Myasthenia Gravis
Conditions
Keywords
Drug therapy
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.
Interventions
DRUGTAK-079
TAK-079 subcutaneous injection
DRUGTAK-079 Placebo
TAK-079 placebo-matching subcutaneous injection
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main 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. Main
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | From signing the informed consent form up to end of long-term follow-up (up to Week 32) | 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 disability/incapacity; congenital anomaly. Severity of TEAEs was graded using National cancer institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 definitions of Grade 1 through Grade 5 wherein Grade 1=mild symptoms, Grade 2=moderate symptoms, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening consequences and Grade 5=death related to AEs. Percentages are rounded off to whole number at single decimal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Baseline up to Week 32 | Physician-reported scale to assess MG disease severity by quantifying several body functions by physical exam. Each question is graded on a 4-point scale from 0=normal to 3=severe with a total score of 0 to 39; the higher score indicates greater disease burden. Negative change indicates improvement. MMRM was used for the analysis. |
| Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Baseline up to Week 32 | An assessment scale of MG disease activity based on a combination of participant- and physician-reported items. Items are scored based on 4 potential levels of impact: normal, mild, moderate, or severe with a total score of 0 to 50; the higher score indicates worse MG disease activity. Negative change indicates improvement. MMRM was used for the analysis. |
| Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Baseline up to Week 32 | A participant-reported score that assesses the participant's perception of impairment and disability and the degree to which the participant tolerates disease manifestations. Each question is graded on a 3-point scale from 0=normal to 2=severe with a total score of 0 to 30; the higher score indicates worse MG disease activity. Negative change indicates improvement. MMRM was used for the analysis. |
| Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Baseline up to Week 32 | Clinical laboratory evaluations of anti-AChR antibodies were tested to monitor disease activity. MMRM was used for the analysis. |
| Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Baseline up to Week 32 | Participant-reported scale to assess MG symptoms to evaluate capacity to perform activities of daily living. Each question is graded on a 4-point scale from 0=normal to 3=severe with a total score of 0 to 24; the higher score indicates greater functional impairment and disability. Negative change indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for the analysis. |
| Percentage of Participants With 2-point Reduction in MG-ADL Total Score | At Weeks 4, 6, 8, 10, 12, 14, 16, 20, 24, 28 and 32 | The percentage of responders with at least a 2-point reduction in MG-ADL total score from baseline is reported. MG-ADL is a participant-reported scale to assess MG symptoms to evaluate capacity to perform activities of daily living. Each question is graded on a 4-point scale from 0=normal to 3=severe with a total score of 0 to 24; the higher score indicates greater functional impairment and disability. Percentages are rounded off to whole number at the nearest decimal. |
| Percentage of Participants With 3-point Reduction in QMG Total Score | At Weeks 4, 6, 8, 10, 12, 14, 16, 20, 24, 28 and 32 | The percentage of responders with at least a 3-point reduction in QMG total score from baseline is reported. QMG is a physician-reported scale to assess MG disease severity by quantifying several body functions by physical exam. Each question is graded on a 4-point scale from 0=normal to 3=severe with a total score of 0 to 39; the higher score indicates greater disease burden. Percentages are rounded off to whole number at the nearest decimal. |
| Percentage of Participants With 3-point Reduction in MGC Total Score | At Weeks 4, 6, 8, 10, 12, 14, 16, 20, 24, 28 and 32 | The percentage of responders with at least a 3-point reduction in MGC total score from baseline is reported. MGC is an assessment scale of MG disease activity based on a combination of participant- and physician-reported items. Items are scored based on 4 potential levels of impact: normal, mild, moderate, or severe with a total score of 0 to 50; the higher score indicates worse MG disease activity. Percentages are rounded off to whole number at the nearest decimal. |
| Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Baseline up to Week 32 | Clinical laboratory evaluations of anti-MuSK antibodies were tested to monitor disease activity. Data is reported for participants who were positive for anti-MuSK antibodies at baseline. |
Countries
Canada, Italy, Poland, Serbia, Spain, United States
Participant flow
Recruitment details
Participants took part in the study at 15 investigative sites in the United States, Spain, Poland, Serbia, and Canada from 14 January 2020 to 12 July 2022.
Pre-assignment details
Participants with a diagnosis of Myasthenia Gravis (MG) were enrolled in 1:1:1 ratio to receive TAK-079 matching placebo, TAK-079 300 mg or TAK-079 600 mg in combination with standard background therapy.
