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RecruitingPhase 3NCT06672237

A Phase 3 Study of NTLA-2001 in ATTRv-PN

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)

Sponsor

Intellia Therapeutics

Enrollment

60 participants

Start Date

Nov 22, 2024

Study Type

INTERVENTIONAL

Conditions

Nervous system diseasePeripheral nervous system diseaseAmyloidosisNeuromuscular DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases (NMD)PolyneuropathiesMetabolic DiseasesNeurodegenerative DiseasesNeurodegenerative DiseaseNeurodegenerative Disease, HereditaryAmyloidosis, HereditaryAmyloidosis, FamilialMetabolism, Inborn ErrorsGenetic Disease, InbornNerve DisordersAmyloid NeuropathiesAmyloid Neuropathies, FamilialNeuromuscular disease

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Normal Saline as Placebo and a biological treatment called nexiguran ziclumeran for people with amyloid neuropathies, amyloid neuropathies, familial, and other related conditions. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALnexiguran ziclumeran

nexiguran ziclumeran 55 mg by single IV infusion

DRUGNormal Saline as Placebo

Normal saline (0.9% NaCl) by single IV infusion

Locations(14)

Hospital Británico de Buenos Aires

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires (HIBA)

Buenos Aires, Argentina

Hospital El Cruce

San Juan Bautista, Argentina

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

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, Taiwan

Siriraj Hospital

Bangkok, Thailand

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NCT06672237

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