A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's Ataxia

← catalyst calendar

NCT06953583 · readout in 454 d

Sponsored by Biogen (industry) · BIIB — their whole pipeline →.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

255estimated

Sites

Countries

Australia, Austria, Brazil +13

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-06-09

actual

When the study began enrolling

Primary completion

2027-11-16

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2029-11-22

estimated

The whole study's end, after follow-up

First posted

2025-05-01

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-06-16

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Friedreich Ataxia

Interventions

Drug: Omaveloxolone — also filed as BIIB141, SKYCLARYS, RTA-408
Drug: Placebo

Primary outcomes

what the primary-completion date above is the date OF

Part 1: Change From Baseline in Upright Stability Score (USS) Subscale E of Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 52

measured Baseline, Week 52

Part 2A: Change From Baseline in USS Subscale E of mFARS at Week 52

measured Baseline (Week 52 of Part 1), Week 52

Part 2B: Number of Participants With Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (TESAE)

measured From the first dose of the study drug in Part 2B up to the end of follow-up period in Part 2B (up to Week 104)

Part 2B: Number of Participants With Change From Baseline in Cardiac Function Assessed by Echocardiogram (ECHO) at Weeks 52 and Week 104