Participants by arm
| Arm | Count |
|---|---|
| TAK-079 Placebo-matching TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks. | 12 |
| TAK-079 300 mg TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks. | 12 |
| TAK-079 600 mg TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks. | 12 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | Total | TAK-079 Placebo-matching | TAK-079 300 mg | TAK-079 600 mg |
|---|---|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 15.54 | 46.5 years STANDARD_DEVIATION 18.03 | 45.3 years STANDARD_DEVIATION 12.47 | 56.3 years STANDARD_DEVIATION 14.42 |
| Body Mass Index (BMI) | 29.76 kg/m^2 STANDARD_DEVIATION 7.855 | 31.33 kg/m^2 STANDARD_DEVIATION 8.867 | 27.74 kg/m^2 STANDARD_DEVIATION 4.852 | 30.22 kg/m^2 STANDARD_DEVIATION 9.315 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 9 Participants | 12 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Height | 170.48 cm STANDARD_DEVIATION 10.511 | 164.67 cm STANDARD_DEVIATION 9.435 | 175.39 cm STANDARD_DEVIATION 8.911 | 171.38 cm STANDARD_DEVIATION 10.91 |
| Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score at Baseline | 8.5 score on a scale STANDARD_DEVIATION 2.2 | 7.9 score on a scale STANDARD_DEVIATION 1.78 | 9.3 score on a scale STANDARD_DEVIATION 2.49 | 8.4 score on a scale STANDARD_DEVIATION 2.23 |
| Myasthenia Gravis Composite (MGC) Scale Score at Baseline | 15.6 score on a scale STANDARD_DEVIATION 6.03 | 14.7 score on a scale STANDARD_DEVIATION 5.8 | 16.8 score on a scale STANDARD_DEVIATION 6.58 | 15.3 score on a scale STANDARD_DEVIATION 6 |
| Quantitative Myasthenia Gravis (QMG) Scale Score at Baseline | 12.4 score on a scale STANDARD_DEVIATION 5.28 | 11.4 score on a scale STANDARD_DEVIATION 5.21 | 12.9 score on a scale STANDARD_DEVIATION 6.47 | 12.8 score on a scale STANDARD_DEVIATION 4.26 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 10 Participants | 12 Participants | 11 Participants |
| Region of Enrollment Canada | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Poland | 5 Participants | 1 Participants | 2 Participants | 2 Participants |
| Region of Enrollment Serbia | 17 Participants | 5 Participants | 7 Participants | 5 Participants |
| Region of Enrollment Spain | 4 Participants | 3 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 8 Participants | 3 Participants | 2 Participants | 3 Participants |
| Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score at Baseline | 14.2 score on a scale STANDARD_DEVIATION 5.67 | 11.5 score on a scale STANDARD_DEVIATION 4.15 | 17.1 score on a scale STANDARD_DEVIATION 6.76 | 13.9 score on a scale STANDARD_DEVIATION 4.72 |
| Sex: Female, Male Female | 22 Participants | 9 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Male | 14 Participants | 3 Participants | 6 Participants | 5 Participants |
| Weight | 86.59 kg STANDARD_DEVIATION 23.568 | 85.11 kg STANDARD_DEVIATION 25.607 | 86.28 kg STANDARD_DEVIATION 21.132 | 88.38 kg STANDARD_DEVIATION 25.672 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 8 / 12 | 9 / 12 | 11 / 12 |
| serious Total, serious adverse events | 1 / 12 | 1 / 12 | 1 / 12 |
Outcome results
Primary
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation
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 disability/incapacity; congenital anomaly. Severity of TEAEs was graded using National cancer institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 definitions of Grade 1 through Grade 5 wherein Grade 1=mild symptoms, Grade 2=moderate symptoms, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening consequences and Grade 5=death related to AEs. Percentages are rounded off to whole number at single decimal.
Time frame: From signing the informed consent form up to end of long-term follow-up (up to Week 32)
Population: Safety Analysis Set included participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-079 Placebo-matching | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | TEAE | 66.7 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | SAE | 8.3 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | Grade 3 or Higher TEAEs | 16.7 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | AE Leading to TAK-079 Discontinuation | 0.0 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | AE Leading to TAK-079 Discontinuation | 0.0 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | TEAE | 75.0 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | Grade 3 or Higher TEAEs | 8.3 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | SAE | 8.3 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | AE Leading to TAK-079 Discontinuation | 0.0 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | SAE | 8.3 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | Grade 3 or Higher TEAEs | 8.3 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Grade 3 or Higher TEAEs, and Adverse Event (AE) Leading to TAK-079 Discontinuation | TEAE | 91.7 percentage of participants |
Secondary
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels
Clinical laboratory evaluations of anti-AChR antibodies were tested to monitor disease activity. MMRM was used for the analysis.
