A Study of TAK-079 in People With Generalized Myasthenia Gravis
Public ClinicalTrials.gov record NCT04159805. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04159805
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 14, 2020 (Actual)
- Primary completion
- Jul 12, 2022 (Actual)
- Completion
- Jul 12, 2022 (Actual)
- Last update posted
- Jun 2, 2023
2020 – 2022
United States locations
- U.S. sites
- 27
- U.S. states
- 15
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Medical Center | Tucson | Arizona | 85713 | — |
| Stanford Neuroscience Health Center | Palo Alto | California | 94304 | — |
| University of California Davis Medical Center | Sacramento | California | 95816 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| George Washington University | Washington D.C. | District of Columbia | 20037 | — |
| SFM Clinical Research, LLC | Boca Raton | Florida | 33487 | — |
| Neurology Associates PA | Maitland | Florida | 32751 | — |
| Medsol Clinical Research Center Inc | Port Charlotte | Florida | 33952 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Consultants In Neurology | Northbrook | Illinois | 60062 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Michigan State University | East Lansing | Michigan | 48824 | — |
| Neurology and Sleep Disorders Clinic | Columbia | Missouri | 65212 | — |
| Hospital For Special Surgery | New York | New York | 10021 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Carolinas HealthCare System Neurosciences Institute-Neurology | Charlotte | North Carolina | 28207 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Austin Neuromuscular Center | Austin | Texas | 78756 | — |
| The University of Texas South Western Medical Center | Dallas | Texas | 75390 | — |
| Central Texas Neurology Consultants PA | Round Rock | Texas | 78681 | — |
| Center for Neurological Disorders | Milwaukee | Wisconsin | 53215 | — |
| The Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04159805, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 2, 2023 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04159805 live on ClinicalTrials.gov.