CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
REGN1500 250 mg SC/15 mg/kg IV/450 mg SCdrug
Likely dose
REGN1500 250 mg SC/15 mg/kg IV/450 mg SCfrom 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/NCT02265952
NCT02265952Phase 2Completed
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An Open-Label, Single-Arm, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Single and Multiple Doses of REGN1500 in Patients With Homozygous Familial Hypercholesterolemia

Regeneron Pharmaceuticals·interventional·Posted Oct 16, 2014·Updated Dec 9, 2019

In Brief

A Phase 2 clinical trial evaluating REGN1500 250 mg SC/15 mg/kg IV/450 mg SC for Homozygous Familial Hypercholesterolemia. Completed, enrolled 9 participants across 5 sites in 3 countries.

Detailed Summary

This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHomozygous Familial Hypercholesterolemia
CountriesCanada, Netherlands, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 16, 2014
Enrollment StartFeb 4, 2015
Primary CompletionNov 21, 2016
Study CompletionJul 23, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.7 years ago

Interventions

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

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.