Time frame: Baseline up to Week 32
Population: Full Analysis Set included all randomized participants who had baseline and at least 1 post-baseline efficacy assessment. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-079 Placebo-matching | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 12 | -0.832 nmol/L | Standard Deviation 31.0318 |
| TAK-079 Placebo-matching | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 6 | -19.152 nmol/L | Standard Deviation 49.2221 |
| TAK-079 Placebo-matching | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 7 | -11.235 nmol/L | Standard Deviation 26.2159 |
| TAK-079 Placebo-matching | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 10 | -37.473 nmol/L | Standard Deviation 120.9186 |
| TAK-079 Placebo-matching | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 8 | 7.731 nmol/L | Standard Deviation 27.8994 |
| TAK-079 Placebo-matching | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 16 | 3.501 nmol/L | Standard Deviation 9.8729 |
| TAK-079 Placebo-matching | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 4 | 0.976 nmol/L | Standard Deviation 11.7759 |
| TAK-079 Placebo-matching | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 3 | -3.989 nmol/L | Standard Deviation 22.9732 |
| TAK-079 Placebo-matching | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 14 | 12.729 nmol/L | Standard Deviation 49.8823 |
| TAK-079 Placebo-matching | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 5 | -8.199 nmol/L | Standard Deviation 13.9571 |
| TAK-079 Placebo-matching | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 2 | 6.300 nmol/L | Standard Deviation 25.3514 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 5 | -32.251 nmol/L | Standard Deviation 58.3701 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 2 | -19.452 nmol/L | Standard Deviation 50.5551 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 3 | -14.821 nmol/L | Standard Deviation 44.4776 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 4 | -24.253 nmol/L | Standard Deviation 51.2627 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 6 | -27.518 nmol/L | Standard Deviation 52.6672 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 8 | -39.386 nmol/L | Standard Deviation 72.311 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 10 | -37.083 nmol/L | Standard Deviation 60.8092 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 12 | -38.430 nmol/L | Standard Deviation 64.4594 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 14 | -40.771 nmol/L | Standard Deviation 74.3624 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 16 | -49.843 nmol/L | Standard Deviation 77.6316 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 20 | -52.217 nmol/L | Standard Deviation 83.1537 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 28 | -73.786 nmol/L | Standard Deviation 111.0044 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 32 | -51.296 nmol/L | Standard Deviation 67.3437 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 7 | -33.261 nmol/L | Standard Deviation 56.3495 |
| TAK-079 300 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 24 | -43.079 nmol/L | Standard Deviation 77.4438 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 32 | -5.485 nmol/L | Standard Deviation 11.838 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 14 | -8.058 nmol/L | Standard Deviation 15.8407 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 3 | 2.509 nmol/L | Standard Deviation 17.5221 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 28 | -6.044 nmol/L | Standard Deviation 11.3755 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 16 | -4.909 nmol/L | Standard Deviation 8.8478 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 7 | -9.882 nmol/L | Standard Deviation 16.2972 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 2 | -3.450 nmol/L | Standard Deviation 5.7767 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 8 | -5.668 nmol/L | Standard Deviation 10.4493 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 6 | -2.148 nmol/L | Standard Deviation 23.2543 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 20 | -4.378 nmol/L | Standard Deviation 7.7297 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 10 | -6.654 nmol/L | Standard Deviation 7.8236 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 5 | -9.831 nmol/L | Standard Deviation 26.2188 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 24 | -4.802 nmol/L | Standard Deviation 10.5639 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 12 | -7.827 nmol/L | Standard Deviation 11.212 |
| TAK-079 600 mg | Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels | Change From Baseline at Week 4 | 13.680 nmol/L | Standard Deviation 87.1669 |
Comparison: Change From Baseline at Week 2p-value: =0.0995% CI: [-60.18, 4.38]MMRM
Comparison: Change From Baseline at Week 2p-value: =0.32895% CI: [-47.5, 15.96]MMRM
Comparison: Change From Baseline at Week 3p-value: =0.44195% CI: [-44.94, 19.63]MMRM
Comparison: Change From Baseline at Week 3p-value: =0.93195% CI: [-30.33, 33.12]MMRM
Comparison: Change From Baseline at Week 4p-value: =0.08795% CI: [-60.46, 4.11]MMRM
Comparison: Change From Baseline at Week 4p-value: =0.78395% CI: [-27.29, 36.16]MMRM
Comparison: Change From Baseline at Week 5p-value: =0.07795% CI: [-61.36, 3.21]MMRM
Comparison: Change From Baseline at Week 5p-value: =0.3395% CI: [-47.45, 16]MMRM
Comparison: Change From Baseline at Week 6p-value: =0.495% CI: [-47.19, 18.91]MMRM
Comparison: Change From Baseline at Week 6p-value: =195% CI: [-32.18, 32.19]MMRM
Comparison: Change From Baseline at Week 7p-value: =0.11795% CI: [-59.64, 6.69]MMRM
Comparison: Change From Baseline at Week 7p-value: =0.43695% CI: [-44.94, 19.44]MMRM
Comparison: Change From Baseline at Week 8p-value: =0.00595% CI: [-81.54, -14.29]MMRM
Comparison: Change From Baseline at Week 8p-value: =0.21595% CI: [-52.92, 11.95]MMRM
Comparison: Change From Baseline at Week 10p-value: =0.81595% CI: [-37.34, 29.4]MMRM
Comparison: Change From Baseline at Week 10p-value: =0.79495% CI: [-36.84, 28.22]MMRM
Comparison: Change From Baseline at Week 12p-value: =0.03395% CI: [-70.48, -3.08]MMRM
Comparison: Week 12p-value: =0.51395% CI: [-43.26, 21.67]MMRM
Comparison: Week 14p-value: =0.00295% CI: [-91.69, -20.73]MMRM
Comparison: Week 14p-value: =0.03695% CI: [-71.39, -2.48]MMRM
Comparison: Week 16p-value: =0.00195% CI: [-100.64, -25.31]MMRM
Comparison: Week 16p-value: =0.1395% CI: [-66.12, 8.51]MMRM
Secondary
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels
Clinical laboratory evaluations of anti-MuSK antibodies were tested to monitor disease activity. Data is reported for participants who were positive for anti-MuSK antibodies at baseline.
