Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

PHASE2CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

February 4, 2015

Primary Completion Date

November 21, 2016

Study Completion Date

July 23, 2018

Conditions
Homozygous Familial Hypercholesterolemia
Interventions
DRUG

REGN1500 250 mg SC/15 mg/kg IV/450 mg SC

Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.

Trial Locations (5)

Unknown

Los Angeles

Philadelphia

Dallas

Chicoutimi

Amsterdam

All Listed Sponsors
lead

Regeneron Pharmaceuticals

INDUSTRY

NCT02265952 - Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH) | Biotech Hunter | Biotech Hunter