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Monoclonal Antibodies

Evinacumab for Hypercholesterolemia

Phase 3
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose at weeks 0, 4, 8, 12; end of infusion at weeks 0.006, 4.006, 8.006, 12.006 and 24
Awards & highlights

Study Summary

This trial will assess the pharmacokinetics, safety, and efficacy of evinacumab in children with homozygous familial hypercholesterolemia.

Eligible Conditions
  • Familial Hypercholesterolemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose at weeks 0, 4, 8, 12; end of infusion at weeks 0.006, 4.006, 8.006, 12.006 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose at weeks 0, 4, 8, 12; end of infusion at weeks 0.006, 4.006, 8.006, 12.006 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) of Evinacumab
Part A: Maximum Observed Serum Concentration (Cmax) of Evinacumab
Part A: Terminal Half-Life (t1/2) of Evinacumab
+1 more
Secondary outcome measures
Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Part B: Absolute Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Week 24
Part B: Area Under the Serum Concentration-time Curve at Steady State (AUCtau.ss) of Evinacumab
+10 more

Side effects data

From 2023 Phase 3 trial • 20 Patients • NCT04233918
33%
Rhinitis allergic
33%
Vitamin D deficiency
33%
Oropharyngeal pain
33%
Cough
17%
Vomiting
17%
Abdominal discomfort
17%
Iron deficiency
17%
Device malfunction
17%
Papilloedema
17%
Headache
17%
Rhinitis
17%
Infusion site extravasation
17%
Constipation
17%
Nasopharyngitis
17%
COVID-19
17%
Apheresis related complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A Evinacumab 15mg
Part B Evinacumab 15mg
Part A-C Evinacumab 15mg
Part B-C Evinacumab 15mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: EvinacumabExperimental Treatment1 Intervention
Part A: Single intravenous (IV) dose Part B: IV dose every 4 weeks (Q4W) until week 20 Part C: IV dose Q4W
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evinacumab
2017
Completed Phase 3
~390

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
615 Previous Clinical Trials
379,814 Total Patients Enrolled
53 Trials studying Hypercholesterolemia
23,351 Patients Enrolled for Hypercholesterolemia
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
259 Previous Clinical Trials
251,024 Total Patients Enrolled
16 Trials studying Hypercholesterolemia
6,342 Patients Enrolled for Hypercholesterolemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any specific qualifications that make an individual ideal for this research project?

"20 young patients with homozygous familial hypercholesterolemia are needed for this clinical trial. Candidates between the ages of 5 and 11 years old who meet the following requirements are eligible to apply: Body weight ≥15 kg, Receiving stable maximally tolerated therapy*at the screening visit *Maximally tolerated therapy could include a daily statin., Willing and able to comply with clinic visits and study-related procedures."

Answered by AI

Has Evinacumab been cleared by the FDA?

"There is both anecdotal evidence and clinical data supporting Evinacumab's safety, so it received a score of 3."

Answered by AI

What are scientists and doctors hoping to learn from this clinical trial?

"The main metric that will be used to gauge the success of this medical intervention over the course of 24 weeks is the area under the concentration-time curve (AUC). Additionally,secondary outcomes like the percent change in total cholesterol (TC) from baseline to week 24, the proportion of patients with ≥50% reduction in calculated LDL-C at week 24, and the absolute change in LDL-C at week 24 will be used to supplement the primary outcome."

Answered by AI

What other research studies have included Evinacumab as a testing drug?

"Evinacumab is being trialed in 92 locations, with 3 of those trials currently active. Out of the three, 2 are in Phase 3."

Answered by AI

Does this research study hope to enroll participants who are over 45 years old?

"Children aged 5 to 11 may be eligible for this clinical trial, as indicated by the inclusion criteria. Out of the 72 total studies, 14 are for patients under 18 years old and 58 are for patients over 65."

Answered by AI

What earlier research has been conducted in this area?

"Evinacumab has been under investigation since 2018 when the first study, sponsored by Regeneron Pharmaceuticals, was completed with 116 participants. Evinacumab received Phase 3 drug approval after this initial study. Currently, there are 3 active studies involving Evinacumab being conducted in 57 cities spanning 14 countries."

Answered by AI
~4 spots leftby Apr 2025