Spots Global Cancer Trial Database for A Study of TAK-079 in People With Generalized Myasthenia Gravis
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Trial Identification
Brief Title: A Study of TAK-079 in People With Generalized Myasthenia Gravis
Official Title: A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis
Study ID: NCT04159805
Conditions
Study Description
Brief Summary: 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.
Detailed Description: Myasthenia gravis (MG) is an autoimmune disorder in which autoantibodies, such as those targeting the nicotinic acetylcholine receptor (AChR) or muscle specific kinase (MuSK), interfere with neuromuscular transmission, resulting in fatigue and weakness. The drug being tested in this study is called TAK-079. TAK-079 is being tested to treat people who have generalized myasthenia gravis.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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
Center for Neurological Disorders, Milwaukee, Wisconsin, United States
The Medical College of Wisconsin, Inc., Milwaukee, Wisconsin, United States
The Governors of the University of Calgary, Calgary, Alberta, Canada
Vancouver General Hospital (VGH), Vancouver, British Columbia, Canada
Toronto General Hospital, Toronto, Ontario, Canada
Fondazione Policlinico Universitario A Gemelli, Roma, Lazio, Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
IRCCS AOU San Martino, Genova, , Italy
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta, Milano, , Italy
Azienda Ospedaliera Sant'andrea, Rome, , Italy
Neurocentrum Bydgoszcz sp. z o.o., Bydgoszcz, Kujawsko-pomorskie, Poland
Centrum Neurologii Klinicznej Sp. z o.o., Krakow, Malopolskie, Poland
Centrum Medyczne NeuroProtect, Warsaw, , Poland
Centrum Medyczne Warszawa - PRATIA - PPDS, Warszawa, , Poland
Clinical Center of Serbia - PPDS, Belgrade, , Serbia
Military Medical Academy, Belgrade, , Serbia
Clinical Center Nis, Nis, , Serbia
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Universitario Vall d'Hebron - PPDS, Barcelona, , Spain
Hospital de La Santa Creu i Sant Pau, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario La Paz - PPDS, Madrid, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Contact Details
Name: Medical Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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