Trial Outcomes & Findings for A Study of TAK-079 in People With Generalized Myasthenia Gravis (NCT NCT04159805)

NCT ID: NCT04159805

Last Updated: 2023-06-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: From signing the informed consent form up to end of long-term follow-up (up to Week 32)
• Results posted on: 2023-06-02

Participant Flow

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.

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.

Participant milestones

Measure	TAK-079 Placebo-matching TAK-079 placebo-matching injection, subcutaneously (SC), once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
Overall Study STARTED	12	12	12
Overall Study COMPLETED	12	10	10
Overall Study NOT COMPLETED	0	2	2

Reasons for withdrawal

Measure	TAK-079 Placebo-matching TAK-079 placebo-matching injection, subcutaneously (SC), once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
Overall Study Withdrawal by Subject	0	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	TAK-079 Placebo-matching n=12 Participants TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=12 Participants TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg n=12 Participants TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	Total n=36 Participants Total of all reporting groups
Age, Continuous	46.5 years STANDARD_DEVIATION 18.03 • n=5 Participants	45.3 years STANDARD_DEVIATION 12.47 • n=7 Participants	56.3 years STANDARD_DEVIATION 14.42 • n=5 Participants	49.4 years STANDARD_DEVIATION 15.54 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	32 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	33 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Canada	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment Poland	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment Serbia	5 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment Spain	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment United States	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Height	164.67 cm STANDARD_DEVIATION 9.435 • n=5 Participants	175.39 cm STANDARD_DEVIATION 8.911 • n=7 Participants	171.38 cm STANDARD_DEVIATION 10.910 • n=5 Participants	170.48 cm STANDARD_DEVIATION 10.511 • n=4 Participants
Weight	85.11 kg STANDARD_DEVIATION 25.607 • n=5 Participants	86.28 kg STANDARD_DEVIATION 21.132 • n=7 Participants	88.38 kg STANDARD_DEVIATION 25.672 • n=5 Participants	86.59 kg STANDARD_DEVIATION 23.568 • n=4 Participants
Body Mass Index (BMI)	31.33 kg/m^2 STANDARD_DEVIATION 8.867 • n=5 Participants	27.74 kg/m^2 STANDARD_DEVIATION 4.852 • n=7 Participants	30.22 kg/m^2 STANDARD_DEVIATION 9.315 • n=5 Participants	29.76 kg/m^2 STANDARD_DEVIATION 7.855 • n=4 Participants
Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score at Baseline	7.9 score on a scale STANDARD_DEVIATION 1.78 • n=5 Participants	9.3 score on a scale STANDARD_DEVIATION 2.49 • n=7 Participants	8.4 score on a scale STANDARD_DEVIATION 2.23 • n=5 Participants	8.5 score on a scale STANDARD_DEVIATION 2.20 • n=4 Participants
Quantitative Myasthenia Gravis (QMG) Scale Score at Baseline	11.4 score on a scale STANDARD_DEVIATION 5.21 • n=5 Participants	12.9 score on a scale STANDARD_DEVIATION 6.47 • n=7 Participants	12.8 score on a scale STANDARD_DEVIATION 4.26 • n=5 Participants	12.4 score on a scale STANDARD_DEVIATION 5.28 • n=4 Participants
Myasthenia Gravis Composite (MGC) Scale Score at Baseline	14.7 score on a scale STANDARD_DEVIATION 5.80 • n=5 Participants	16.8 score on a scale STANDARD_DEVIATION 6.58 • n=7 Participants	15.3 score on a scale STANDARD_DEVIATION 6.00 • n=5 Participants	15.6 score on a scale STANDARD_DEVIATION 6.03 • n=4 Participants
Revised 15-item Myasthenia Gravis Quality of Life Scale (MG-QoL15r) Scale Score at Baseline	11.5 score on a scale STANDARD_DEVIATION 4.15 • n=5 Participants	17.1 score on a scale STANDARD_DEVIATION 6.76 • n=7 Participants	13.9 score on a scale STANDARD_DEVIATION 4.72 • n=5 Participants	14.2 score on a scale STANDARD_DEVIATION 5.67 • n=4 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TAK-079 Placebo-matching n=12 Participants TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=12 Participants TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg n=12 Participants TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
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	75.0 percentage of participants	91.7 percentage of participants
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	8.3 percentage of participants	8.3 percentage of participants
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	8.3 percentage of participants	8.3 percentage of participants
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	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TAK-079 Placebo-matching n=12 Participants TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=12 Participants TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg n=12 Participants TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
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	-2.5 score on a scale Standard Deviation 2.47	-1.8 score on a scale Standard Deviation 1.66
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	-4.2 score on a scale Standard Deviation 2.64	-2.3 score on a scale Standard Deviation 2.15
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 2.80	-4.3 score on a scale Standard Deviation 3.10	-2.0 score on a scale Standard Deviation 3.16
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	-5.0 score on a scale Standard Deviation 2.41	-2.0 score on a scale Standard Deviation 2.79
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	-4.2 score on a scale Standard Deviation 2.56	-2.5 score on a scale Standard Deviation 2.68
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	-4.8 score on a scale Standard Deviation 2.20	-2.0 score on a scale Standard Deviation 3.30
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	-4.3 score on a scale Standard Deviation 2.79	-3.1 score on a scale Standard Deviation 3.48
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 3.60	-2.9 score on a scale Standard Deviation 3.11
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	-3.0 score on a scale Standard Deviation 3.57
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	-3.1 score on a scale Standard Deviation 3.37
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	-2.8 score on a scale Standard Deviation 3.99