Time frame: Baseline up to Week 32
Population: Full Analysis Set included all randomized participants who had baseline and at least 1 post-baseline efficacy assessment. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-079 Placebo-matching | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 8 | 0.0 titer | — |
| TAK-079 Placebo-matching | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 10 | 0.0 titer | — |
| TAK-079 Placebo-matching | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 12 | 0.0 titer | — |
| TAK-079 Placebo-matching | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 14 | 0.0 titer | — |
| TAK-079 Placebo-matching | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 16 | 0.0 titer | — |
| TAK-079 Placebo-matching | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 2 | 0.0 titer | — |
| TAK-079 Placebo-matching | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 3 | 0.0 titer | — |
| TAK-079 Placebo-matching | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 4 | 0.0 titer | — |
| TAK-079 Placebo-matching | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 5 | 0.0 titer | — |
| TAK-079 Placebo-matching | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 6 | 0.0 titer | — |
| TAK-079 Placebo-matching | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 7 | 0.0 titer | — |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 28 | -310.0 titer | Standard Deviation 438.41 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 32 | -310.0 titer | Standard Deviation 438.41 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 5 | -240.0 titer | Standard Deviation 339.41 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 2 | -160.0 titer | Standard Deviation 226.27 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 7 | -240.0 titer | Standard Deviation 339.41 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 3 | -200.0 titer | Standard Deviation 169.71 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 10 | -280.0 titer | Standard Deviation 395.98 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 6 | -240.0 titer | Standard Deviation 339.41 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 12 | -300.0 titer | Standard Deviation 424.26 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 4 | -240.0 titer | Standard Deviation 339.41 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 14 | -300.0 titer | Standard Deviation 424.26 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 8 | -280.0 titer | Standard Deviation 395.98 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 16 | -300.0 titer | Standard Deviation 424.26 |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 20 | 0.0 titer | — |
| TAK-079 300 mg | Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels | Change From Baseline at Week 24 | -310.0 titer | Standard Deviation 438.41 |
Secondary
Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score
Participant-reported scale to assess MG symptoms to evaluate capacity to perform activities of daily living. Each question is graded on a 4-point scale from 0=normal to 3=severe with a total score of 0 to 24; the higher score indicates greater functional impairment and disability. Negative change indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for the analysis.
Time frame: Baseline up to Week 32
Population: Full Analysis Set included all randomized participants who had baseline and at least 1 post-baseline efficacy assessment. Number analyzed is the number of participants available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 16 | -4.1 score on a scale | Standard Deviation 3.21 |
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 10 | -4.0 score on a scale | Standard Deviation 3.52 |
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 6 | -4.0 score on a scale | Standard Deviation 2.73 |
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 14 | -4.0 score on a scale | Standard Deviation 4.38 |
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 12 | -4.2 score on a scale | Standard Deviation 3.19 |
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 8 | -3.8 score on a scale | Standard Deviation 2.8 |
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 4 | -2.8 score on a scale | Standard Deviation 2.67 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 8 | -4.3 score on a scale | Standard Deviation 3.1 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 24 | -4.1 score on a scale | Standard Deviation 3.62 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 28 | -3.9 score on a scale | Standard Deviation 3.96 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 32 | -2.3 score on a scale | Standard Deviation 4.61 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 10 | -5.0 score on a scale | Standard Deviation 2.41 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 12 | -4.2 score on a scale | Standard Deviation 2.56 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 14 | -4.8 score on a scale | Standard Deviation 2.2 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 16 | -4.3 score on a scale | Standard Deviation 2.79 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 20 | -3.9 score on a scale | Standard Deviation 3.6 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 4 | -2.5 score on a scale | Standard Deviation 2.47 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 6 | -4.2 score on a scale | Standard Deviation 2.64 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 20 | -2.9 score on a scale | Standard Deviation 3.11 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 16 | -3.1 score on a scale | Standard Deviation 3.48 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 6 | -2.3 score on a scale | Standard Deviation 2.15 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 32 | -2.8 score on a scale | Standard Deviation 3.99 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 24 | -3.0 score on a scale | Standard Deviation 3.57 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 4 | -1.8 score on a scale | Standard Deviation 1.66 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 12 | -2.5 score on a scale | Standard Deviation 2.68 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 10 | -2.0 score on a scale | Standard Deviation 2.79 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 28 | -3.1 score on a scale | Standard Deviation 3.37 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 14 | -2.0 score on a scale | Standard Deviation 3.3 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score | Change From Baseline at Week 8 | -2.0 score on a scale | Standard Deviation 3.16 |
