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Conditions: Breast Cancer
Interventions: Omaveloxolone Lotion 0.5%, Omaveloxolone Lotion 3%, Vehicle Lotion, 3D conformal radiation therapy; Drug · Radiation
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 75 Years · Female only
Enrollment: 187 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2015
U.S. locations: 27
States / cities: Mesa, Arizona • Phoenix, Arizona • Scottsdale, Arizona + 23 more

Conditions: Melanoma, Unresectable (Stage III) Melanoma, Metastatic (Stage IV) Melanoma
Interventions: Omaveloxolone Capsules (2.5 mg/capsule), Ipilimumab (3 mg/kg), Nivolumab (240 mg), Omaveloxolone Capsules (10 mg/capsule), Omaveloxolone Capsules (50 mg/capsule); Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years and older
Enrollment: 41 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2018
U.S. locations: 10
States / cities: Mobile, Alabama • Fayetteville, Arkansas • Aurora, Colorado + 7 more

Conditions: MItochondrial Myopathies
Interventions: Omaveloxolone capsules, 2.5 mg, omaveloxolone capsules, 5 mg, omaveloxolone capsules, 10 mg, Placebo capsules, omaveloxolone capsules, 20 mg, omaveloxolone capsules, 40 mg, omaveloxolone capsules, 80 mg, omaveloxolone capsules, 160 mg; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 75 Years
Enrollment: 53 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2015 – 2017
U.S. locations: 8
States / cities: Los Angeles, California • Boston, Massachusetts • Akron, Ohio + 4 more

Conditions: Friedreich Ataxia
Interventions: Omaveloxolone Capsules, 2.5 mg, Omaveloxolone Capsules, 5 mg, Omaveloxolone Capsules, 10 mg, Placebo, Omaveloxolone Capsules, 20 mg, Omaveloxolone Capsules, 40 mg, Omaveloxolone Capsules, 80 mg, Omaveloxolone Capsules, 160 mg, Omaveloxolone Capsules, 300 mg, Omaveloxolone Capsules, 150 mg; Drug
Lead sponsor: Biogen; Industry
Eligibility: 16 Years to 40 Years
Enrollment: 172 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2015 – 2025
U.S. locations: 7
States / cities: Los Angeles, California • Gainesville, Florida • Tampa, Florida + 4 more

Conditions: Corneal Endothelial Cell Loss, Ocular Pain, Ocular Inflammation, Cataract Surgery
Interventions: Vehicle Ophthalmic Solution, Omaveloxolone Ophthalmic Suspension 0.5%, Omaveloxolone Ophthalmic Suspension 1%; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 80 Years
Enrollment: 307 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2015
U.S. locations: 15
States / cities: Laguna Hills, California • Lancaster, California • Cape Coral, Florida + 11 more

Conditions: Healthy
Interventions: omaveloxolone; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 55 Years
Enrollment: 32 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2018
U.S. locations: 1
States / cities: Cincinnati, Ohio

Conditions: Healthy
Interventions: RTA 408 Lotion 0.5%, 1%, 3%, Lotion vehicle/placebo; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 65 Years
Enrollment: 109 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2013 – 2014
U.S. locations: 1
States / cities: Cincinnati, Ohio

Conditions: Friedreich Ataxia
Interventions: Omaveloxolone, Placebo; Drug
Lead sponsor: Biogen; Industry
Eligibility: 2 Years to 15 Years
Enrollment: 255 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2025 – 2029
U.S. locations: 7
States / cities: Los Angeles, California • Gainesville, Florida • Tampa, Florida + 4 more

Conditions: Inflammation and Pain Following Ocular Surgery
Interventions: Omaveloxolone Ophthalmic Suspension 1.0%, Omaveloxolone Opthalmic Suspension 0.5%, Placebo; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years and older
Enrollment: 109 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014
U.S. locations: 6
States / cities: Garden Grove, California • Fort Myers, Florida • Kansas City, Missouri + 3 more

