Recurrent PericarditisPhase 2NCT07288216
Transition to KPL-387 Monotherapy Dosing & Administration Study
A Phase 2 study testing KPL-387 in people with Recurrent Pericarditis and Heart Diseases, run by Kiniksa Pharmaceuticals International, plc at 47 sites in 10 countries.
Trial summary
The primary objective of this study is to characterize the efficacy and safety of dosing regimens used to transition from prior pericarditis therapies to KPL-387 monotherapy in participants with well-controlled recurrent pericarditis on standard therapies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recurrent Pericarditis, Heart Diseases, Pericarditis
- What is being tested?
- KPL-387
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 47 sitesin 10 countries
- Study dates
- 25 Mar 2026to 31 Dec 2029
- Phase
- Phase 2
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
- Has well-controlled recurrent pericarditis (i.e., including having CRP < 0.5 mg/dL within 14 days of Baseline and a pericarditis pain NRS score ≤ 3 at Baseline)
- Has a documented history of CRP elevation (> 1 mg/dL) associated with at least one prior acute pericarditis episode, whether the incident event or any pericarditis recurrence
- Has received treatment for RP for at least 3 months prior to Baseline with standard therapy(ies) and is currently on a stable dosing regimen including NSAIDs and/or colchicine, and/or glucocorticoids or an IL-1 pathway inhibitor (anakinra or rilonacept).
Who cannot join
- Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies
- Has had a pericarditis recurrence in the last 3 months prior to Baseline
- Has received an investigational drug during the 4 weeks before study drug administration or is planning to receive an investigational drug at any time during the study.
- Has a history of active or untreated, latent tuberculosis (TB) prior to screening.
- Has a history of immunodeficiency.
- Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
Show all 12Show fewer
- 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.
- 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).
- 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.
- 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.
- Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).
- 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
47 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
47 sites in 10 countries
United States21 sites, 21 recruiting
- Recruiting
Investigational Site 005
Austin, Texas, 78705
- Recruiting
Investigational Site 025
Baltimore, Maryland, 21287
- Recruiting
Investigational Site 043
Boston, Massachusetts, 02199
- Recruiting
Investigational Site 004
Charlottesville, Virginia, 22903
- Recruiting
Investigational Site 013
Chicago, Illinois, 60611
- Recruiting
Investigational Site 009
Cincinnati, Ohio, 45219
- Recruiting
Investigational Site 040
Cleveland, Ohio, 44195
- Recruiting
Investigational Site 047
Dallas, Texas, 75235
- Recruiting
Investigational Site 006
Houston, Texas, 77030
- Recruiting
Investigational Site 039
Jacksonville, Florida, 32224
- Recruiting
Investigational Site 045
La Jolla, California, 92037
- Recruiting
Investigational Site 014
Los Angeles, California, 90048
- Recruiting
Investigational Site 011
New York, New York, 10016
- Recruiting
Investigational Site 003
New York, New York, 10032
- Recruiting
Investigational Site 001
Norfolk, Virginia, 23507
- Recruiting
Investigational Site 031
Phoenix, Arizona, 85054
- Recruiting
Investigational Site 008
Richmond, Virginia, 23284
- Recruiting
Investigational Site 028
Rochester, Minnesota, 55905
- Recruiting
Investigational Site 002
Santa Monica, California, 90404
- Recruiting
Investigational Site 042
St Louis, Missouri, 63130
- Recruiting
Investigational Site 046
Washington D.C., District of Columbia, 20010
Italy6 sites, 6 recruiting
- Recruiting
Investigational Site 044
Florence, 50134
- Recruiting
Investigational Site 034
Genoa, 16147
- Recruiting
Investigational Site 021
Milan, 20157
- Recruiting
Investigational Site 036
Padua, 35143
- Recruiting
Investigational Site 033
Udine, 33100
- Recruiting
Investigational Site 037
Varese, 21100
Spain5 sites, 5 recruiting
- Recruiting
Investigational Site 019
Barcelona, 08017
- Recruiting
Investigational Site 015
Barcelona, 08035
- Recruiting
Investigational Site 017
Madrid, 28034
- Recruiting
Investigational Site 016
Madrid, 28850
- Recruiting
Investigational Site 018
Valencia, 46015
France4 sites, 4 recruiting
- Recruiting
Investigational Site 027
Paris, 75013
- Recruiting
Investigational Site 026
Poitiers, 86000
- Recruiting
Investigational Site 032
Toulouse, 31400
- Recruiting
Investigational Site 038
Toulouse, 31400
Greece3 sites, 3 recruiting
- Recruiting
Investigational Site 035
Athens, 115 28
- Recruiting
Investigational Site 023
Nea Ionia, 142 33
- Recruiting
Investigational Site 024
Voula, 166 73
United Kingdom3 sites, 3 recruiting
- Recruiting
Investigational Site 012
London, EC1A 7BE
- Recruiting
Investigational Site 022
London, NW3 2QG
- Recruiting
Investigational Site 007
London, SE1 7EH
Serbia2 sites, 2 recruiting
- Recruiting
Investigational Site 030
Belgrade, 1100
- Recruiting
Investigational Site 029
Belgrade, 11040
Canada1 site, 1 recruiting
- Recruiting
Investigational Site 010
Ottawa, Ontario, K1N 6N5
About this study
Official title: A Phase 2 Posology Study With Long-Term Extension in Participants With Well-Controlled Recurrent Pericarditis to Evaluate the Efficacy and Safety of Transition Regimens to KPL-387 Monotherapy From Standard Therapies
The primary objective of this study is to characterize the efficacy and safety of dosing regimens used to transition from prior pericarditis therapies to KPL-387 monotherapy in participants with well-controlled recurrent pericarditis on standard therapies.
