BOLDNCT06054893
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
At risk: Primary completion moved at least 4 years 8 months later.
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Record History
All 11 versions: 10 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗
- Notable Primary completion pushed from Sep 30, 2025 to Jun 4, 2030
- Study completion moved earlier from Nov 22, 2030 to Jun 4, 2030
- Notable Primary completion moved earlier from Feb 21, 2030 to Sep 30, 2025
- Trial status changed: Recruiting → Active, Not Recruiting
- Enrollment target: estimated 35 to confirmed 33
- Site details revised
- Minor Study completion date: Feb 21, 2030 to Nov 22, 2030v9
- Minor Study description shortened, about 17 wordsv7
Notable Enrollment target: 20 to 35v6 Show 4 more changesShow less
- Primary endpoints revised (20)
- Eligibility criteria expanded, about 2 words
- Study description revised
- Study arms: 4 to 7
Show 4 earlier versionsHide 4 earlier versions
- Notable Lead sponsor: Reata, a wholly owned subsidiary of Biogen to Biogen
- Study description expanded, about 65 words
- Site contact updated
- Study title expanded, about 22 words
- Notable Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Jul 22, 2024 to Jul 1, 2024
- Site details revised
Notable Lead sponsor: Biogen to Reata, a wholly owned subsidiary of Biogenv3 Show 6 more changesShow less
- Primary and study completion dates: Feb 1, 2024 to Feb 21, 2030
- Start date: Nov 1, 2023 to Jul 22, 2024
- Eligibility criteria shortened, about 69 words
- Primary endpoints: 6 to 20
- Secondary endpoints expanded, about 39 words
- Study description expanded, about 37 words
- Notable Lead sponsor: Reata Pharmaceuticals, Inc. to Biogen
- Primary and study completion dates: Feb 2024 to Feb 1, 2024
- Start date: Nov 2023 to Nov 1, 2023
- Study description expanded, about 19 words
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Secondary (4)
Arms and interventions
Cohort A1 will contain participants 12 to \<16 years of age. Participants will receive a single oral dose of omaveloxolone, 150 milligrams (mg), capsule, on Day 1 of the treatment period of part 1, followed by the same dose in part 2 up to when the last participant enrolled has the opportunity for their week 240. The dose in part 2 may be adjusted as per additional safety and Bayesian population pharmacokinetics (popPK) analyses.
Cohort A2 will contain participants 12 to \<16 years of age. Participants will receive a single oral dose of omaveloxolone, capsule, at a dosage level determined by a Bayesian popPK analysis using the data from Cohort A1 to select the dose in part 1, followed by the same dose in part 2 up to when the last participant enrolled has the opportunity for their week 240. The dose in part 2 may be adjusted as per additional safety and Bayesian popPK analyses.
Cohort B1 will contain participants 7 to \<12 years of age and will initiate in parallel with Cohort A2. Participants will receive a single oral dose of omaveloxolone, capsule, at a dosage level determined by a Bayesian popPK analysis using the data from Cohort A1 to select the dose in part 1, followed by the same dose in part 2 up to when the last participant enrolled has the opportunity for their week 240. The dose in part 2 may be adjusted as per additional safety and Bayesian popPK analyses.
Cohort C1 will contain participants 2 to \<7 years of age. Participants will receive a single oral dose of omaveloxolone, capsule, at a dosage level determined by a Bayesian popPK analysis using the data from cohorts A1, A2, and B1 to select the dose in part 1, followed by the same dose in part 2 up to when the last participant enrolled has the opportunity for their week 240. The dose in part 2 may be adjusted as per additional safety and Bayesian popPK analyses.
Cohort A3 will contain participants 12 to \<16 years of age. Participants will receive a single oral dose of omaveloxolone, capsule, at a dosage level determined by a Bayesian popPK analysis using the data from cohorts A1, A2, and B1 to select the dose in part 1, followed by the same dose in part 2 up to when the last participant enrolled has the opportunity for their week 240. The dose in part 2 may be adjusted as per additional safety and Bayesian popPK analyses.
Cohort B2 will contain participants 7 to \<12 years of age and will initiate in parallel with Cohort A3. Participants will receive a single oral dose of omaveloxolone, capsule, at a dosage level determined by a Bayesian popPK analysis using the data from cohorts A1, A2, and B1 to select the dose in part 1, followed by the same dose in part 2 up to when the last participant enrolled has the opportunity for their week 240. The dose in part 2 may be adjusted as per additional safety and Bayesian popPK analyses.
Cohort C2 will contain participants 2 to \<7 years of age. Participants will receive a single oral dose of omaveloxolone, capsule, at a dosage level determined by a Bayesian popPK analysis using the data from Cohorts A1, A2, A3, B1, B2, and C1 to select the dose in part 1, followed by the same dose in part 2 up to when the last participant enrolled has the opportunity for their week 240. The dose in part 2 may be adjusted as per additional safety and Bayesian popPK analyses.
Drugs: Omaveloxolone
Sites
1 site in 1 country
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania, United States