A Pilot Study of KPL-914 in Recurrent Pericarditis

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

January 24, 2018

Primary Completion Date

May 17, 2019

Study Completion Date

May 17, 2019

Conditions
Recurrent Pericarditis
Interventions
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."

Trial Locations (14)

11215

Ellipsis Research Group, Brooklyn

20010

Medstar Washington Hospital Center, Washington D.C.

23298

Virginia Commonwealth University, Richmond

32224

Mayo Clinic Jacksonville, Jacksonville

32720

Avail Clinical Research, LLC, DeLand

42303

Research Integrity, LLC, Owensboro

44195

Cleveland Clinic, Cleveland

46237

Franciscan Physician Network Indiana Heart Physicians Cardiovascular Research Program, Indianapolis

55407

Minneapolis Heart Institute Foundation, Minneapolis

55905

Mayo Clinic, Rochester

60523

Affinity Clinical Research Institute, Oak Brook

77084

BI Research Center, Houston

98122

Swedish Medical Center, Seattle

05401

University of Vermont Medical Center, Burlington

All Listed Sponsors
lead

Kiniksa Pharmaceuticals (UK), Ltd.

INDUSTRY

NCT03980522 - A Pilot Study of KPL-914 in Recurrent Pericarditis | Biotech Hunter | Biotech Hunter