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Antisense Oligonucleotide

Eplontersen for Amyloid Neuropathy

Phase 3
Recruiting
Research Sponsored by Ionis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willingness to adhere to vitamin A supplementation per protocol
Females must be non-pregnant and non-lactating and meet specific criteria related to surgical sterility, post-menopausal status, abstinence, or contraceptive use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 181
Awards & highlights

Study Summary

This trial will assess the safety of a new drug for a rare disease that causes nerve damage.

Who is the study for?
This trial is for adults with hereditary transthyretin-mediated amyloid polyneuropathy who have completed certain previous studies. Participants must agree to vitamin A supplementation, use contraception if fertile, and be able to follow study requirements. Pregnant or breastfeeding women are excluded.Check my eligibility
What is being tested?
The trial tests the long-term safety and effectiveness of Eplontersen in patients with hATTR-PN. It aims to understand how well patients tolerate extended dosing of this medication over a longer period.See study design
What are the potential side effects?
While specific side effects for Eplontersen aren't listed here, similar medications may cause injection site reactions, fatigue, nausea, headache, and potential liver issues. Monitoring will occur for any adverse effects during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to follow the vitamin A supplement plan.
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I am not pregnant or breastfeeding and follow specific birth control or sterility guidelines.
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I am a man following specific guidelines to prevent pregnancy during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 181
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 181 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Adverse Events
Change From Baseline in Body Weight
Change From Baseline in Number of Concomitant Medications Used
+10 more
Secondary outcome measures
Change From Baseline in 5 Level EQ-5D (EQ-5D-5L)
Change From Baseline in Composite Autonomic Symptom Score-31 (COMPASS-31)
Change From Baseline in Modified Body Mass Index (mBMI)
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: EplontersenExperimental Treatment1 Intervention
Eplontersen will be administered by subcutaneous (SC) injection once every 4 weeks for up to 3 years (157 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AKCEA-TTR-LRx
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor
145 Previous Clinical Trials
15,124 Total Patients Enrolled

Media Library

Eplontersen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05071300 — Phase 3
Transthyretin-Mediated Amyloid Polyneuropathy Research Study Groups: Eplontersen
Transthyretin-Mediated Amyloid Polyneuropathy Clinical Trial 2023: Eplontersen Highlights & Side Effects. Trial Name: NCT05071300 — Phase 3
Eplontersen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05071300 — Phase 3

Frequently Asked Questions

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

How many different medical clinics are managing this clinical trial today?

"There are 4 clinical trial sites operational at the moment, situated in Portland, Indianapolis and Boston as well as other cities. To cut down on travel, patients should enroll at the location that is closest to them."

Answered by AI

How many individuals are enrolled in this research project?

"One hundred and forty patients that fit the bill are needed for this experiment. Those chosen can come from multiple hospitals, such as Oregon Health and Science University in Portland, Oregon or Indiana University Health University Hospital in Indianapolis, Indiana."

Answered by AI

To your knowledge, does a similar study exist?

"3 trials for Eplontersen are ongoing in 88 cities and 25 countries. The first study was completed in 2020 by Ionis Pharmaceuticals, Inc. 168 individuals participated in the Phase 3 clinical trial which approved the drug. In the 2 years since then, 2 more studies have been conducted."

Answered by AI

Does Eplontersen have any dangerous side effects that we should know about?

"Eplontersen is backed by Phase 3 trial data, indicating that multiple rounds of testing support both its efficacy and safety."

Answered by AI

Are there any Eplontersen studies in the medical literature?

"Eplontersen was first studied in 2020 at Azienda Ospedaliera Universitaria Policlinico Gaetano Martino. There have been a total of 2 completed clinical trials since then. As of right now, 3 active trials are ongoing; a majority of these taking place in Portland, Oregon."

Answered by AI

Are new participants being recruited for this research project?

"The study, which was originally posted on clinicaltrials.gov on 1/4/2022 is still recruiting participants. The most recent edit to the posting occurred on 11/3/2022."

Answered by AI
~14 spots leftby Jul 2024