Clinical trial • Phase III • Neurology|Rare Disease

NUCRESIRAN for Hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN)

Phase III trial of NUCRESIRAN for Hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN).

Overview

Trial Therapeutic Area
Neurology|Rare Disease
Trial Disease
Hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN)
Trial Stage
Phase III
Drug Modality
Oligonucleotide
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
20-10-2025
First CTIS Authorization Date
20-02-2026

Trial design

Randomised, open-label, vutrisiran (amvuttra) 25 mg subcutaneous every 3 months (comparator arm as stated).-controlled Phase III trial in Portugal, France, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Vutrisiran (Amvuttra) 25 mg subcutaneous every 3 months (comparator arm as stated).
Target Sample Size
100
Trial Duration For Participant
1460

Eligibility

Recruits 100 Vulnerable population selected (isVulnerablePopulationSelected = true). The trial enrols adults only (age 18 or age of legal consent to 85). Participants must be able to understand, be willing and able to comply with study requirements and provide written informed consent (see inclusion criterion 6). Subject information and informed consent forms (Main ICF) and related ICFs (pregnancy, newborn, partner consent, data protection notices) are provided in country/language-specific versions..

Pregnancy Exclusion
29. Female patient who is pregnant or breastfeeding
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). The trial enrols adults only (age 18 or age of legal consent to 85). Participants must be able to understand, be willing and able to comply with study requirements and provide written informed consent (see inclusion criterion 6). Subject information and informed consent forms (Main ICF) and related ICFs (pregnancy, newborn, partner consent, data protection notices) are provided in country/language-specific versions.

Inclusion criteria

  • {"criterion_text":"- 1. Male or female age 18 (or age of legal consent) to 85 years, inclusive, at the time of initial informed consent.\n- 2. Have a diagnosis of hATTR amyloidosis with polyneuropathy with a documented TTR gene variant\n- 3. Have a neuropathy impairment score (NIS) of 5 to 130 (inclusive; this criterion must be met at the Baseline Visit 2)\n- 4. Have a Polyneuropathy Disability (PND) score of ≤3b (this criterion must be met at the Baseline Visit 2)\n- 5. Have a Karnofsky Performance Status (KPS) of ≥60%Informed Consent\n- 6. Patient is able to understand and is willing and able to comply with the study requirements and to provide written informed consent."}