Comparison: Change From Baseline at Week 4p-value: =0.77295% CI: [-1.72, 2.3]MMRM
Comparison: Change From Baseline at Week 4p-value: =0.29995% CI: [-0.94, 2.97]MMRM
Comparison: Change From Baseline at Week 6p-value: =0.92495% CI: [-2.34, 2.13]MMRM
Comparison: Change From Baseline at Week 6p-value: =0.09195% CI: [-0.32, 4.04]MMRM
Comparison: Change From Baseline at Week 8p-value: =0.88795% CI: [-2.82, 2.45]MMRM
Comparison: Change From Baseline at Week 8p-value: =0.16295% CI: [-0.76, 4.36]MMRM
Comparison: Change From Baseline at Week 10p-value: =0.78495% CI: [-3.01, 2.29]MMRM
Comparison: Change From Baseline at Week 10p-value: =0.16695% CI: [-0.79, 4.37]MMRM
Comparison: Change From Baseline at Week 12p-value: =0.72495% CI: [-1.98, 2.82]MMRM
Comparison: Change From Baseline at Week 12p-value: =0.12495% CI: [-0.52, 4.14]MMRM
Comparison: Change From Baseline at Week 14p-value: =0.85695% CI: [-2.91, 3.48]MMRM
Comparison: Change From Baseline at Week 14p-value: =0.29295% CI: [-1.48, 4.76]MMRM
Comparison: Change From Baseline at Week 16p-value: =0.94495% CI: [-3.14, 3.37]MMRM
Comparison: Change From Baseline at Week 16p-value: =0.58995% CI: [-2.33, 4.02]MMRM
Secondary
Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score
An assessment scale of MG disease activity based on a combination of participant- and physician-reported items. Items are scored based on 4 potential levels of impact: normal, mild, moderate, or severe with a total score of 0 to 50; the higher score indicates worse MG disease activity. Negative change indicates improvement. MMRM was used for the analysis.
Time frame: Baseline up to Week 32
Population: Full Analysis Set included all randomized participants who had baseline and at least 1 post-baseline efficacy assessment. Number analyzed is the number of participants available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 14 | -6.1 score on a scale | Standard Deviation 6.52 |
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 8 | -5.5 score on a scale | Standard Deviation 4.03 |
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 12 | -7.3 score on a scale | Standard Deviation 5 |
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 6 | -7.3 score on a scale | Standard Deviation 4.29 |
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 4 | -4.2 score on a scale | Standard Deviation 3.69 |
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 16 | -6.6 score on a scale | Standard Deviation 4.95 |
| TAK-079 Placebo-matching | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 10 | -7.8 score on a scale | Standard Deviation 5.86 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 20 | -7.3 score on a scale | Standard Deviation 5.2 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 16 | -9.2 score on a scale | Standard Deviation 5.18 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 24 | -7.1 score on a scale | Standard Deviation 5.78 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 28 | -5.6 score on a scale | Standard Deviation 6.4 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 32 | -3.4 score on a scale | Standard Deviation 8.13 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 4 | -4.9 score on a scale | Standard Deviation 3.82 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 6 | -6.1 score on a scale | Standard Deviation 5.24 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 8 | -7.4 score on a scale | Standard Deviation 4.63 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 10 | -7.6 score on a scale | Standard Deviation 5.07 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 12 | -8.5 score on a scale | Standard Deviation 3.11 |
| TAK-079 300 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 14 | -9.7 score on a scale | Standard Deviation 3.83 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 12 | -5.1 score on a scale | Standard Deviation 5.11 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 8 | -2.4 score on a scale | Standard Deviation 6.1 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 24 | -3.3 score on a scale | Standard Deviation 7.3 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 16 | -2.9 score on a scale | Standard Deviation 6.45 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 10 | -2.6 score on a scale | Standard Deviation 6.55 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 20 | -2.6 score on a scale | Standard Deviation 7.21 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 4 | -1.1 score on a scale | Standard Deviation 5.92 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 32 | -2.5 score on a scale | Standard Deviation 8.07 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 14 | -0.9 score on a scale | Standard Deviation 8.25 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 6 | -4.9 score on a scale | Standard Deviation 4.74 |
| TAK-079 600 mg | Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score | Change From Baseline at Week 28 | -4.1 score on a scale | Standard Deviation 7.59 |
Comparison: Change From Baseline at Week 4p-value: =0.85595% CI: [-4.14, 3.45]MMRM
Comparison: Change From Baseline at Week 4p-value: =0.09395% CI: [-0.56, 6.95]MMRM
Comparison: Change From Baseline at Week 6p-value: =0.4195% CI: [-2.61, 6.2]MMRM
Comparison: Change From Baseline at Week 6p-value: =0.15495% CI: [-1.25, 7.5]MMRM
Comparison: Change From Baseline at Week 8p-value: =0.66295% CI: [-5.29, 3.41]MMRM
Comparison: Change From Baseline at Week 8p-value: =0.1395% CI: [-1.02, 7.54]MMRM
Comparison: Change From Baseline at Week 10p-value: =0.58695% CI: [-3.44, 5.98]MMRM
Comparison: Change From Baseline at Week 10p-value: =0.03995% CI: [0.26, 9.6]MMRM
Comparison: Change From Baseline at Week 12p-value: =0.90995% CI: [-4.03, 3.6]MMRM
Comparison: Change From Baseline at Week 12p-value: =0.15895% CI: [-1.09, 6.4]MMRM
Comparison: Change From Baseline at Week 14p-value: =0.76495% CI: [-6.8, 5.05]MMRM
Comparison: Change From Baseline at Week 14p-value: =0.0895% CI: [-0.67, 11.06]MMRM
Comparison: Change From Baseline at Week 16p-value: =0.67795% CI: [-5.98, 3.95]MMRM
Comparison: Change From Baseline at Week 16p-value: =0.05595% CI: [-0.1, 9.73]MMRM
Secondary
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score
Physician-reported scale to assess MG disease severity by quantifying several body functions by physical exam. Each question is graded on a 4-point scale from 0=normal to 3=severe with a total score of 0 to 39; the higher score indicates greater disease burden. Negative change indicates improvement. MMRM was used for the analysis.
