26
Participants
Start Date
January 24, 2018
Primary Completion Date
May 17, 2019
Study Completion Date
May 17, 2019
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."
Ellipsis Research Group, Brooklyn
Medstar Washington Hospital Center, Washington D.C.
Virginia Commonwealth University, Richmond
Mayo Clinic Jacksonville, Jacksonville
Avail Clinical Research, LLC, DeLand
Research Integrity, LLC, Owensboro
Cleveland Clinic, Cleveland
Franciscan Physician Network Indiana Heart Physicians Cardiovascular Research Program, Indianapolis
Minneapolis Heart Institute Foundation, Minneapolis
Mayo Clinic, Rochester
Affinity Clinical Research Institute, Oak Brook
BI Research Center, Houston
Swedish Medical Center, Seattle
University of Vermont Medical Center, Burlington
Lead Sponsor
Kiniksa Pharmaceuticals (UK), Ltd.
INDUSTRY