Testing KPL-387 against a placebo for pericarditis
Official title: Phase 2/3 Study of Participants With Recurrent Pericarditis Evaluating the Efficacy and Safety of KPL-387
A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants With Recurrent Pericarditis
- Phase 2
- 7 groups
- One site, in Ottawa
- Recruiting
Interventions
- Medication
KPL-387
administered by subcutaneous injection
- Medication
Placebo
administered by subcutaneous injection
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Investigational Site 027
Ottawa, Ontario
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → 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 3Phase 3A large study comparing a treatment against the current standard.Read more →: Taking NSAIDs and/or colchicine and/or glucocorticoids (in any combination)
Exclusion
- −Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → and 3: Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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 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.
- −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, has any other medical condition that could adversely affect the subject's participation or interfere with study evaluations.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 7 groups in this study.
Groups A, C, E and G receive KPL-387.
Registry label: A: Phase 2 KPL-387 100mg SC q2wk · C: Phase 2 KPL-387 300mg SC q2wk · E: Phase 3 KPL-387 SC · G: Long-Term Extension
Groups B and D receive KPL-387, together with one or more of: PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
Registry label: B: Phase 2 KPL-387 100mg SC q4wk · D: Phase 2 KPL-387 300mg SC q4wk
Group F, the placebo group, receives Placebo.
Registry label: F: Phase 3 Placebo SC
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 80 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 325 people.
The study is currently expected to finish around December 2029.
The main measurement is taken over: From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to Week 24.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →: Time to Treatment Response by Week 24 — measured over From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to Week 24.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more →: Time to Pericarditis Recurrence — measured over From Baseline in the RW Period.
Long-Term Extension: Annualized rate of Pericarditis Recurrence — measured over Up to 24 Months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07010159 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About KPL-387Drug
administered by subcutaneous injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
administered by subcutaneous injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 80 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 80 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From BaselineBaselineYour starting measurements, taken before treatment begins.Read more → up to Week 24.
The study as a whole is currently expected to finish around 2029-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 325 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Ottawa, Ontario, Canada; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States; New York, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Other Sites (4)
Investigational Site 055
Minneapolis, Minnesota, United States
Investigational Site 012
Rochester, Minnesota, United States
Investigational Site 015
New York, New York, United States
Investigational Site 022
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.