A Study of TAK-079 in People With Generalized Myasthenia Gravis
Completed · Phase 2 · Has a placebo group
Conditions studied: Myasthenia Gravis
In brief
Myasthenia gravis is an autoimmune condition that causes muscle weakness. Autoimmune means the body makes antibodies that attack its own cells and tissues. These types of antibodies are also known as autoantibodies. People with generalized myasthenia gravis have a weakness in many muscles. TAK-079 is a medicine to help people with generalized myasthenia gravis. The main aim of this study is to check if people with generalized myasthenia gravis have side effects from 2 doses of TAK-079. Other aims are to learn if TAK-079 improves their clinical condition and lowers their autoantibody levels. At the first visit, the study doctor will check if each person can take part. For those who can take part, participants will continue with their standard medicines for this condition during the study. Each participant will have a check-up by the study doctor. Then, the participants will have 1 of 3 treatments: * A low dose of TAK-079. * A high dose of TAK-079. * A placebo. In this study, a placebo looks like TAK-079 but does not have any medicine in it. Participants will not know which treatment they received, nor will their study doctors. This is to help make sure the results are more reliable. For each treatment, participants will receive injections just under the skin, once a week for 8 weeks. The study doctors will check for side effects from the study treatments. The study doctors can stop or delay the injections in each participant if needed. Then, the study doctors will continue to check for side effects for up to 24 weeks after treatment. They will also check the clinical condition of the participants, including their autoantibody levels.
Key facts
- Study ID
- NCT04159805
- Run by
- Takeda
- People needed
- 36
- Starts
- 2020-01-14
- Expected to finish
- 2022-07-12
- Last updated by the study team
- 2023-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The University of Arizona Medical Center — Tucson, Arizona, United States
- Stanford Neuroscience Health Center — Palo Alto, California, United States
- University of California Davis Medical Center — Sacramento, California, United States
- University of California Davis Medical Center — Sacramento, California, United States
- University of Colorado Hospital — Aurora, Colorado, United States
- George Washington University — Washington D.C., District of Columbia, United States
- SFM Clinical Research, LLC — Boca Raton, Florida, United States
- Neurology Associates PA — Maitland, Florida, United States
- Medsol Clinical Research Center Inc — Port Charlotte, Florida, United States
- Augusta University — Augusta, Georgia, United States
- Consultants In Neurology — Northbrook, Illinois, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Wayne State University — Detroit, Michigan, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Michigan State University — East Lansing, Michigan, United States
- Neurology and Sleep Disorders Clinic — Columbia, Missouri, United States
- Hospital For Special Surgery — New York, New York, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Carolinas HealthCare System Neurosciences Institute-Neurology — Charlotte, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- University of Cincinnati — Cincinnati, Ohio, United States
- Ohio State University Medical Center — Columbus, Ohio, United States
- Austin Neuromuscular Center — Austin, Texas, United States
- The University of Texas South Western Medical Center — Dallas, Texas, United States
- Central Texas Neurology Consultants PA — Round Rock, Texas, United States
Full record on ClinicalTrials.gov
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