Exclusion criteria

  • {"criterion_text":"- 1. All exclusion criteria can be found in the protocol (Section 4.2). 1. Has had a liver transplant or is likely, in the opinion of the Investigator, to undergo liver transplantation during the Treatment Period of the study\n- 18. Has uncontrolled clinically significant cardiac arrhythmia or unstable angina\n- 19. Has known type 1 diabetes\n- 10. Received prior or currently receiving TTR-lowering therapy\n- 20. Has had type 2 diabetes mellitus for ≥5 years\n- 21. Has untreated hypo- or hyperthyroidism\n- 22. Has had a major surgery within the past 3 months or has a major surgery planned during the study through Month 18\n- 23. Has an active infection requiring systemic antiviral, antiparasitic, or antimicrobial therapy that will not be completed prior to dosing (Day 1)\n- 24. Has other medical conditions or comorbidities which, in the opinion of the Investigator, could interfere with study compliance or data interpretation\n- 25. Has a history of multiple drug allergies or history of allergic reactions to any component of or excipient in the study drug\n- 26. Has a history of intolerance to SC injection(s)\n- 7. Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2 (calculation will be based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation; refer to Section 10.1)\n- 11. Is currently taking tafamidis, acoramidis, doxycycline, or tauroursodeoxycholic acid; if previously on any of these agents, must have completed a 14-day washout prior to dosing (Day 1)\n- 12. Is currently taking diflunisal; if previously on this agent, must have completed a 3-day washout prior to dosing (Day 1)\n- 2. Has known other (non-hATTR) forms of amyloidosis or clinical evidence of leptomeningeal amyloidosis\n- 3. Has a New York Heart Association (NYHA) heart failure classification >2\n- 4. Has any of the following laboratory parameter assessments at screening: a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 upper limit of normal (ULN) reference range b. Total bilirubin >1.5 ULN (>2 ULN in patients with Gilbert's Syndrome) c. International normalized ratio (INR) >2.0\n- 5. Platelet count <50,000/µL\n- 6. Absolute neutrophil count <1500 cells/mm³\n- 27. Has a life expectancy of <2 years based on Investigator's clinical judgement\n- 28. Is not willing to comply with the contraceptive requirements during the study period as described in Section 5.9.1\n- 29. Female patient who is pregnant or breastfeeding\n- 8. Has vitamin B12 levels below the lower limit of normal\n- 30. Unwilling or unable to limit alcohol consumption throughout the course of the study\n- 31. History of alcohol use disorder within the last 12 months before screening in the opinion of the Investigator\n- 32. History of illicit substance use within the past 5 years that in the opinion of the Investigator would interfere with compliance with study procedures or follow-up visits\n- 9. Has known human immunodeficiency virus infection; or evidence of acute or chronic hepatitis C virus or hepatitis B virus infection\n- 13. Anticipated to start an approved TTR stabilizing therapy (eg, tafamidis or acoramidis) within the first 18 months following randomization\n- 14. Received prior anti-TTR antibody treatment (ie, “TTR depleters”)\n- 15. Received an investigational agent within the last 30 days (or 5 half-lives of the investigational drug, whichever is longer), or are currently in follow-up of another clinical study. Any agent that has received health agency authorization (including for emergency use) by local or regional authorities is not considered investigational\n- 16. Has other known causes of sensorimotor or autonomic neuropathy (eg, autoimmune disease, monoclonal gammopathy) that the treating physician believes to be contributing to the neuropathy\n- 17. Had acute coronary syndrome within the past 3 months"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline in the Modified Neuropathy Impairment Score +7 (mNIS+7) compared to the external placebo group from the APOLLO study at Month 9","definition_or_measurement_approach":"Change from baseline in mNIS+7 measured at Month 9 and compared against an external placebo group derived from the APOLLO study."}

Secondary endpoints

  • {"endpoint_text":"- 1. Change from baseline in Norfolk Quality of Life Diabetic Neuropathy (Norfolk QoL-DN) total score compared to the external placebo group from the APOLLO study at Month 9","definition_or_measurement_approach":"Change from baseline in Norfolk QoL-DN total score measured at Month 9 compared to external APOLLO placebo group."}
  • {"endpoint_text":"- 2. Percent reduction in serum TTR levels in the nucresiran group compared to the in-study vutrisiran group through Month 9","definition_or_measurement_approach":"Percent reduction in serum transthyretin (TTR) concentration in nucresiran arm versus in-study vutrisiran arm through Month 9; measured via serum assays."}
  • {"endpoint_text":"- 3. Change from baseline in modified body mass index (mBMI) compared to the external placebo group from the APOLLO study at Month 9","definition_or_measurement_approach":"Change from baseline in mBMI at Month 9 compared to external APOLLO placebo group."}
  • {"endpoint_text":"- 4. Change from baseline in the following parameters compared to the external placebo group from the APOLLO study at Month 18: o mNIS+7; o Norfolk QoL-DN total score; o mBMI; o Rasch-built Overall Disability Scale R-ODS; o Timed 10-meter walk test (10-MWT)","definition_or_measurement_approach":"Change from baseline at Month 18 for listed clinical and functional measures (mNIS+7, Norfolk QoL-DN, mBMI, R-ODS, 10-MWT) compared to external APOLLO placebo group; each measured using the respective validated instrument or timed test."}
  • {"endpoint_text":"- 5. Percent reduction in serum TTR levels in the nucresiran group compared to the in-study vutrisiran group through Month 18","definition_or_measurement_approach":"Percent reduction in serum TTR in nucresiran arm versus in-study vutrisiran arm through Month 18."}
  • {"endpoint_text":"- 6. Percent reduction in serum TTR levels in the nucresiran group compared to the in-study vutrisiran group at Week 6","definition_or_measurement_approach":"Percent reduction in serum TTR in nucresiran arm versus in-study vutrisiran arm measured at Week 6."}

