NCT03980522

A Pilot Study of KPL-914 in Recurrent Pericarditis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Kiniksa Pharmaceuticals (UK), Ltd. · Industry
• Sex: All
• Age: 6 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is an open-label, single-arm pilot study to explore clinical and biochemical endpoints of pericarditis symptomatology and to collect data to assess inter- and intra-subject variability on both at-baseline and on-treatment parameters. This study consists of 5 distinct Parts, and all participants will be treated with once-weekly subcutaneously (SC)-administered injections of KPL-914.There is an optional 18-week extension period.

Conditions

• Recurrent Pericarditis

Interventions

Type	Name	Description
DRUG	KPL-914	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.

Timeline

• Start date: 2018-01-24
• Primary completion: 2019-05-17
• Completion: 2019-05-17
• First posted: 2019-06-10
• Last updated: 2021-05-27
• Results posted: 2021-05-27

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study