A Phase 2/3 interventional study of KPL-387 and Placebo in Pericarditis, Pericarditis Acute and Recurrent Pericarditis, sponsored by Kiniksa Pharmaceuticals International, plc. Recruiting at 67 sites in 10 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Kiniksa Pharmaceuticals International, plc · Phase 2/3, Interventional, and Treatment
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
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.
54 studies on the registry are indexed under Pericarditis; 23 are open to participants now.
This study's planned enrollment of 325 is above the median of 60 across 29 interventional studies indexed under Pericarditis.
Browse Pericarditis studies →Kiniksa Pharmaceuticals International, plc is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In Phase 2 Treatment Period KPL-387 will be administered by subcutaneous (SC) injection every 2 weeks (q2wk) through Week 22.
Drug: KPL-387
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.
Drug: KPL-387 · Drug: Placebo
In Phase 2 Treatment Period KPL-387 will be administered by SC injection q2wk through Week 22.
Drug: KPL-387
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.
Drug: KPL-387 · Drug: Placebo
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.
Drug: KPL-387
RW Period: eligible participants are randomized (1:1 KPL-387 or placebo) to receive double-blinded placebo.
Drug: Placebo
Participants from Phase 2 and Phase 3 who continue into the Long-Term Extension will receive KPL-387.
Drug: KPL-387
administered by subcutaneous injection
administered by subcutaneous injection
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
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
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Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Kiniksa Pharmaceuticals International, plc