Time frame: Baseline up to Week 32
Population: Full Analysis Set included all randomized participants who had baseline and at least 1 post-baseline efficacy assessment. Number analyzed is the number of participants available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-079 Placebo-matching | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 16 | -1.2 score on a scale | Standard Deviation 3.22 |
| TAK-079 Placebo-matching | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 6 | -0.9 score on a scale | Standard Deviation 1.76 |
| TAK-079 Placebo-matching | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 10 | -1.4 score on a scale | Standard Deviation 2.87 |
| TAK-079 Placebo-matching | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 4 | -1.0 score on a scale | Standard Deviation 2.34 |
| TAK-079 Placebo-matching | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 12 | -2.8 score on a scale | Standard Deviation 2.68 |
| TAK-079 Placebo-matching | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 14 | -1.9 score on a scale | Standard Deviation 3.11 |
| TAK-079 Placebo-matching | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 8 | -1.0 score on a scale | Standard Deviation 2.3 |
| TAK-079 300 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 28 | -1.7 score on a scale | Standard Deviation 3.8 |
| TAK-079 300 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 10 | -3.2 score on a scale | Standard Deviation 3.09 |
| TAK-079 300 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 32 | -0.7 score on a scale | Standard Deviation 4.27 |
| TAK-079 300 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 4 | -2.0 score on a scale | Standard Deviation 2.7 |
| TAK-079 300 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 6 | -2.5 score on a scale | Standard Deviation 3.24 |
| TAK-079 300 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 16 | -3.3 score on a scale | Standard Deviation 3.43 |
| TAK-079 300 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 8 | -3.4 score on a scale | Standard Deviation 3.35 |
| TAK-079 300 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 20 | -1.9 score on a scale | Standard Deviation 3.56 |
| TAK-079 300 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 14 | -3.5 score on a scale | Standard Deviation 2.51 |
| TAK-079 300 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 24 | -2.2 score on a scale | Standard Deviation 4.47 |
| TAK-079 300 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 12 | -3.9 score on a scale | Standard Deviation 2.55 |
| TAK-079 600 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 32 | -0.1 score on a scale | Standard Deviation 4.79 |
| TAK-079 600 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 4 | -0.2 score on a scale | Standard Deviation 2.89 |
| TAK-079 600 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 6 | -1.3 score on a scale | Standard Deviation 3.1 |
| TAK-079 600 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 8 | -0.9 score on a scale | Standard Deviation 3.27 |
| TAK-079 600 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 10 | -0.7 score on a scale | Standard Deviation 4.03 |
| TAK-079 600 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 12 | -0.8 score on a scale | Standard Deviation 3.51 |
| TAK-079 600 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 14 | 0.6 score on a scale | Standard Deviation 4.65 |
| TAK-079 600 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 16 | -0.3 score on a scale | Standard Deviation 4.81 |
| TAK-079 600 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 20 | -0.5 score on a scale | Standard Deviation 4.27 |
| TAK-079 600 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 24 | -0.6 score on a scale | Standard Deviation 3.78 |
| TAK-079 600 mg | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score | Change From Baseline at Week 28 | -0.8 score on a scale | Standard Deviation 4.52 |
Comparison: Change From Baseline at Week 4p-value: =0.40695% CI: [-3.17, 1.31]MMRM
Comparison: Change From Baseline at Week 4p-value: =0.41895% CI: [-1.34, 3.14]MMRM
Comparison: Change From Baseline at Week 6p-value: =0.46395% CI: [-3.53, 1.65]MMRM
Comparison: Change From Baseline at Week 6p-value: =0.93695% CI: [-2.7, 2.49]MMRM
Comparison: Change From Baseline at Week 8p-value: =0.1795% CI: [-4.41, 0.82]MMRM
Comparison: Change From Baseline at Week 8p-value: =0.68795% CI: [-2.1, 3.13]MMRM
Comparison: Change From Baseline at Week 10p-value: =0.37495% CI: [-4.05, 1.57]MMRM
Comparison: Change From Baseline at Week 10p-value: =0.47895% CI: [-1.82, 3.8]MMRM
Comparison: Change From Baseline at Week 12p-value: =0.6995% CI: [-3.12, 2.09]MMRM
Comparison: Change From Baseline at Week 12p-value: =0.10695% CI: [-0.48, 4.71]MMRM
Comparison: Change From Baseline at Week 14p-value: =0.54795% CI: [-3.89, 2.12]MMRM
Comparison: Change From Baseline at Week 14p-value: =0.14495% CI: [-0.81, 5.18]MMRM
Comparison: Change From Baseline at Week 16p-value: =0.43195% CI: [-4.91, 2.17]MMRM
Comparison: Change From Baseline at Week 16p-value: =0.48895% CI: [-2.34, 4.74]MMRM
Secondary
Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score
A participant-reported score that assesses the participant's perception of impairment and disability and the degree to which the participant tolerates disease manifestations. Each question is graded on a 3-point scale from 0=normal to 2=severe with a total score of 0 to 30; the higher score indicates worse MG disease activity. Negative change indicates improvement. MMRM was used for the analysis.