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TAK-079 Placebo-matching n=12 Participants TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=12 Participants TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg n=12 Participants TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
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	-2.0 score on a scale Standard Deviation 2.70	-0.2 score on a scale Standard Deviation 2.89
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	-2.5 score on a scale Standard Deviation 3.24	-1.3 score on a scale Standard Deviation 3.10
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score Change From Baseline at Week 8	-1.0 score on a scale Standard Deviation 2.30	-3.4 score on a scale Standard Deviation 3.35	-0.9 score on a scale Standard Deviation 3.27
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	-3.2 score on a scale Standard Deviation 3.09	-0.7 score on a scale Standard Deviation 4.03
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	-3.9 score on a scale Standard Deviation 2.55	-0.8 score on a scale Standard Deviation 3.51
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	-3.5 score on a scale Standard Deviation 2.51	0.6 score on a scale Standard Deviation 4.65
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	-3.3 score on a scale Standard Deviation 3.43	-0.3 score on a scale Standard Deviation 4.81
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	-0.5 score on a scale Standard Deviation 4.27
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	-0.6 score on a scale Standard Deviation 3.78
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score Change From Baseline at Week 28	—	-1.7 score on a scale Standard Deviation 3.80	-0.8 score on a scale Standard Deviation 4.52
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	-0.1 score on a scale Standard Deviation 4.79

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TAK-079 Placebo-matching n=12 Participants TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=12 Participants TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg n=12 Participants TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
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	-4.9 score on a scale Standard Deviation 3.82	-1.1 score on a scale Standard Deviation 5.92
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	-6.1 score on a scale Standard Deviation 5.24	-4.9 score on a scale Standard Deviation 4.74
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	-7.4 score on a scale Standard Deviation 4.63	-2.4 score on a scale Standard Deviation 6.10
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	-7.6 score on a scale Standard Deviation 5.07	-2.6 score on a scale Standard Deviation 6.55
Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score Change From Baseline at Week 12	-7.3 score on a scale Standard Deviation 5.00	-8.5 score on a scale Standard Deviation 3.11	-5.1 score on a scale Standard Deviation 5.11
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	-9.7 score on a scale Standard Deviation 3.83	-0.9 score on a scale Standard Deviation 8.25
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	-9.2 score on a scale Standard Deviation 5.18	-2.9 score on a scale Standard Deviation 6.45
Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score Change From Baseline at Week 20	—	-7.3 score on a scale Standard Deviation 5.20	-2.6 score on a scale Standard Deviation 7.21
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	-3.3 score on a scale Standard Deviation 7.30
Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Score Change From Baseline at Week 28	—	-5.6 score on a scale Standard Deviation 6.40	-4.1 score on a scale Standard Deviation 7.59
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	-2.5 score on a scale Standard Deviation 8.07

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TAK-079 Placebo-matching n=12 Participants TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=12 Participants TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg n=12 Participants TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
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	-3.9 score on a scale Standard Deviation 4.46	-3.2 score on a scale Standard Deviation 4.43
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	-5.8 score on a scale Standard Deviation 6.00	-3.4 score on a scale Standard Deviation 3.53
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 4.00	-5.6 score on a scale Standard Deviation 6.53	-3.3 score on a scale Standard Deviation 3.74
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	-6.3 score on a scale Standard Deviation 6.07	-3.9 score on a scale Standard Deviation 3.70
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	-6.1 score on a scale Standard Deviation 7.25	-4.1 score on a scale Standard Deviation 4.40
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	-6.4 score on a scale Standard Deviation 6.98	-0.9 score on a scale Standard Deviation 5.49
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	-5.8 score on a scale Standard Deviation 6.83	-2.3 score on a scale Standard Deviation 6.43
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	-4.7 score on a scale Standard Deviation 5.48
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	-3.8 score on a scale Standard Deviation 5.31
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	-4.0 score on a scale Standard Deviation 6.16
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	-2.4 score on a scale Standard Deviation 4.78

SECONDARY outcome

Timeframe: 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.