Read the detailed description
During the Posology (Dosing and Administration) Study, participants on oral pericarditis therapies alone (i.e., non-steroidal anti-inflammatory drugs [NSAIDs], colchicine, and/or glucocorticoids) and participants on Interleukin-1 (IL-1) pathway inhibition drugs will transition to KPL-387 per protocol guidelines. Participants will receive KPL-387 for up to 16 weeks in the Posology Study.
At study visits throughout the Posology Study, participants will be queried for symptoms of chest pain (and participants will fill out pericarditis pain numerical rating scale [NRS] scores) and will be assessed for physical signs (e.g., pericardial friction rub) and laboratory evidence of pericarditis activity (e.g., C-reactive protein [CRP]) as well as treatment tolerability and pharmacokinetics (PK). Participants experiencing new or worsening symptoms consistent with pericarditis will be managed per study protocol.
All active, enrolled participants in the Posology Study who have not completed an End of Treatment (EOT) Visit may be eligible to transition into the Long-Term Extension (LTE) following completion of the Week 16 Visit. The Week 16 Visit will serve as both a Posology Study End of Study Visit and a Baseline Visit for the LTE. Participants who choose not to participate in the LTE will complete an EOT Visit followed by a Safety Follow-Up until 8 weeks after the last KPL-387 dose administration.
The open-label LTE is designed to evaluate the long-term efficacy and safety of KPL-387 in recurrent pericarditis (RP). Treatment in the LTE may continue until the participant has received up to 24 months of treatment in the LTE or until KPL-387 is approved for commercial use in that region to treat pericarditis, whichever occurs first.
At study visits throughout the LTE, participants will be queried for symptoms of chest pain (and participants will fill out pericarditis pain NRS scores) and will be assessed for physical signs (e.g., pericardial friction rub) and laboratory evidence of pericarditis activity (e.g., CRP) as well as treatment tolerability and PK. Participants experiencing new or worsening symptoms consistent with pericarditis will be managed as described in the protocol.
- Conditions
- Recurrent Pericarditis, Heart Diseases, Pericarditis
- Being tested
- KPL-387
- Keywords
- Recurrence, Recurrent, KPL-387, Recurrent Pericarditis
- Medical subject headings
- Pericarditis, Heart Diseases, 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
| Study group | Role | What they receive |
|---|---|---|
| Posology KPL-387 | Experimental | In Posology Study, KPL-387 will be administered by subcutaneous (SC) injection through Week 16. Receives: Drug: KPL-387 |
| Long-Term Extension | Experimental | Participants from Posology Study who continue into the Long-Term Extension will receive KPL-387 for up to 24 months or until KPL-387 is approved for commercial use in that region to treat pericarditis, whichever occurs first. Receives: Drug: KPL-387 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posology: Proportion of participants free from Pericarditis Recurrence by Week 16
Measured: From baseline up to Week 16
Long-Term Extension: Annualized rate of Pericarditis Recurrence through the end of the LTE.
Measured: Up to 24 Months
Secondary outcomes (5)
Posology: Time to Pericarditis Recurrence by Week 16
Measured: From baseline up to Week 16
Long Term Extension: Change from LTE Baseline in SF-36v2 Physical Component Summary score through the end of the LTE
SF-36 (36-item Short Form Survey) Physical Component determines participants' quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; Scores on each item are summed and averaged (range: 0=worst to 100=best) with higher scores indicating better health. Increases from baseline indicate improvement.
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
SF-36 (36-item Short Form Survey) Mental Component determines participants' quality of life by assessing 1) vitality; 2) limitations in social functioning because of physical or emotional problems; 3) limitations in usual role due to emotional problems; and 4) general mental health. Scores on each item are summed and averaged (range: 0=worst to 100=best) with higher scores indicating better health. Increases from baseline indicate improvement.
Measured: Up to 24 Months
Long Term Extension: Change from LTE Baseline in EQ-5D-5L individual index scores over time through the end of the LTE
The EQ-5D-5L (EuroQol-5 Dimension 5-level) is a self-reported health status questionnaire that consists of 6 questions used to calculate a health utility score for use in health economic analysis. There are 2 components to the EQ-5D-5L: a 5-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. Individual and index scores range from 0 to 1, with low scores representing a higher level of dysfunction.
Measured: Up to 24 months
Long Term Extension: Change from LTE Baseline in EQ-5D-5L visual analog scale (VAS) over time through the end of the LTE.
The EQ-5D-5L (EuroQol-5 Dimension 5-level) is a self-reported health status questionnaire that consists of 6 questions used to calculate a health utility score for use in health economic analysis. There are 2 components to the EQ-5D-5L: a 5-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
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 posted17 Dec 2025
- Study start25 Mar 2026
- 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 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
- Single group
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT07288216
- Sponsor's protocol ID
- KPL-387-C212
- Other IDs
- 2025-523234-66, 2025
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No