Time frame: Baseline up to Week 32
Population: Full Analysis Set included all randomized participants who had baseline and at least 1 post-baseline efficacy assessment. Number analyzed is the number of participants available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-079 Placebo-matching | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 4 | -3.1 score on a scale | Standard Deviation 3.85 |
| TAK-079 Placebo-matching | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 10 | -2.5 score on a scale | Standard Deviation 6.12 |
| TAK-079 Placebo-matching | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 6 | -4.3 score on a scale | Standard Deviation 4.11 |
| TAK-079 Placebo-matching | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 12 | -2.5 score on a scale | Standard Deviation 5.32 |
| TAK-079 Placebo-matching | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 16 | -3.8 score on a scale | Standard Deviation 4.44 |
| TAK-079 Placebo-matching | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 8 | -3.2 score on a scale | Standard Deviation 4 |
| TAK-079 Placebo-matching | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 14 | -2.0 score on a scale | Standard Deviation 7.06 |
| TAK-079 300 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 14 | -6.4 score on a scale | Standard Deviation 6.98 |
| TAK-079 300 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 4 | -3.9 score on a scale | Standard Deviation 4.46 |
| TAK-079 300 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 8 | -5.6 score on a scale | Standard Deviation 6.53 |
| TAK-079 300 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 10 | -6.3 score on a scale | Standard Deviation 6.07 |
| TAK-079 300 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 12 | -6.1 score on a scale | Standard Deviation 7.25 |
| TAK-079 300 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 16 | -5.8 score on a scale | Standard Deviation 6.83 |
| TAK-079 300 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 20 | -3.3 score on a scale | Standard Deviation 7.01 |
| TAK-079 300 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 24 | -7.1 score on a scale | Standard Deviation 7.95 |
| TAK-079 300 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 28 | -4.8 score on a scale | Standard Deviation 10.36 |
| TAK-079 300 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 32 | -6.2 score on a scale | Standard Deviation 7.31 |
| TAK-079 300 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 6 | -5.8 score on a scale | Standard Deviation 6 |
| TAK-079 600 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 16 | -2.3 score on a scale | Standard Deviation 6.43 |
| TAK-079 600 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 4 | -3.2 score on a scale | Standard Deviation 4.43 |
| TAK-079 600 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 20 | -4.7 score on a scale | Standard Deviation 5.48 |
| TAK-079 600 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 32 | -2.4 score on a scale | Standard Deviation 4.78 |
| TAK-079 600 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 10 | -3.9 score on a scale | Standard Deviation 3.7 |
| TAK-079 600 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 24 | -3.8 score on a scale | Standard Deviation 5.31 |
| TAK-079 600 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 12 | -4.1 score on a scale | Standard Deviation 4.4 |
| TAK-079 600 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 8 | -3.3 score on a scale | Standard Deviation 3.74 |
| TAK-079 600 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 14 | -0.9 score on a scale | Standard Deviation 5.49 |
| TAK-079 600 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 6 | -3.4 score on a scale | Standard Deviation 3.53 |
| TAK-079 600 mg | Change From Baseline in Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score | Change From Baseline at Week 28 | -4.0 score on a scale | Standard Deviation 6.16 |
Comparison: Change From Baseline at Week 4p-value: =0.7895% CI: [-3.23, 4.27]MMRM
Comparison: Change From Baseline at Week 4p-value: =0.77195% CI: [-2.99, 3.99]MMRM
Comparison: Change From Baseline at Week 6p-value: =0.98495% CI: [-4.22, 4.14]MMRM
Comparison: Change From Baseline at Week 6p-value: =0.21395% CI: [-1.47, 6.35]MMRM
Comparison: Change From Baseline at Week 8p-value: =0.37195% CI: [-6.4, 2.45]MMRM
Comparison: Change From Baseline at Week 8p-value: =0.95695% CI: [-4.01, 4.23]MMRM
Comparison: Change From Baseline at Week 10p-value: =0.64195% CI: [-5.65, 3.53]MMRM
Comparison: Change From Baseline at Week 10p-value: =0.87695% CI: [-4.61, 3.95]MMRM
Comparison: Change From Baseline at Week 12p-value: =0.45895% CI: [-6.91, 3.18]MMRM
Comparison: Change From Baseline at Week 12p-value: =0.76995% CI: [-5.37, 4]MMRM
Comparison: Change From Baseline at Week 14p-value: =0.69995% CI: [-7.07, 4.8]MMRM
Comparison: Change From Baseline at Week 14p-value: =0.68795% CI: [-4.41, 6.62]MMRM
Comparison: Change From Baseline at Week 16p-value: =0.94495% CI: [-5.55, 5.95]MMRM
Comparison: Change From Baseline at Week 16p-value: =0.35195% CI: [-2.87, 7.83]MMRM
Secondary
Percentage of Participants With 2-point Reduction in MG-ADL Total Score
The percentage of responders with at least a 2-point reduction in MG-ADL total score from baseline is reported. MG-ADL is a participant-reported scale to assess MG symptoms to evaluate capacity to perform activities of daily living. Each question is graded on a 4-point scale from 0=normal to 3=severe with a total score of 0 to 24; the higher score indicates greater functional impairment and disability. Percentages are rounded off to whole number at the nearest decimal.