Clinical laboratory evaluations of anti-AChR antibodies were tested to monitor disease activity. MMRM was used for the analysis.

Outcome measures

Measure	TAK-079 Placebo-matching n=11 Participants TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=10 Participants TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg n=12 Participants TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 32	—	-51.296 nmol/L Standard Deviation 67.3437	-5.485 nmol/L Standard Deviation 11.8380
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 2	6.300 nmol/L Standard Deviation 25.3514	-19.452 nmol/L Standard Deviation 50.5551	-3.450 nmol/L Standard Deviation 5.7767
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 3	-3.989 nmol/L Standard Deviation 22.9732	-14.821 nmol/L Standard Deviation 44.4776	2.509 nmol/L Standard Deviation 17.5221
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 4	0.976 nmol/L Standard Deviation 11.7759	-24.253 nmol/L Standard Deviation 51.2627	13.680 nmol/L Standard Deviation 87.1669
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 5	-8.199 nmol/L Standard Deviation 13.9571	-32.251 nmol/L Standard Deviation 58.3701	-9.831 nmol/L Standard Deviation 26.2188
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 6	-19.152 nmol/L Standard Deviation 49.2221	-27.518 nmol/L Standard Deviation 52.6672	-2.148 nmol/L Standard Deviation 23.2543
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 7	-11.235 nmol/L Standard Deviation 26.2159	-33.261 nmol/L Standard Deviation 56.3495	-9.882 nmol/L Standard Deviation 16.2972
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 8	7.731 nmol/L Standard Deviation 27.8994	-39.386 nmol/L Standard Deviation 72.3110	-5.668 nmol/L Standard Deviation 10.4493
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 10	-37.473 nmol/L Standard Deviation 120.9186	-37.083 nmol/L Standard Deviation 60.8092	-6.654 nmol/L Standard Deviation 7.8236
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 12	-0.832 nmol/L Standard Deviation 31.0318	-38.430 nmol/L Standard Deviation 64.4594	-7.827 nmol/L Standard Deviation 11.2120
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 14	12.729 nmol/L Standard Deviation 49.8823	-40.771 nmol/L Standard Deviation 74.3624	-8.058 nmol/L Standard Deviation 15.8407
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 16	3.501 nmol/L Standard Deviation 9.8729	-49.843 nmol/L Standard Deviation 77.6316	-4.909 nmol/L Standard Deviation 8.8478
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 20	—	-52.217 nmol/L Standard Deviation 83.1537	-4.378 nmol/L Standard Deviation 7.7297
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 24	—	-43.079 nmol/L Standard Deviation 77.4438	-4.802 nmol/L Standard Deviation 10.5639
Change From Baseline in Anti-acetylcholine Receptor (AChR) Antibody Levels Change From Baseline at Week 28	—	-73.786 nmol/L Standard Deviation 111.0044	-6.044 nmol/L Standard Deviation 11.3755