Conditions: Metastatic or Incurable Non-small Cell Lung Cancer, Relapsed, Refractory Melanoma
Interventions: omaveloxolone; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 75 Years
Enrollment: 11 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2013 – 2015
U.S. locations: 1
States / cities: Tampa, Florida

Conditions: Friedreich Ataxia
Interventions: Omaveloxolone; Drug
Lead sponsor: Biogen; Industry
Eligibility: 16 Years and older
Enrollment: 300 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2029
U.S. locations: 4
States / cities: Los Angeles, California • Aurora, Colorado • Gainesville, Florida + 1 more

Conditions: Healthy Adult Subjects
Interventions: Omaveloxolone, Midazolam oral solution, Repaglinide 1 MG, MetFORMIN 500 Mg Oral Tablet, Rosuvastatin, Digoxin tablet, Gemfibrozil Tablets, Itraconazole capsule, Verapamil Pill; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 55 Years
Enrollment: 61 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2019
U.S. locations: 1
States / cities: Dallas, Texas

Conditions: Healthy Volunteer
Interventions: Omaveloxolone; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 55 Years
Enrollment: 70 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2025 – 2026
U.S. locations: 1
States / cities: Austin, Texas

Conditions: Health Adult Subjects
Interventions: Omaveloxolone, Moxifloxacin; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 55 Years
Enrollment: 30 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2023
U.S. locations: 1
States / cities: Tempe, Arizona

Conditions: Friedreich Ataxia
Interventions: Omaveloxolone; Drug
Lead sponsor: Biogen; Industry
Eligibility: 16 Years and older · Female only
Enrollment: 10 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2035
U.S. locations: 1
States / cities: Morrisville, North Carolina

Conditions: Healthy Volunteer
Interventions: Omaveloxolone; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 55 Years
Enrollment: 52 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2025
U.S. locations: 1
States / cities: Austin, Texas

Conditions: Healthy Volunteer
Interventions: Omaveloxolone; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 45 Years · Female only
Enrollment: 12 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2024 – 2025
U.S. locations: 1
States / cities: Madison, Wisconsin

Conditions: Healthy Adult Subjects
Interventions: Omaveloxolone, Efavirenz; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 55 Years
Enrollment: 20 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2023
U.S. locations: 1
States / cities: Tempe, Arizona

Conditions: Healthy Volunteer
Interventions: Omaveloxolone, Omeprazole; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 55 Years
Enrollment: 22 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2025
U.S. locations: 1
States / cities: Austin, Texas

Conditions: Hepatic Impairment
Interventions: Omaveloxolone 50 mg capsules; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 70 Years
Enrollment: 48 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2019 – 2020
U.S. locations: 3
States / cities: Tustin, California • Miami, Florida • Orlando, Florida

Conditions: Healthy Male Subjects
Interventions: [14C]-Omaveloxolone; Drug
Lead sponsor: Biogen; Industry
Eligibility: 18 Years to 55 Years · Male only
Enrollment: 8 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2019
U.S. locations: 1
States / cities: Madison, Wisconsin

Conditions: Friedreich Ataxia
Interventions: Omaveloxolone; Drug
Lead sponsor: Biogen; Industry
Eligibility: 2 Years to 15 Years
Enrollment: 33 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2030
U.S. locations: 1
States / cities: Philadelphia, Pennsylvania

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RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE

RTA 408 Capsules in Patients With Melanoma - REVEAL

RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR

A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia

RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD

A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

RTA 408 Lotion in Healthy Volunteers

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

RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery

RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER

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

A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone

A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55

A TQTc Study for Omaveloxolone

A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies

A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55

A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk

An Open-label DDI Study of Omaveloxolone in Healthy Subjects

A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55

A Pharmacokinetic Study of Omaveloxolone in Subjects With Hepatic Impairment and Normal Hepatic Function

A Human AME Study for Omaveloxolone

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