A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old

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NCT06054893

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

Phase

Phase 1

Status

Active, not recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

33actual

Sites

Country

United States

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

2024-07-01

actual

When the study began enrolling

Primary completion

2025-09-30

actual

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

Study completion

2030-11-22

estimated

The whole study's end, after follow-up

First posted

2023-09-26

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-05-11

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

Intervention

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

Primary outcomes

what the primary-completion date above is the date OF

Part 1: Apparent Clearance (CL/F) of Omaveloxolone

measured Predose (0 hour), after dose 1 hour, 2 hours, 3 hours, 4 hours, 24 hours, and 96 hours

Part 1: Maximum Concentration (Cmax) of Omaveloxolone

measured Predose (0 hour), after dose 1 hour, 2 hours, 3 hours, 4 hours, 24 hours, and 96 hours

Part 1: Volume of Distribution (V/F) of Omaveloxolone

measured Predose (0 hour), after dose 1 hour, 2 hours, 3 hours, 4 hours, 24 hours, and 96 hours

Part 1: Area Under the Plasma Concentration-Time Curve From 0 Extrapolated to Infinity (AUC0-∞) of Omaveloxolone

measured Predose (0 hour), after dose 1 hour, 2 hours, 3 hours, 4 hours, 24 hours, and 96 hours

Part 1: Area Under the Plasma Concentration-Time Curve From 0 to tlast (AUC0-tlast) of Omaveloxolone

measured Predose (0 hour), after dose 1 hour, 2 hours, 3 hours, 4 hours, 24 hours, and 96 hours

Part 1: Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC0-24) of Omaveloxolone

measured Predose (0 hour), after dose 1 hour, 2 hours, 3 hours, 4 hours, 24 hours, and 96 hours

Part 1: Individual Steady-State AUC0-24 (AUC0-24,ss) of Omaveloxolone

measured Predose (0 hour), after dose 1 hour, 2 hours, 3 hours, 4 hours, 24 hours, and 96 hours

Part 1: Individual Steady-State Cmax (Cmax,ss) of Omaveloxolone

measured Predose (0 hour), after dose 1 hour, 2 hours, 3 hours, 4 hours, 24 hours, and 96 hours

Part 1: Concentration at the end of a 24-Hour Dosing Interval (Ctrough,ss) of Omaveloxolone

measured Predose (0 hour), after dose 1 hour, 2 hours, 3 hours, 4 hours, 24 hours, and 96 hours

Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

measured From Day 1 up to the end of study (up to Week 240)

Part 2: Number of Participants With Clinically Significant Abnormality in Clinical Laboratory Assessments