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NCT04159805 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-079 in People With Generalized Myasthenia Gravis
A Phase 2 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT04159805: Completed Phase 2 study, sponsored by Takeda.
NCT04159805 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04159805, a Phase 2 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study 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.
Primary Outcome
AE is defined as any untoward medical occurrence in clinical investigation participant administered drug; it does not necessarily have to have causal relationship with this treatment. TEAE is defined as AE with onset that occurs after receiving study drug. SAE is an adverse event resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant
Interventions
- DRUG TAK-079
- DRUG TAK-079 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-01-14 |
| Est. Completion | 2022-07-12 |
| Phase | Phase 2 |
What the finished NCT04159805 record still lists
NCT04159805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which TAK-079 is the first listed.
NCT04159805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04159805 about?
NCT04159805 is a clinical study titled "A Study of TAK-079 in People With Generalized Myasthenia Gravis". 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 ...
What is the current status of trial NCT04159805?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2020-01-14. Estimated completion is 2022-07-12.
What interventions are being tested in trial NCT04159805?
The interventions under investigation include: TAK-079 (DRUG), TAK-079 Placebo (DRUG).
Who is sponsoring clinical trial NCT04159805?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04159805's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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