BridgeMD
New treatment option for Recurrent Pericarditis
Official title Transition to KPL-387 Monotherapy Dosing & Administration Study
ClinicalTrials.gov ID: NCT07288216
What this study is testing
What is KPL-387?
KPL-387 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for recurrent pericarditis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 16 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Has a documented history of CRP elevation (\> 1 mg/dL) associated with at least one prior acute pericarditis episode, whether the incident event or...
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Santa Monica, California, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Norfolk, Virginia, United States
- Richmond, Virginia, United States
- Ottawa, Ontario, Canada
- Paris, France
- Poitiers, France
- Toulouse, France
- Athens, Greece
- Nea Ionia, Greece
+ 12 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Santa Monica, California, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.