RecruitingPhase 3NCT07778836

A Study to Evaluate the Efficacy and Safety of Subcutaneous Nomlabofusp in Subjects With Friedreich's Ataxia

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Nomlabofusp in Subjects With Friedreich's Ataxia


Sponsor

Larimar Therapeutics, Inc.

Enrollment

150 participants

Start Date

Aug 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of subcutaneous nomlabofusp in adult and pediatric subjects with Friedreich's ataxia


Eligibility

Min Age: 12 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Nomlabofusp and a drug called Placebo for people with friedreich ataxia and friedreich's ataxia. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 12 Years to 40 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

DRUGNomlabofusp

Nomlabofusp is a recombinant fusion protein provided in a sterile, preservative-free buffered solution for subcutaneous injection intended to deliver human frataxin, the protein deficient in Friedreich's ataxia.

DRUGPlacebo

The placebo is a sterile, preservative-free, clear liquid for subcutaneous injection.


Locations(3)

Northwestern Medical Group, Department of Neurology

Chicago, Illinois, United States

Clinilabs

Eatontown, New Jersey, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07778836


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