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A Phase 3 Study of NTLA-2001 in ATTRv-PN
Sponsor: Intellia Therapeutics
Summary
This study will be conducted to evaluate the efficacy and safety of a single dose of nexiguran ziclumeran (NTLA-2001) compared to placebo in participants with ATTRv-PN.
Official title: MAGNITUDE-2: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants With Hereditary Transthyretin Amyloidosis With Polyneuropathy (ATTRv-PN)
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-11-22
Completion Date
2028-08
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
nexiguran ziclumeran
nexiguran ziclumeran 55 mg by single IV infusion
Normal Saline as Placebo
Normal saline (0.9% NaCl) by single IV infusion
Locations (16)
Hospital Británico de Buenos Aires
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires (HIBA)
Buenos Aires, Argentina
Hospital El Cruce
San Juan Bautista, Argentina
Westmead Hospital
Westmead, Australia
Hospital das Clinicas da Universidade Estadual de Campinas (UNICAMP)
Campinas, Brazil
HCFMRP - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude
Rio de Janeiro, Brazil
PSEG Centro de Pesquisa Clinica S.A.
São Paulo, Brazil
National Institute of Medical Sciences and Nutrition - Salvador Zubiran (INCMNSZ)
Tlalpan, Mexico
New Zealand Clinical Research
Auckland, New Zealand
National University Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation - Linkou Branch
Taoyuan District, Taiwan
Siriraj Hospital
Bangkok, Thailand