Time frame: At Weeks 4, 6, 8, 10, 12, 14, 16, 20, 24, 28 and 32
Population: Full Analysis Set included all randomized participants who had baseline and at least 1 post-baseline efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-079 Placebo-matching | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 24 | 0.0 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 6 | 91.67 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 8 | 83.33 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 10 | 83.33 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 12 | 75.00 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 14 | 66.67 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 16 | 66.67 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 20 | 0.0 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 28 | 0.0 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 32 | 0.0 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 4 | 50.00 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 24 | 58.33 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 4 | 75.00 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 16 | 66.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 6 | 75.00 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 14 | 75.00 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 12 | 75.00 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 8 | 66.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 20 | 66.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 28 | 58.33 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 10 | 83.33 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 32 | 41.67 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 10 | 50.00 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 12 | 50.00 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 14 | 50.00 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 16 | 33.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 32 | 41.67 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 20 | 58.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 24 | 58.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 6 | 58.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 4 | 58.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 8 | 66.67 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 2-point Reduction in MG-ADL Total Score | Week 28 | 58.33 percentage of participants |
Secondary
Percentage of Participants With 3-point Reduction in MGC Total Score
The percentage of responders with at least a 3-point reduction in MGC total score from baseline is reported. MGC is an assessment scale of MG disease activity based on a combination of participant- and physician-reported items. Items are scored based on 4 potential levels of impact: normal, mild, moderate, or severe with a total score of 0 to 50; the higher score indicates worse MG disease activity. Percentages are rounded off to whole number at the nearest decimal.
Time frame: At Weeks 4, 6, 8, 10, 12, 14, 16, 20, 24, 28 and 32
Population: Full Analysis Set included all randomized participants who had baseline and at least 1 post-baseline efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 24 | 0.0 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 6 | 83.33 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 8 | 83.33 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 10 | 83.33 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 12 | 75.00 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 14 | 66.67 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 16 | 66.67 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 20 | 0.0 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 28 | 0.0 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 32 | 0.0 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 4 | 66.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 24 | 66.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 4 | 75.00 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 16 | 75.00 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 6 | 66.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 14 | 83.33 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 12 | 91.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 8 | 83.33 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 20 | 75.00 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 28 | 58.33 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 10 | 75.00 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 32 | 41.67 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 10 | 50.00 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 12 | 58.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 14 | 50.00 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 16 | 41.67 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 32 | 25.00 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 20 | 58.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 24 | 50.00 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 6 | 58.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 4 | 41.67 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 8 | 58.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in MGC Total Score | Week 28 | 50.00 percentage of participants |
Secondary
Percentage of Participants With 3-point Reduction in QMG Total Score
The percentage of responders with at least a 3-point reduction in QMG total score from baseline is reported. QMG is a physician-reported scale to assess MG disease severity by quantifying several body functions by physical exam. Each question is graded on a 4-point scale from 0=normal to 3=severe with a total score of 0 to 39; the higher score indicates greater disease burden. Percentages are rounded off to whole number at the nearest decimal.
Time frame: At Weeks 4, 6, 8, 10, 12, 14, 16, 20, 24, 28 and 32
Population: Full Analysis Set included all randomized participants who had baseline and at least 1 post-baseline efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 24 | 0.0 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 6 | 16.67 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 8 | 33.33 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 10 | 33.33 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 12 | 41.67 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 14 | 33.33 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 16 | 33.33 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 20 | 0.0 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 28 | 0.0 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 32 | 0.0 percentage of participants |
| TAK-079 Placebo-matching | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 4 | 25.00 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 24 | 41.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 4 | 50.00 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 16 | 58.33 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 6 | 41.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 14 | 66.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 12 | 75.00 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 8 | 66.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 20 | 41.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 28 | 41.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 10 | 66.67 percentage of participants |
| TAK-079 300 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 32 | 16.67 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 10 | 33.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 12 | 25.00 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 14 | 25.00 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 16 | 33.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 32 | 16.67 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 20 | 33.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 24 | 33.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 6 | 33.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 4 | 16.67 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 8 | 33.33 percentage of participants |
| TAK-079 600 mg | Percentage of Participants With 3-point Reduction in QMG Total Score | Week 28 | 25.00 percentage of participants |