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TAK-079 Placebo-matching n=1 Participants TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=2 Participants TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels Change From Baseline at Week 2	0.0 titer Standard Deviation NA Standard deviation (SD) was not estimable for 1 participant.	-160.0 titer Standard Deviation 226.27	—
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels Change From Baseline at Week 3	0.0 titer Standard Deviation NA SD was not estimable for 1 participant.	-200.0 titer Standard Deviation 169.71	—
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels Change From Baseline at Week 4	0.0 titer Standard Deviation NA SD was not estimable for 1 participant.	-240.0 titer Standard Deviation 339.41	—
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels Change From Baseline at Week 5	0.0 titer Standard Deviation NA SD was not estimable for 1 participant.	-240.0 titer Standard Deviation 339.41	—
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels Change From Baseline at Week 6	0.0 titer Standard Deviation NA SD was not estimable for 1 participant.	-240.0 titer Standard Deviation 339.41	—
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels Change From Baseline at Week 7	0.0 titer Standard Deviation NA SD was not estimable for 1 participant.	-240.0 titer Standard Deviation 339.41	—
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels Change From Baseline at Week 8	0.0 titer Standard Deviation NA SD was not estimable for 1 participant.	-280.0 titer Standard Deviation 395.98	—
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels Change From Baseline at Week 10	0.0 titer Standard Deviation NA SD was not estimable for 1 participant.	-280.0 titer Standard Deviation 395.98	—
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels Change From Baseline at Week 12	0.0 titer Standard Deviation NA SD was not estimable for 1 participant.	-300.0 titer Standard Deviation 424.26	—
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels Change From Baseline at Week 14	0.0 titer Standard Deviation NA SD was not estimable for 1 participant.	-300.0 titer Standard Deviation 424.26	—
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels Change From Baseline at Week 16	0.0 titer Standard Deviation NA SD was not estimable for 1 participant.	-300.0 titer Standard Deviation 424.26	—
Change From Baseline in Anti- Muscle-specific Tyrosine Kinase (MuSK) Titer Levels Change From Baseline at Week 20	—	0.0 titer Standard Deviation NA SD was not estimable for 1 participant.	—
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	—
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	—
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	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TAK-079 Placebo-matching n=12 Participants TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=12 Participants TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg n=12 Participants TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
Percentage of Participants With 2-point Reduction in MG-ADL Total Score Week 8	83.33 percentage of participants	66.67 percentage of participants	66.67 percentage of participants
Percentage of Participants With 2-point Reduction in MG-ADL Total Score Week 10	83.33 percentage of participants	83.33 percentage of participants	50.00 percentage of participants
Percentage of Participants With 2-point Reduction in MG-ADL Total Score Week 12	75.00 percentage of participants	75.00 percentage of participants	50.00 percentage of participants
Percentage of Participants With 2-point Reduction in MG-ADL Total Score Week 14	66.67 percentage of participants	75.00 percentage of participants	50.00 percentage of participants
Percentage of Participants With 2-point Reduction in MG-ADL Total Score Week 16	66.67 percentage of participants	66.67 percentage of participants	33.33 percentage of participants
Percentage of Participants With 2-point Reduction in MG-ADL Total Score Week 20	0.0 percentage of participants	66.67 percentage of participants	58.33 percentage of participants
Percentage of Participants With 2-point Reduction in MG-ADL Total Score Week 24	0.0 percentage of participants	58.33 percentage of participants	58.33 percentage of participants
Percentage of Participants With 2-point Reduction in MG-ADL Total Score Week 28	0.0 percentage of participants	58.33 percentage of participants	58.33 percentage of participants
Percentage of Participants With 2-point Reduction in MG-ADL Total Score Week 32	0.0 percentage of participants	41.67 percentage of participants	41.67 percentage of participants
Percentage of Participants With 2-point Reduction in MG-ADL Total Score Week 4	50.00 percentage of participants	75.00 percentage of participants	58.33 percentage of participants
Percentage of Participants With 2-point Reduction in MG-ADL Total Score Week 6	91.67 percentage of participants	75.00 percentage of participants	58.33 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TAK-079 Placebo-matching n=12 Participants TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=12 Participants TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg n=12 Participants TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
Percentage of Participants With 3-point Reduction in QMG Total Score Week 4	25.00 percentage of participants	50.00 percentage of participants	16.67 percentage of participants
Percentage of Participants With 3-point Reduction in QMG Total Score Week 6	16.67 percentage of participants	41.67 percentage of participants	33.33 percentage of participants
Percentage of Participants With 3-point Reduction in QMG Total Score Week 8	33.33 percentage of participants	66.67 percentage of participants	33.33 percentage of participants
Percentage of Participants With 3-point Reduction in QMG Total Score Week 10	33.33 percentage of participants	66.67 percentage of participants	33.33 percentage of participants
Percentage of Participants With 3-point Reduction in QMG Total Score Week 12	41.67 percentage of participants	75.00 percentage of participants	25.00 percentage of participants
Percentage of Participants With 3-point Reduction in QMG Total Score Week 14	33.33 percentage of participants	66.67 percentage of participants	25.00 percentage of participants
Percentage of Participants With 3-point Reduction in QMG Total Score Week 16	33.33 percentage of participants	58.33 percentage of participants	33.33 percentage of participants
Percentage of Participants With 3-point Reduction in QMG Total Score Week 20	0.0 percentage of participants	41.67 percentage of participants	33.33 percentage of participants
Percentage of Participants With 3-point Reduction in QMG Total Score Week 24	0.0 percentage of participants	41.67 percentage of participants	33.33 percentage of participants
Percentage of Participants With 3-point Reduction in QMG Total Score Week 28	0.0 percentage of participants	41.67 percentage of participants	25.00 percentage of participants
Percentage of Participants With 3-point Reduction in QMG Total Score Week 32	0.0 percentage of participants	16.67 percentage of participants	16.67 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	TAK-079 Placebo-matching n=12 Participants TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=12 Participants TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg n=12 Participants TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
Percentage of Participants With 3-point Reduction in MGC Total Score Week 4	66.67 percentage of participants	75.00 percentage of participants	41.67 percentage of participants
Percentage of Participants With 3-point Reduction in MGC Total Score Week 6	83.33 percentage of participants	66.67 percentage of participants	58.33 percentage of participants
Percentage of Participants With 3-point Reduction in MGC Total Score Week 8	83.33 percentage of participants	83.33 percentage of participants	58.33 percentage of participants
Percentage of Participants With 3-point Reduction in MGC Total Score Week 10	83.33 percentage of participants	75.00 percentage of participants	50.00 percentage of participants
Percentage of Participants With 3-point Reduction in MGC Total Score Week 12	75.00 percentage of participants	91.67 percentage of participants	58.33 percentage of participants
Percentage of Participants With 3-point Reduction in MGC Total Score Week 14	66.67 percentage of participants	83.33 percentage of participants	50.00 percentage of participants
Percentage of Participants With 3-point Reduction in MGC Total Score Week 16	66.67 percentage of participants	75.00 percentage of participants	41.67 percentage of participants
Percentage of Participants With 3-point Reduction in MGC Total Score Week 20	0.0 percentage of participants	75.00 percentage of participants	58.33 percentage of participants
Percentage of Participants With 3-point Reduction in MGC Total Score Week 24	0.0 percentage of participants	66.67 percentage of participants	50.00 percentage of participants
Percentage of Participants With 3-point Reduction in MGC Total Score Week 28	0.0 percentage of participants	58.33 percentage of participants	50.00 percentage of participants
Percentage of Participants With 3-point Reduction in MGC Total Score Week 32	0.0 percentage of participants	41.67 percentage of participants	25.00 percentage of participants

