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

  • STATUS
    Recruiting
  • End date
    Jun 25, 2022
  • participants needed
    36
  • sponsor
    Takeda
Updated on 2 April 2021
corticosteroids
tacrolimus
mycophenolate mofetil
cyclophosphamide
cyclosporine
methotrexate
immunosuppressive agents
weakness
cholinesterase inhibitors
cholinesterase
azathioprine
serologic test
generalized myasthenia gravis
anticholinesterase agents

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.

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.

Details
Condition Myasthenia Gravis, Myasthenia Gravis generalised, Myasthenia Gravis (Chronic Weakness)
Treatment TAK-079, TAK-079 Placebo
Clinical Study IdentifierNCT04159805
SponsorTakeda
Last Modified on2 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Myasthenia Gravis (MG) supported by a positive serologic test for anti-AChR or anti-MuSK antibodies at screening
Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV at screening
Myasthenia Gravis Activities of Daily Living (MG-ADL) total score of 6 or greater at screening, with at least 4 points attributed to nonocular items
If receiving immunosuppressive drugs (ie, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus, cyclophosphamide), therapy must be ongoing for at least 6 months, with stable dosing ongoing for at least 3 months before screening. Participants receiving azathioprine must be on a stable dose for at least 6 months before screening
If receiving oral corticosteroids, therapy must be ongoing for at least 3 months, with a stable dose at least 1 month before screening. Corticosteroids, including dexamethasone, must be given as oral, daily or every-other-day therapy, as opposed to pulse therapy
If receiving cholinesterase inhibitors, therapy with a stable dose is required at least 2 weeks before screening
The doses of concomitant standard background therapy must be expected to remain stable throughout the study unless dose reduction is required due to toxicities. Allowed background therapy is defined as no more than a cholinesterase inhibitor corticosteroid 1 steroid-sparing immunosuppressive drug (limited to azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus, or cyclophosphamide). Participants must be on at least one allowed background medication

Exclusion Criteria

Presence of a thymoma (previous history of a fully encapsulated thymoma removed 12 months before screening is allowed) or history of invasive thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for 5 years before screening
History of thymectomy within 12 months before screening
MGFA class I or V
Received intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin (SCIg), or plasmapheresis/plasma exchange within 4 weeks before screening, or an expectation that any therapy besides the participants standard background therapies may be used for treatment of MG (eg, a rescue therapy) between screening and dosing
Chronic obstructive pulmonary disease (COPD) or asthma with a pre-bronchodilatory forced expiratory volume in 1 second (FEV1) <50% of predicted normal
Note: FEV1 testing is required for participants suspected of having COPD or
asthma
\. Received rituximab, belimumab, eculizumab, or any monoclonal antibody for
immunomodulation within 6 months before first dosing. Participants with prior
exposure to rituximab must have CD19 counts within the normal range at
screening
\. Known autoimmune disease other than MG that could interfere with the
course and conduct of the study
\. Received a live vaccine within 4 weeks before screening or has any live
vaccination planned during the study
\. Opportunistic infection 12 weeks before initial study dosing or currently
receiving treatment for a chronic opportunistic infection, such as
tuberculosis (TB), pneumocystis pneumonia, cytomegalovirus, herpes simplex
virus, herpes zoster, or atypical mycobacteria. A mild, localized herpes
simplex infection within 12 weeks of study dosing is allowed, as long as the
lesion has resolved without systemic therapy prior to Day 1
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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