Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Multiple Sclerosis
In brief
The primary objective of Part 1 of this study is to evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks. The primary objective of Part 2 of this study is to evaluate the long-term safety profile of BIIB033 as an add-on therapy in participants with MS. The secondary objective of Part 1 is to evaluate the effects of BIIB033 versus placebo on additional measures of disability improvement. The secondary objective of Part 2 is to investigate long-term efficacy (disability improvement) and additional safety measures of BIIB033 as an add-on therapy in participants with MS.
Key facts
- Study ID
- NCT03222973
- Run by
- Biogen
- People needed
- 263
- Starts
- 2017-11-15
- Expected to finish
- 2021-02-12
- Last updated by the study team
- 2022-04-28
Who can join
Age: 18 and older, up to 58. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Gilbert, Arizona, United States
- Research Site — Berkeley, California, United States
- Research Site — Long Beach, California, United States
- Research Site — Newport Beach, California, United States
- Research Site — Orange, California, United States
- Research Site — Centennial, Colorado, United States
- Research Site — Fort Collins, Colorado, United States
- Research Site — Stamford, Connecticut, United States
- Research Site — Washington D.C., District of Columbia, United States
- Research Site — Sunrise, Florida, United States
- Research Site — Tampa, Florida, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Chicago, Illinois, United States
- Research Site — Chicago, Illinois, United States
- Research Site — Overland Park, Kansas, United States
- Research Site — Lexington, Kentucky, United States
- Research Site — Baltimore, Maryland, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Lexington, Massachusetts, United States
- Research Site — Wellesley, Massachusetts, United States
- Research Site — Farmington Hills, Michigan, United States
- Research Site — Minneapolis, Minnesota, United States
- Research Site — St Louis, Missouri, United States
- Research Site — Cullman, Alabama, United States
Full record on ClinicalTrials.gov
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