A Study to Learn More About the Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Who Are Prescribed it by Their Own Doctors
← catalyst calendarNCT06623890 · readout in 1,139 d
Sponsored by Biogen (industry) · BIIB — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
300estimated
Sites
14
Countries
Austria, Belgium, Czechia +4
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 | 2024-12-12 | actual | When the study began enrolling |
| Primary completion | 2029-10-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-10-01 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-28 | 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 SKYCLARYS, BIIB141
Primary outcomes
what the primary-completion date above is the date OFOmaveloxolone Naive Cohort: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
measured From the start of the treatment up to end of the study (up to 5 years)
Omaveloxolone Non-Naive Cohort: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
measured From enrolment in the current study up to end of the study (up to 5 years)
Omaveloxolone Naive Cohort: Number of Participants With DILI and CHF AEs
measured From the start of the treatment up to end of the study (up to 5 years)
Omaveloxolone Non-Naive Cohort: Number of Participants With DILI and CHF AE
measured From enrolment in the current study up to end of the study (up to 5 years)
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