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

NCT ID: NCT04159805

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2022-07-12

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.

Conditions

Myasthenia Gravis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TAK-079 Placebo-matching

TAK-079 placebo-matching injection, subcutaneously (SC), once weekly in combination with standard background therapy for 8 weeks.

Group Type: PLACEBO_COMPARATOR

TAK-079 Placebo

Intervention Type: DRUG

TAK-079 placebo-matching subcutaneous injection

TAK-079 300 mg

TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.

Group Type: EXPERIMENTAL

TAK-079

Intervention Type: DRUG

TAK-079 subcutaneous injection

TAK-079 600 mg

TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.

Group Type: EXPERIMENTAL

TAK-079

Intervention Type: DRUG

TAK-079 subcutaneous injection

Interventions

TAK-079

TAK-079 subcutaneous injection

Intervention Type: DRUG

TAK-079 Placebo

TAK-079 placebo-matching subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Mezagitamab

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of Myasthenia Gravis (MG) supported by a positive serologic test for anti-AChR or anti-MuSK antibodies at screening.

2. Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV at screening.

3. 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.

4. 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.

5. 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.

6. If receiving cholinesterase inhibitors, therapy with a stable dose is required at least 2 weeks before screening.

7. 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

1. 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.

2. History of thymectomy within 12 months before screening.

3. MGFA class I or V.

4. 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.

5. 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.

6. 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.

7. Known autoimmune disease other than MG that could interfere with the course and conduct of the study.

8. Received a live vaccine within 4 weeks before screening or has any live vaccination planned during the study.

9. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

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 D.C., 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

Rome, Lazio, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

IRCCS AOU San Martino

Genova, , Italy

Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

Milan, , Italy

Azienda Ospedaliera Sant'andrea

Rome, , Italy

Neurocentrum Bydgoszcz sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Neurologii Klinicznej Sp. z o.o.

Krakow, Lesser Poland Voivodeship, Poland

Centrum Medyczne NeuroProtect

Warsaw, , Poland

Centrum Medyczne Warszawa - PRATIA - PPDS

Warsaw, , Poland

Clinical Center of Serbia - PPDS

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Clinical Center Nis

Niš, , 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

Seville, , Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

Countries

United States; Canada; Italy; Poland; Serbia; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b603c4db2bf003ab4a369

To obtain more information on the study, click here/on this link

Other Identifiers

2019-003383-47

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TAK-079-1005

Identifier Type: -

Identifier Source: org_study_id