Recruitment

Digital Remote Recruitment
True, recruitment and participant engagement via Proofpilot patient and site engagement portal, Neonstone virtual platform for patient/site engagement and recruitment tracking, online trial posting/social imagery and registration postcards referenced in recruitment materials.
Planned Sample Size
100
Recruitment Window Months
53
Consent Approach
Participants must provide written informed consent (inclusion criterion requires ability to provide written informed consent). Main informed consent forms and related ICFs (pregnancy, newborn, partner consent, data protection notices, optional future research consents) are provided in country- and language-specific versions (examples in Portuguese, French, Greek, German, English, Italian, Spanish, Swedish). Consent is obtained from the participant (adults only; age 18 or age of legal consent).

Methods

  • Country-specific recruitment materials: Patient Information Brochures, Visual Talking Points, HCP Fact Cards, GP Letters, Study Visit Guides and Trial Posting Information (K1/K2 recruitment-arrangements documents) distributed in multiple country/language versions.
  • Digital participant engagement platforms: Patient and Site Engagement Portal (Proofpilot Inc.) and a virtual platform for patient and site engagement and recruitment tracking (Neonstone Limited).
  • Site-based recruitment via participating hospitals and neurology clinics (trial sites listed per country).
  • Printed recruitment items and outreach: Registration postcards, Post-It pads, Retention/Visit reminders and Trial social imagery for trial posting.

Geography

Total Number Of Sites
25
Total Number Of Participants
86

Portugal

Earliest CTIS Part Ii Submission Date
12-11-2025
Latest Decision Or Authorization Date
25-02-2026
Processing Time Days
105
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Unidade Local de Saúde de Santa Maria - Hopital de Santa Maria
Principal Investigator Name
Isabel Conceição
Principal Investigator Email
imsconceicao@gmail.com
Contact Person Name
Isabel Conceição
Contact Person Email
imsconceicao@gmail.com
Site Name
Unidade Local de Saúde de Santo António - Hospital de Santo António
Principal Investigator Name
Teresa Coelho
Contact Person Name
Teresa Coelho

France

Earliest CTIS Part Ii Submission Date
10-02-2026
Latest Decision Or Authorization Date
25-02-2026
Processing Time Days
15
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Département de Neurologie
Principal Investigator Name
Violaine PLANTE-BORDENEUVE
Principal Investigator Email
violaine.plante@aphp.fr
Contact Person Name
Violaine PLANTE-BORDENEUVE
Contact Person Email
violaine.plante@aphp.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Centre de référence des Maladies neuromusculaires et de la SLA
Principal Investigator Name
Shahram ATTARIAN
Principal Investigator Email
shahram.attarian@ap-hm.fr
Contact Person Name
Shahram ATTARIAN
Contact Person Email
shahram.attarian@ap-hm.fr
Site Name
Bicetre Hospital
Department Name
CRMR Neurologie Adultes
Principal Investigator Name
Andoni ECHANIZ-LAGUNA
Principal Investigator Email
andoni.echaniz-laguna@aphp.fr
Contact Person Name
Andoni ECHANIZ-LAGUNA
Contact Person Email
andoni.echaniz-laguna@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
11-12-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
75
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Department of Neurology
Principal Investigator Name
Markus Weiler
Principal Investigator Email
markus.weiler@med.uni-heidelberg.de
Contact Person Name
Markus Weiler
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Kardiologie Angologie und Intensivmedizin
Principal Investigator Name
Katrin Hahn
Principal Investigator Email
katrin.hahn@charite.de
Contact Person Name
Katrin Hahn
Contact Person Email
katrin.hahn@charite.de
Site Name
Universitaet Muenster
Department Name
Medizinische Klinik B (Gastroenterologie, Hepatologie, Endokrinologie, Klinische Infektiologie)
Principal Investigator Name
Michael Praktiknjo
Principal Investigator Email
Michael.Praktiknjo@ukmuenster.de
Contact Person Name
Michael Praktiknjo

