability, concentration of KPL-387 in blood, and effects of KPL-387 on blood test markers of immune activity in recurrent pericarditis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Phase 2 KPL-387 100mg SC q2wk | Experimental | Drug: KPL-387In Phase 2 Treatment Period KPL-387 will be administered by subcutaneous (SC) injection every 2 weeks (q2wk) through Week 22. |
| Phase 2 KPL-387 100mg SC q4wk | Experimental | Drug: KPL-387, Drug: PlaceboIn Phase 2 Treatment Period, KPL-387 or placebo (alternating every 2 weeks) will be administered by SC injection q2wk through Week 22 to provide active drug administration every 4 weeks (q4wk) while maintaining treatment concealment. |
| Phase 2 KPL-387 300mg SC q2wk | Experimental | Drug: KPL-387In Phase 2 Treatment Period KPL-387 will be administered by SC injection q2wk through Week 22. |
| Phase 2 KPL-387 300mg SC q4wk | Experimental | Drug: KPL-387, Drug: PlaceboIn Phase 2 Treatment Period, KPL-387 or placebo (alternating every 2 weeks) will be administered by SC injection q2wk through Week 22 to provide active drug administration q4wk while maintaining treatment concealment. |
| Phase 3 KPL-387 SC | Experimental | Drug: KPL-387Run-In (RI) Period: participants receive single-blind KPL-387 Randomized Withdrawal (RW) Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded KPL-387. |
| Phase 3 Placebo SC | Placebo comparator | Drug: PlaceboRW Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded placebo. |
| Long-Term Extension | Experimental | Drug: KPL-387Participants from Phase 2 and Phase 3 who continue into the Long-Term Extension will receive KPL-387. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Phase 2 and 3: Has a diagnosis of recurrent pericarditis
- Phase 2 and 3: Has signs and symptoms of recurrent pericarditis despite treatment with standard therapies
- Phase 2 and 3: Weighs at least 40 kg
- Phase 2: Taking NSAIDS and/or colchicine (in any combination)
- Phase 3: Taking NSAIDs and/or colchicine and/or glucocorticoids (in any combination)
Key exclusion criteria (11 listed)
- Phase 2 and 3: Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.
- Phase 2 and 3: Has received an investigational drug during the 4 weeks before screening or is planning to receive an investigational drug at any time during the study.
- Phase 2 and 3: Has a history of active or untreated, latent tuberculosis (TB) prior to screening.
- Phase 2 and 3: Has a history of immunodeficiency.
- Phase 2 and 3: Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
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-387administered by subcutaneous injection | Drug | Long-Term Extension, Phase 2 KPL-387 100mg SC q2wk, Phase 2 KPL-387 100mg SC q4wk, Phase 2 KPL-387 300mg SC q2wk, Phase 2 KPL-387 300mg SC q4wk, Phase 3 KPL-387 SC |
| Placeboadministered by subcutaneous injection | Drug | Phase 2 KPL-387 100mg SC q4wk, Phase 2 KPL-387 300mg SC q4wk, Phase 3 Placebo SC |
Primary outcome
Phase 2: Time to Treatment Response by Week 24
Time frame: From Baseline up to Week 24
Phase 3: Time to Pericarditis Recurrence
Time frame: From Baseline in the RW Period
Long-Term Extension: Annualized rate of Pericarditis Recurrence
Time frame: Up to 24 Months
29 secondary outcomes
Phase 2: Time to CRP Normalization (CRP ≤ 0.5 mg/dL) by Week 24
Time frame: From Baseline up to Week 24
Phase 2: Time to Pain Response by Week 24
Time frame: From Baseline up to Week 24
Phase 2: Percentage of Days With No or Minimal Pain (Numerical Rating Scale (NRS) ≤ 2) While on KPL-387 Treatment Over Time by Week 24
Time frame: From Baseline up to Week 24
Phase 2: Proportion of Participants With Normalization of CRP (CRP ≤ 0.5 mg/dL) Over Time by Week 24
Time frame: From Baseline up to Week 24
Phase 2: Time to resolution of pericarditis manifestations (i.e. echocardiogram [ECHO] abnormalities, electrocardiogram [ECG] abnormalities, and pericardial rub), when present at Baseline, by Week 16.
