A Study of TAK-079 in People With Generalized Myasthenia Gravis

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04159805
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 2
Start date	January 14, 2020
Completion date	July 12, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05039190` - Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients	Phase 3
Recruiting	`NCT04561557` - Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System	Early Phase 1
Completed	`NCT01727193` - The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy	Phase 3
Completed	`NCT00285350` - Mycophenolate Mofetil in Myasthenia Gravis	Phase 3
Recruiting	`NCT05890833` - The Risk of Falls Index for Patients With Neuromuscular Disorders
Completed	`NCT05694234` - Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study
Recruiting	`NCT05635266` - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Not yet recruiting	`NCT05095103` - Immune Profiles in Myasthenia Gravis
Not yet recruiting	`NCT04965987` - Oxaloacetate in Myasthenia Gravis	Phase 1
Completed	`NCT02774239` - A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG)	Phase 3
Terminated	`NCT02102594` - Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)	Phase 2
Completed	`NCT02066519` - Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis	N/A
Completed	`NCT02118805` - Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders
Terminated	`NCT01828294` - Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis	Phase 1
Terminated	`NCT00727194` - Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis	Phase 2
Completed	`NCT04590716` - Help Build an A.I. Model to Predict Myasthenia Gravis Symptom Patterns and Flares
Recruiting	`NCT04837625` - Study of Myasthenic Crisis in China
Not yet recruiting	`NCT01469858` - Perception and Multisensory Integration in Neurological Patients Using fMRI	N/A
Completed	`NCT05408702` - Exercise in Autoimmune Myasthenia Gravis and Myasthenic Syndromes
Completed	`NCT03205306` - Myasthenia Gravis and Psyche

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.