Hereditary Transthyretin-Mediated Amyloid PolyneuropathyPhase 3NCT05071300
A Study to Assess the Long-Term Safety and Efficacy of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
A Phase 3 study testing Eplontersen in people with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy, run by Ionis Pharmaceuticals, Inc. at 33 sites in 13 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
- What is being tested?
- Eplontersen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 33 sitesin 13 countries
- Study dates
- 4 Jan 2022to Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Satisfactory completion of ION-682884-CS3 (NCT04136184) (Index Study) as judged by the Investigator and Sponsor, or diagnosis of hATTR-PN and satisfactory completion of either study ISIS 420915-CS101 or study 2018-P001436 (NCT03702829) (both are Investigator-Sponsored studies with inotersen - the unconjugated version of eplontersen) as judged by the Investigator and Sponsor.
- Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
- Satisfy the following:
- Females: must be non-pregnant and non-lactating and either:
- Surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy);
- Post-menopausal (defined as 12 months of spontaneous amenorrhea in females > 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and follicle-stimulating hormone (FSH) levels in the postmenopausal range for the laboratory involved;
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- Abstinent*;
- If engaged in sexual relations of child-bearing potential, agree to use highly effective contraceptive methods from the time of signing the informed consent form until at least 24 weeks after the last dose of eplontersen and agree to receive pregnancy tests per protocol.
- Males: Surgically sterile (i.e., bilateral orchidectomy) or abstinent*, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), the participant or the participant's non-pregnant female partner must use a highly effective contraceptive method from the time of signing the informed consent form until at least 24 weeks after the last dose of eplontersen. *Abstinence (i.e., refraining from heterosexual intercourse throughout the duration of study participation) is only acceptable as true abstinence, i.e., when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial and withdrawal are not acceptable methods of contraception.
- Willingness to adhere to vitamin A supplementation per protocol.
Who cannot join
- 1. Have any new condition or worsening of existing condition that in the opinion of the Investigator or Sponsor would make the participant unsuitable for enrollment or could interfere with the participant taking part in or completing the study.
Trial locations and contacts
33 sites in 13 countries.
33 sites in 13 countries
United States8 sites
Johns Hopkins University Neurology Research Office
Baltimore, Maryland, 21287
Boston University School of Medicine
Boston, Massachusetts, 02118
University of North Carolina Hospitals - Neurology Clinic
Chapel Hill, North Carolina, 27514
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
The Neurological Institute of New York
New York, New York, 10032
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic
Scottsdale, Arizona, 85259
University of Washington Medical Center
Seattle, Washington, 98195
Brazil4 sites
Hospital Universitario Clementino Fraga Filho
Botafogo, Rio de Janeiro, 22281-100
Universidade Estadual de Campinas
Campinas, 13083-888
Instituto de Neurologia de Curitiba
Curitiba, 81210-310
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
São Paulo, 14051-140
Taiwan4 sites
China Medical University Hospital
Taichung, 40447
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Memorial Hospital
Taoyuan, 333
Argentina3 sites
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB
Instituto Fleni
Buenos Aires, C1428 AQK
Hospital El Cruce
San Juan Bautista, 1888
Canada2 sites
Toronto General Hospital
Toronto, Ontario, M5G2C4
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
France2 sites
Hôpital de la Timone
Marseille, 13385
Centre Hospitalier Universitaire de Toulouse
Toulouse, Haute-Garonne, 31059
Italy2 sites
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Carlo Besta
Milan, 20133
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Portugal2 sites
Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria
Lisbon, 1649-035
Centro Hospitalar Universitário do Porto - Hospital Geral de Santo Antonio
Porto, 4099-001
Spain2 sites
Hospital Clínico San Carlos
Madrid, 28040
Hospital Son Llàtzer
Palma de Mallorca, 07198
Australia1 site
Perron Institute for Neurological and Translational Science
Murdoch, Western Australia, 6150
Turkey (Türkiye)1 site
Istanbul Üniversitesi - Istanbul Tip Fakültesi
Istanbul, 34093
About this study
Official title: An Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN).
Read the detailed description
This is a multicenter, open-label, Phase 3 study in up to approximately 165 participants. Participants will also receive daily supplemental doses of the recommended daily allowance (RDA) of vitamin A. This study will consist of the following periods: less than or equal to (≤) 8-week screening period, a 157-week treatment period, and a 24-week post-treatment evaluation period.