Time frame: From Baseline up to Week 16
Phase 2: Change from Baseline in SF-36v2® Physical Component Summary score through Week 24.
Time frame: From Baseline up to Week 24
Phase 2: Change from Baseline in SF-36v2® Mental Component Summary score through Week 24.
Time frame: From Baseline to Week 24
Phase 2: Proportion of participants with Protocol-Defined Pericarditis Recurrence by Week 24.
Time frame: From Baseline to Week 24
Phase 2: Change from Baseline in CRP through Week 24.
Time frame: From Baseline up to Week 24
Phase 2: Change from Baseline in pericarditis pain NRS score through Week 24.
Time frame: From Baseline up to Week 24
Phase 3: Change from RI Baseline in SF-36v2® Mental Component Summary score through the end of the RI Period
Time frame: From Baseline up to the end of the RI Period
Phase 3: Time to Treatment Response by the end of the RI Period
Time frame: From Baseline up to end of the RI Period
Phase 3: Time to KPL-387 monotherapy by the end of the RI Period
Time frame: From Baseline up to end of the RI Period
Phase 3: Time to Pain Response by end of the RI Period
Time frame: From Baseline up to end of the RI Period
Phase 3: Time to CRP normalization by the end of the RI Period
Time frame: From Baseline up to end of the RI Period
Phase 3: Change from RI Baseline in SF-36v2® Physical Component Summary score through the end of the RI Period.
Time frame: From Baseline up to end of the RI Period
Phase 3: Time to resolution of pericarditis manifestations (i.e., ECHO abnormalities, ECG abnormalities, and pericardial rub), when present at RI Baseline, by the end of the RI period.
Time frame: From Baseline up to end of the RI Period
Phase 3: Change from RI Baseline in pericarditis pain NRS score through the end of the RI Period.
Time frame: From Baseline up to end of the RI Period
Phase 3: Change from RI Baseline in CRP through the end of the RI Period.
Time frame: From Baseline up to end of the RI Period
Phase 3: Proportion of participants who maintained Clinical Response at RW Week 16.
Time frame: From Baseline up to RW Week 16
Phase 3: Percentage of days with no or minimal pericarditis pain through RW Week 16.
Time frame: From Baseline up to RW Week 16
Phase 3: Change from RW Baseline in SF-36v2® Physical Component Summary score at RW Week 16.
Time frame: From Baseline up to RW Week 16
Phase 3: Change from RW Baseline in pain NRS score during the RW Period.
Time frame: From Baseline through the end of the RW Period
Phase 3: Change from RW Baseline in CRP during the RW Period
Time frame: From Baseline through the end of the RW Period
Long-Term Extension: Proportion of participants who maintained Clinical Response through the end of the LTE Period.
Time frame: Up to 24 months
Long-Term Extension: Percentage of days with no or minimal pericarditis pain through the end of the LTE Period.
Time frame: Up to 24 months
Long-Term Extension: Change from LTE Baseline in SF-36v2® Physical Component Summary score through the end of the LTE Period.
Time frame: Up to 24 months
Long-Term Extension: Change from LTE Baseline in SF-36v2® Mental Component Summary score through the end of the LTE Period.
Time frame: Up to 24 months
Long-Term Extension: Change from LTE baseline in pain NRS score through the end of the LTE Period.
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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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.
66 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing KPL-387 in people with Pericarditis and Pericarditis Acute, run by Kiniksa Pharmaceuticals International, plc at 66 sites in 10 countries.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Italy, France, Spain, United Kingdom and 5 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Project Manager (781-431-9100, clinicaltrials@kiniksa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2: Time to Treatment Response by Week 24 (time frame: From Baseline up to Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.