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New treatment option for Pericarditis
Official title Phase 2/3 Study of KPL-387 in Recurrent Pericarditis
ClinicalTrials.gov ID: NCT07010159
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 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
- This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
- Phase 3: a large, late-stage study
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
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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
- 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.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Ventura, California, United States
- Westminster, Colorado, United States
- Columbus, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Overland Park, Kansas, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Austin, Texas, United States
+ 28 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Gilbert, Arizona, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; Santa Monica, California, United States; Ventura, California, United States and 42 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.