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)
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Diagnosis of ATTRv-PN
• Karnofsky Performance Status (KPS) ≥ 60
Locations
Other Locations
Argentina
Hospital Británico de Buenos Aires
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires (HIBA)
RECRUITING
Buenos Aires
Hospital El Cruce
RECRUITING
San Juan Bautista
Australia
Westmead Hospital
RECRUITING
Westmead
Brazil
Hospital das Clinicas da Universidade Estadual de Campinas (UNICAMP)
RECRUITING
Campinas
HCFMRP - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
RECRUITING
Ribeirão Preto
Instituto de Educacao, Pesquisa e Gestao em Saude
RECRUITING
Rio De Janeiro
PSEG Centro de Pesquisa Clinica S.A.
RECRUITING
São Paulo
Mexico
National Institute of Medical Sciences and Nutrition - Salvador Zubiran (INCMNSZ)
RECRUITING
Tlalpan
New Zealand
New Zealand Clinical Research
RECRUITING
Auckland
Singapore
National University Hospital
RECRUITING
Singapore
Singapore General Hospital
RECRUITING
Singapore
Taiwan
National Taiwan University Hospital
ACTIVE_NOT_RECRUITING
Taipei
Taipei Veterans General Hospital
ACTIVE_NOT_RECRUITING
Taipei
Chang Gung Medical Foundation - Linkou Branch
ACTIVE_NOT_RECRUITING
Taoyuan District
Thailand
Siriraj Hospital
RECRUITING
Bangkok
Contact Information
Primary
Trial Manager at Intellia
medicalinformation@intelliatx.com
1-857-285-6200
Time Frame
Start Date: 2024-11-22
Estimated Completion Date: 2028-08
Participants
Target number of participants: 50
Treatments
Experimental: nexiguran ziclumeran
nexiguran ziclumeran 55 mg by single IV infusion
Placebo_comparator: Normal Saline
Placebo; Normal saline (0.9% NaCl) by single IV infusion
Related Therapeutic Areas
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Intellia Therapeutics