Greece

Earliest CTIS Part Ii Submission Date
12-11-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
104
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
General Hospital Of Athens Alexandra
Department Name
Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics
Principal Investigator Name
Efstathios Kastritis
Principal Investigator Email
ekastritis@gmail.com
Contact Person Name
Efstathios Kastritis
Contact Person Email
ekastritis@gmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Neurology Department
Principal Investigator Name
Ioannis Zaganas
Principal Investigator Email
johnzag@yahoo.com
Contact Person Name
Ioannis Zaganas
Contact Person Email
johnzag@yahoo.com

Ireland

Earliest CTIS Part Ii Submission Date
08-01-2026
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
50
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Tallaght University Hospital
Department Name
Neurology
Principal Investigator Name
Sinead Murphy
Principal Investigator Email
Sinead.murphy@tuh.ie
Contact Person Name
Sinead Murphy
Contact Person Email
Sinead.murphy@tuh.ie

Italy

Earliest CTIS Part Ii Submission Date
29-01-2026
Latest Decision Or Authorization Date
25-02-2026
Processing Time Days
27
Number Of Sites
6
Number Of Participants
25

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Neurologia
Principal Investigator Name
Marco Luigetti
Principal Investigator Email
marco.luigetti@policlinicogemelli.it
Contact Person Name
Marco Luigetti
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
UOC Neurologia D'Urgenza, Padiglione 25 CTO
Principal Investigator Name
Alessandro Barilaro
Principal Investigator Email
alessandro.barilaro@unifi.it
Contact Person Name
Alessandro Barilaro
Contact Person Email
alessandro.barilaro@unifi.it
Site Name
Azienda Ospedaliera di Padova
Department Name
UOC Clinica Neurologica, ground floor Palazzina di Neuroscienze B1
Principal Investigator Name
Chiara Briani
Principal Investigator Email
chiara.briani@unipd.it
Contact Person Name
Chiara Briani
Contact Person Email
chiara.briani@unipd.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
Department of Clinical and Experimental Medicine, University of Messina
Principal Investigator Name
Massimo Russo
Principal Investigator Email
russom@unime.it
Contact Person Name
Massimo Russo
Contact Person Email
russom@unime.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
U.O.C. Medicina Gen 2- Centro Amiloidosi Sistemiche e Malattie ad Alta Complessità
Principal Investigator Name
Laura Piera Obici
Principal Investigator Email
l.obici@smatteo.pv.it
Contact Person Name
Laura Piera Obici
Contact Person Email
l.obici@smatteo.pv.it
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
Clinical Neurology, Head of Rare Neurological Diseases Unit
Principal Investigator Name
Davide Pareyson
Principal Investigator Email
davide.pareyson@istituto-besta.it
Contact Person Name
Davide Pareyson

Spain

Earliest CTIS Part Ii Submission Date
22-01-2026
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
36
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Bellvitge University Hospital
Department Name
Neurology
Principal Investigator Name
Carlos Casasnovas Pons
Contact Person Name
Carlos Casasnovas Pons
Site Name
Hospital Clinico San Carlos
Department Name
Neurology
Principal Investigator Name
Lucía Galán Dávila
Principal Investigator Email
lgalan@salud.madrid.org
Contact Person Name
Lucía Galán Dávila
Contact Person Email
lgalan@salud.madrid.org
Site Name
Hospital Universitario Juan Ramon Jimenez
Department Name
Internal Medicine
Principal Investigator Name
Francisco Muñoz Beamud
Principal Investigator Email
eecc.amiloidosis.hujrj@fabis.org
Contact Person Name
Francisco Muñoz Beamud
Site Name
Hospital Universitari Vall D Hebron
Department Name
Internal Medicine
Principal Investigator Name
Fernando Martínez Valle
Principal Investigator Email
Fernando.martinez@vallhebron.cat
Contact Person Name
Fernando Martínez Valle
Site Name
Hospital Son Llatzer
Department Name
Internal Medicine
Principal Investigator Name
Inés Asunción Losada López
Principal Investigator Email
ialosada@hsll.es
Contact Person Name
Inés Asunción Losada López
Contact Person Email
ialosada@hsll.es