Participants may continue to receive treatment in this study for up to 2 years or until ION-682884 becomes commercially available in the patient's country, whichever occurs earlier.
- Being tested
- Eplontersen
- Keywords
- ION-682884, hATTR-PN, TTR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplontersenDrug
Also called AKCEA-TTR-LRx, ION-682884, IONIS-TTR-LRx
Eplontersen will be administered by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Eplontersen | Experimental | Eplontersen will be administered by subcutaneous (SC) injection once every 4 weeks for up to 3 years (157 weeks). Receives: Drug: Eplontersen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Platelet Count
Measured: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Renal Function
Measured: Baseline to Week 181
Number of Participants with Clinically Significant Changes from Baseline in Transaminases
Measured: Baseline to Week 181
Change From Baseline in Adverse Events
Measured: Baseline to Week 181
Change From Baseline in Number of Concomitant Medications Used
Measured: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Measured: Baseline to Week 181
Change From Baseline in Body Weight
Measured: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
Measured: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Tests
Measured: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Parameters
Measured: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Thyroid Panel Tests
Measured: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Coagulation Tests
Measured: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Inflammatory Panel Tests
Measured: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Complement and Immunogenicity Tests
Measured: Baseline to Week 181
Secondary outcomes (9)
Change From Baseline in Neuropathy Impairment Score (NIS)
NIS is a composite, quantitative measure of both large-and small-fiber dysfunction used to evaluate the participant's muscle strength, sensation, and reflexes. Total NIS is graded on a scale of 0-244, with a higher score indicating greater impairment.
Measured: Baseline to Week 181
Change From Baseline in Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Questionnaire
The Norfolk QoL-DN score is a measure of physical function/large fiber neuropathy, symptoms, activities of daily living, small fiber neuropathy, and autonomic neuropathy. The Norfolk QoL-DN total score has a range of -4 to 136, and a higher score indicates poorer quality of life.
Measured: Baseline to Week 181
Change From Baseline in Neuropathy Symptom and Change Score (NSC)
NSC score is a questionnaire composed of 38 questions that assess the presence and severity of neuropathy symptoms (including weakness, loss of temperature and pain sensation, and manifestations associated with autonomic nervous system dysfunction).
Measured: Baseline to Week 181
Change From Baseline in Serum Transthyretin (TTR) Concentration
Measured: Baseline to Week 181
Change From Baseline in Physical Component Summary Score (PCS) of 36-Item Short Form Survey (SF-36)
The SF-36 is composed of 8 multi-item scales (35 items) assessing physical function (10 items), role limitations due to physical health problems (4 items), bodily pain (2 items), general health (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items) and emotional well-being (5 items). Each of the 8 scales is scored from 0 to 100 with higher scores indicating better health. The 8 scales can be aggregated into a PCS score, which is also scaled from 0 to 100 with higher scores indicating better health.
Measured: Baseline to Week 181
Change From Baseline in Polyneuropathy Disability Score (PND)
PND score assesses disease severity using a 5-stage scoring system. It includes Stage 0: no impairment; Stage 1: sensory disturbances but preserved walking capabilities; Stage 2: impaired walking capacity, but ability to walk without a stick or crutches; Stage 3A/B: walking with help of 1 or 2 sticks or crutches; Stage 4: confined to wheel chair or bedridden.
Measured: Baseline to Week 181
Change From Baseline in Modified Body Mass Index (mBMI)
mBMI is defined as body mass index in kilograms per square meter (kg/m^2) multiplied by serum albumin in grams per liter (g/L).
Measured: Baseline to Week 181
Change From Baseline in Composite Autonomic Symptom Score-31 (COMPASS-31)
COMPASS-31 is a 31-question participant-reported assessment that measures autonomic symptoms across 6 weighted domains on a 100-point scale: orthostatic intolerance (40 points), vasomotor (5 points), secretomotor (15 points), gastrointestinal (25 points), bladder (10 points), and pupillomotor (15 points). A higher score indicates worse autonomic dysfunction.