Adverse Events

TAK-079 Placebo-matching

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

TAK-079 300 mg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

TAK-079 600 mg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	TAK-079 Placebo-matching n=12 participants at risk TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=12 participants at risk TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg n=12 participants at risk TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
Gastrointestinal disorders Enteritis	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Myasthenia gravis	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Psychiatric disorders Suicidal ideation	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.

Other adverse events

Measure	TAK-079 Placebo-matching n=12 participants at risk TAK-079 placebo-matching injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 300 mg n=12 participants at risk TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.	TAK-079 600 mg n=12 participants at risk TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks.
Infections and infestations Abdominal wall abscess	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Abscess limb	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Eye disorders Angle closure glaucoma	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Asthenia	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Cardiac disorders Atrioventricular block first degree	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Bartholin's abscess	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Investigations Blood glucose increased	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Investigations Blood immunoglobulin A decreased	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Cellulitis	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Chest discomfort	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Chills	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	25.0% 3/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Eye disorders Conjunctivitis allergic	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Psychiatric disorders Depression	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Eye disorders Diplopia	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Dysarthria	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Early satiety	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	16.7% 2/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Feeling cold	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Feeling hot	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Vascular disorders Haematoma	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Headache	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Immune system disorders Immunisation reaction	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Influenza like illness	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Injection site bruising	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Injection site haematoma	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Injection site hypertrophy	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Injection site pain	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint noise	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Limb injury	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Investigations Lymphocyte count decreased	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphopenia	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Malaise	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Myasthenia gravis	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	16.7% 2/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Eye disorders Ocular hypertension	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Odynophagia	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Parosmia	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Eye disorders Periorbital oedema	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
General disorders Pyrexia	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	16.7% 2/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	25.0% 3/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash papular	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Investigations SARS-CoV-2 test positive	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Investigations Staphylococcus test positive	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Nervous system disorders Tension headache	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytosis	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Renal and urinary disorders Urine odour abnormal	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Eye disorders Visual impairment	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Eye disorders Vitreous detachment	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	0.00% 0/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.	8.3% 1/12 • From signing the informed consent form up to end of long-term follow-up (up to Week 32) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who received at least 1 dose of study drug.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: TrialDisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER