CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
KPL-914drug
Likely dose
KPL-914 320 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03980522
NCT03980522Phase 2Completed
CompareCT.gov

An Open-Label Pilot Study of KPL-914 in Recurrent Pericarditis

Kiniksa Pharmaceuticals (UK), Ltd.·interventional·Posted Jun 10, 2019·Updated May 27, 2021

In Brief

A Phase 2 clinical trial evaluating KPL-914 for Recurrent Pericarditis. Completed, enrolled 26 participants across 14 sites.

Detailed Summary

The purpose of this study is to assess the preliminary efficacy and safety of KPL-914 treatment in participants with recurrent pericarditis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Pericarditis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 10, 2019
Enrollment StartJan 24, 2018
Primary CompletionMay 17, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.1 years ago

Interventions

KPL-914drug

KPL-914 (rilonacept) will be provided in its commercially available formulation as a lyophilized powder to be reconstituted for SC administration. Adult participants (≥ 18 years of age) KPL-914 will be administered as an initial loading dose of 320 mg SC, delivered as 2 subcutaneous injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks. Pediatric participants (6 to \<18 years of age) KPL-914 will be administered with an initial loading dose of 4.4 mg/kg, up to a maximum of 320 mg, delivered as 2 subcutaneous injections of 2.2 mg/kg each with a maximum single-injection volume of 2 mL. Participants considered to be 'treatment responders' will be offered participation in an optional 18-week extension period (EP) in which KPL-914 can be continued for a total duration of KPL-914 treatment of up to 24 weeks.