Measured: Baseline to Week 181
Change From Baseline in 5 Level EQ-5D (EQ-5D-5L)
The EQ-5D-5L is a standard measure of health-related quality of life. EQ-5D-5L consists of two components: a health state profile and a visual analog scale (VAS). EQ-5D health state profile comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where a higher score indicates a better health state. The VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine". Higher scores of EQ VAS indicate better health.
Measured: Baseline to Week 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start4 Jan 2022
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Transthyretin-Mediated Amyloid PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071300
- Sponsor's protocol ID
- ION-682884-CS13
- Other IDs
- 2024-511201-32-00
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
- ClinicalTrials.gov ID
- NCT05071300
- Acronym / sponsor ID
- ION-682884-CS13
- Keywords
- ION-682884, hATTR-PN, TTR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN).
Detailed description
This is a multicenter, open-label, Phase 3 study in up to approximately 165 participants. Participants will also receive daily supplemental doses of the recommended daily allowance (RDA) of vitamin A. This study will consist of the following periods: less than or equal to (≤) 8-week screening period, a 157-week treatment period, and a 24-week post-treatment evaluation period.
Participants may continue to receive treatment in this study for up to 2 years or until ION-682884 becomes commercially available in the patient's country, whichever occurs earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eplontersen | Experimental | Drug: EplontersenEplontersen will be administered by subcutaneous (SC) injection once every 4 weeks for up to 3 years (157 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Satisfactory completion of ION-682884-CS3 (NCT04136184) (Index Study) as judged by the Investigator and Sponsor, or diagnosis of hATTR-PN and satisfactory completion of either study ISIS 420915-CS101 or study 2018-P001436 (NCT03702829) (both are Investigator-Sponsored studies with inotersen - the unconjugated version of eplontersen) as judged by the Investigator and Sponsor.
- Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
- Satisfy the following:
- Willingness to adhere to vitamin A supplementation per protocol.
Key exclusion criteria (1 listed)
- 1. Have any new condition or worsening of existing condition that in the opinion of the Investigator or Sponsor would make the participant unsuitable for enrollment or could interfere with the participant taking part in or completing the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EplontersenAlso: AKCEA-TTR-LRx, ION-682884, IONIS-TTR-LRxEplontersen will be administered by SC injection. | Drug | Eplontersen |
Primary outcome
Change From Baseline in Platelet Count
Time frame: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Renal Function
Time frame: Baseline to Week 181
Number of Participants with Clinically Significant Changes from Baseline in Transaminases
Time frame: Baseline to Week 181
Change From Baseline in Adverse Events
Time frame: Baseline to Week 181
Change From Baseline in Number of Concomitant Medications Used
Time frame: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Time frame: Baseline to Week 181
Change From Baseline in Body Weight
Time frame: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
Time frame: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Tests
Time frame: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Thyroid Panel Tests
Time frame: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Coagulation Tests
Time frame: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Inflammatory Panel Tests
Time frame: Baseline to Week 181
Number of Participants With Clinically Significant Changes From Baseline in Complement and Immunogenicity Tests
Time frame: Baseline to Week 181
9 secondary outcomes
Change From Baseline in Neuropathy Impairment Score (NIS)
Time frame: Baseline to Week 181
Change From Baseline in Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Questionnaire
Time frame: Baseline to Week 181
Change From Baseline in Neuropathy Symptom and Change Score (NSC)
Time frame: Baseline to Week 181
Change From Baseline in Serum Transthyretin (TTR) Concentration
Time frame: Baseline to Week 181
Change From Baseline in Physical Component Summary Score (PCS) of 36-Item Short Form Survey (SF-36)
Time frame: Baseline to Week 181
Change From Baseline in Polyneuropathy Disability Score (PND)
Time frame: Baseline to Week 181
Change From Baseline in Modified Body Mass Index (mBMI)
Time frame: Baseline to Week 181
Change From Baseline in Composite Autonomic Symptom Score-31 (COMPASS-31)
Time frame: Baseline to Week 181
Change From Baseline in 5 Level EQ-5D (EQ-5D-5L)
Time frame: Baseline to Week 181
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Yes. Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eplontersen in people with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy, run by Ionis Pharmaceuticals, Inc. at 33 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Brazil, Taiwan, Argentina, Canada and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Platelet Count (time frame: Baseline to Week 181). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.