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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 192 weeks
Awards & highlights

Study Summary

This trial will study the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH), as well as its effect on lipid parameters. The trial will also study the same in adolescent patients with HoFH, in order to evaluate the potential development of anti-evinacumab antibodies.

Eligible Conditions
  • Familial Hypercholesterolemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 192 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 192 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Absolute change in Apo B over time
Absolute change in LDL-C over time
Absolute change in TC over time
+8 more

Side effects data

From 2020 Phase 3 trial • 65 Patients • NCT03399786
16%
Nasopharyngitis
11%
Influenza like illness
9%
Headache
7%
Rhinorrhoea
5%
Toothache
2%
Urosepsis
2%
Suicide attempt
2%
Nausea
2%
Back pain
2%
Asthma
2%
Gastroenteritis viral
2%
Constipation
2%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo IV Q4W (DBTP)
Evinacumab 15 mg/kg (DBTP)
Placebo IV Q4W (OLTP)
Evinacumab 15 mg/kg (OLTP)

Trial Design

1Treatment groups
Experimental Treatment
Group I: evinacumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
evinacumab
2018
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
613 Previous Clinical Trials
379,642 Total Patients Enrolled
53 Trials studying Hypercholesterolemia
23,255 Patients Enrolled for Hypercholesterolemia
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
258 Previous Clinical Trials
250,882 Total Patients Enrolled
16 Trials studying Hypercholesterolemia
6,246 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.

How many individuals are being included in this research project?

"Enrollment for this trial has already closed. The listing was first posted on March 13th, 2018 and updated for the final time on November 9th, 2022. Currently, there are 75 clinical trials actively recruiting patients with hypercholesterolemia and 3 studies involving evinacumab that are still seeking participants."

Answered by AI

What other scientific papers have been published on evinacumab research?

"The first evinacumab clinical trials were completed in 2018. To date, there have been a total of 7 studies with 3 more currently recruiting patients. A high concentration of these active trials are taking place in Dallas, Texas."

Answered by AI

Are there any available positions for participants in this clinical trial?

"The latest information available on clinicaltrials.gov indicates that this study is not recruiting at this moment in time. The trial was first posted on March 13th, 2018 and was last updated on November 9th, 2020. There are 78 other studies that are currently looking for participants."

Answered by AI

What are the possible health consequences associated with evinacumab?

"There is some efficacy data and multiple rounds of safety data, so Power has estimated that evinacumab ranks a 3 on the 1-3 scale."

Answered by AI

Is this trial taking place at more than one location within the United States?

"Currently, this study is being conducted at 10 different sites; however, the majority of these locations are in major metropolitan areas. The cities with participating clinical trial sites include Dallas, Philadelphia and Boston. If you enroll in this trial, it would be beneficial to choose a location that is close to reduce travel requirements."

Answered by AI

Has a study like this ever been done before?

"Evinacumab has undergone clinical trials since 2018, with the first being sponsored by Regeneron Pharmaceuticals. This initial study had 116 participants. After this Phase 3 trial, evinacumab received drug approval and there are now 3 active trials in 14 countries across 57 cities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
2018. "Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03409744.
~16 spots leftby Apr 2025
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