Sweden

Earliest CTIS Part Ii Submission Date
12-11-2025
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
100
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Region Stockholm – SLSO
Department Name
Studieenheten Akademiskt specialistcentrum, Dalagatan 9, 11361 Stockholm
Principal Investigator Name
Kristin Samuelsson
Principal Investigator Email
kristin.samuelsson@regionstockholm.se
Contact Person Name
Kristin Samuelsson
Site Name
Region Vaesterbotten
Department Name
Norrlands Universitetssjukhus,Medicin Centrum E41,Amyloidos Centrum, Försörjningsvägen 1C 90185 Umea
Principal Investigator Name
Jonas Wixner
Principal Investigator Email
jonas.wixner@umu.se
Contact Person Name
Jonas Wixner
Contact Person Email
jonas.wixner@umu.se

Cyprus

Earliest CTIS Part Ii Submission Date
20-02-2026
Latest Decision Or Authorization Date
06-03-2026
Processing Time Days
14
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
The Cyprus Foundation For Muscular Dystrophy Research
Department Name
Neuroepidemiology Department and EMG (Electromyography) Laboratory
Principal Investigator Name
Eleni Zamba Papanicolaou
Principal Investigator Email
ezamba@cing.ac.cy
Contact Person Name
Eleni Zamba Papanicolaou
Contact Person Email
ezamba@cing.ac.cy

Sponsor

Primary sponsor

Full Name
Alnylam Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
Operational / clinical trial services (sponsorDuties code: 8)
Name
PPD Global Ltd.
Responsibilities
Project management duties or monitoring/regulatory
Name
PPD Development LP
Responsibilities
Multiple operational roles (codes: 1,10,11,12,13,2,5,6,7,8,9) as listed in sponsorDuties
Name
Pharmaceutical Product Development LLC
Responsibilities
Laboratory Logistics and other operational support
Name
Advanced Clinical LLC
Responsibilities
Operational support (sponsorDuties code: 6)
Name
Suvoda LLC
Responsibilities
Operational services (sponsorDuties code: 3)

Third parties

  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Centogene GmbH","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Neonstone Limited","duties_or_roles":"Virtual platform for patient and site engagament, recruitment tracking","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"Home Nursing","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"The Brigham And Women’s Hospital Inc.","duties_or_roles":"Central Medical Reading of subjects' imaging (ECHO imaging reading)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Proofpilot Inc.","duties_or_roles":"Patient and Site Engagement Portal","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Project management duties or monitoring/regulatory","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Mayo Clinic Hospital Rochester","duties_or_roles":"Central Medical Reading of subjects' NIS, mNIS+7 assessment","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Advanced Clinical LLC","duties_or_roles":"sponsorDuties codes: 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Aliri USA Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,2,5,6,7,8,9 (multiple operational roles listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Laboratory Logistics; sponsorDuties codes: 15 and 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient travel and reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"Central Medical Reading of subjects' imaging (ECG imaging reading)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Aliri USA Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
ALN-TTRSC04
Active Substance
NUCRESIRAN
Modality
Oligonucleotide
Routes Of Administration
Solution for injection in pre-filled syringe (subcutaneous injection per protocol)
Route
Subcutaneous
Authorisation Status
Investigational (no marketing authorisation indicated in product dictionary)
Starting Dose
300 mg
Dose Levels
300 mg
Frequency
Every 6 months
Investigational Product Name
Amvuttra 25 mg solution for injection in pre-filled syringe
Active Substance
VUTRISIRAN
Modality
Oligonucleotide
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised in EU (marketing authorisation number EU/1/22/1681/001 listed)
Orphan Designation
Yes
Starting Dose
25 mg
Dose Levels
25 mg
Frequency
Every 3 months

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