Transition to KPL-387 Monotherapy Dosing & Administration Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKiniksa Pharmaceuticals International, plc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
KPL-387
Drugadministered by subcutaneous injection
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Posology KPL-387Experimental treatment 1 intervention
Group B: Long-Term ExtensionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Posology: Proportion of participants free from Pericarditis Recurrence by Week 16
Time frame
From baseline up to Week 162
Long-Term Extension: Annualized rate of Pericarditis Recurrence through the end of the LTE.
Time frame
Up to 24 MonthsSecondary outcomes
1
Posology: Time to Pericarditis Recurrence by Week 16
Time frame
From baseline up to Week 162
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.
Time frame
Up to 24 Months3
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.
Time frame
Up to 24 Months4
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.
Time frame
Up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kiniksa Pharmaceuticals International, plc
Lead sponsor
Kiniksa Pharmaceuticals, GmbH
Collaborator
Source ClinicalTrials.gov