A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)

• ClinicalTrials.gov Identifier: NCT03724916
• Recruitment Status: Completed
• First Posted: October 30, 2018
• Results First Posted: March 29, 2024
• Last Update Posted: March 29, 2024
• Sponsor: Millennium Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Takeda ( Millennium Pharmaceuticals, Inc. )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Other
• Conditions: Systemic Lupus Erythematosus; Lupus Erythematosus, Systemic
• Interventions: Drug: TAK-079; Drug: TAK-079 Placebo
• Enrollment: 23

Participant Flow

Recruitment Details	Participants took part in the study at 13 investigative sites in United States from 26 November 2018 to 04 November 2021.
Pre-assignment Details	Participants with moderate to severe systemic lupus erythematosus (SLE) were sequentially enrolled to receive TAK-079 45 mg, TAK-079 90 mg, TAK-079 135 mg or TAK-079-matching placebo in a 3:1 ratio in this study.

Arm/Group Title	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
Arm/Group Description	TAK-079 placebo-matching injection, subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks. Placebo data was pooled across all the dose levels.	TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
Period Title: Overall Study
Started	6	6	6	5
Safety Analysis Set [1]	5	6	6	5
Pharmacokinetic (PK) Analysis Set [2]	0	6	6	5
Pharmacodynamic (PD) Analysis Set [3]	5	6	6	5
Immunogenicity Analysis Set [4]	5	6	5	5
Completed	5	5	5	3
Not Completed	1	1	1	2
Reason Not Completed
Withdrawal by Subject	0	1	1	2
Randomized but not Treated	1	0	0	0
[1] Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug.; [2] PK analysis set included all participants who received study drug and had at least 1 measurable serum concentration.; [3] PD analysis set included all participants who received study drug and had at least 1 postdose PD measurement.; [4] Immunogenicity analysis set consisted of all participants who received study drug and had a baseline and at least 1 postbaseline immunogenicity sample assessment.

Baseline Characteristics

Arm/Group Title		Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg	Total
Arm/Group Description		TAK-079 placebo-matching injection, subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks. Placebo data was pooled across all the dose levels.	TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		5	6	6	5	22
Baseline Analysis Population Description		Safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	5 participants	6 participants	6 participants	5 participants	22 participants
		36.4 (6.58)	51.0 (22.01)	46.7 (6.53)	49.6 (13.50)	46.2 (14.17)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	5 participants	6 participants	6 participants	5 participants	22 participants
	Female	5 100.0%	6 100.0%	5 83.3%	4 80.0%	20 90.9%
	Male	0 0.0%	0 0.0%	1 16.7%	1 20.0%	2 9.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	5 participants	6 participants	6 participants	5 participants	22 participants
	Hispanic or Latino	1 20.0%	2 33.3%	0 0.0%	1 20.0%	4 18.2%
	Not Hispanic or Latino	4 80.0%	4 66.7%	6 100.0%	4 80.0%	18 81.8%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	5 participants	6 participants	6 participants	5 participants	22 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	1 20.0%	1 4.5%
	Asian	0 0.0%	0 0.0%	0 0.0%	1 20.0%	1 4.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	2 40.0%	4 66.7%	1 16.7%	2 40.0%	9 40.9%
	White	3 60.0%	2 33.3%	4 66.7%	1 20.0%	10 45.5%
	More than one race	0 0.0%	0 0.0%	1 16.7%	0 0.0%	1 4.5%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Description	An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug. An SAE is an adverse event resulting in any of the 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.
Time Frame	From the study start to end of the study (up to Week 36)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug.

Arm/Group Title	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
Arm/Group Description:	TAK-079 placebo-matching injection, subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks. Placebo data was pooled across all the dose levels.	TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
Overall Number of Participants Analyzed	5	6	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
TEAEs	3	4	6	2
SAEs	0	1	0	1

2. Primary Outcome

Title	Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)
Description	The severity of TEAEs will be graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 definitions of Grade 1 through Grade 5. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Time Frame	From the study start up to end of the study (up to Week 36)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug.

Arm/Group Title	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
Arm/Group Description:	TAK-079 placebo-matching injection, subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks. Placebo data was pooled across all the dose levels.	TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
Overall Number of Participants Analyzed	5	6	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	0	0	0	0

3. Primary Outcome

Title	Percentage of Participants With ≥ 1 Adverse Event (AE) Leading to Treatment Discontinuation
Description	An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Time Frame	From the study start up to end of the study (up to Week 36)

Outcome Measure Data

Analysis Population Description

Safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.

Arm/Group Title	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
Arm/Group Description:	TAK-079 placebo-matching injection, subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks. Placebo data was pooled across all the dose levels.	TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
Overall Number of Participants Analyzed	5	6	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	0	0	0	1

4. Secondary Outcome

Title	Cmax: Maximum Observed Plasma Concentration for TAK-079
Description	[Not Specified]
Time Frame	Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose; Day 22 pre-dose and at multiple time points (up to 108 hours) post-dose; Days 43 and 64 pre-dose and at multiple time points (up to 5 hours) post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetics analysis set consisted of all participants who received study drug and had at least 1 measurable serum concentration. Number analyzed is the number of participants available for analysis at the given time point.

Arm/Group Title		TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
Arm/Group Description:		TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
Overall Number of Participants Analyzed		6	6	5
Mean (Standard Deviation); Unit of Measure: nanograms per millilitre (ng/mL)
Day 1	Number Analyzed	6 participants	6 participants	5 participants
		57.5 (71.7)	660.0 (1050)	6130 (5170)
Day 22	Number Analyzed	6 participants	5 participants	5 participants
		95.4 (187)	1570 (2930)	6330 (9450)
Day 43	Number Analyzed	6 participants	4 participants	4 participants
		10.6 (17.5)	1440 (2550)	559 (714)
Day 64	Number Analyzed	6 participants	4 participants	4 participants
		16.4 (17.4)	568 (841)	3100 (3900)

5. Secondary Outcome

Title	AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079
Description	[Not Specified]
Time Frame	Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose; Day 22 pre-dose and at multiple time points (up to 108 hours) post-dose; Days 43 and 64 pre-dose and at multiple time points (up to 5 hours) post-dose.

Outcome Measure Data

Analysis Population Description

As pre-specified in SAP, data for AUClast was not evaluated due to sparse PK sampling.

Arm/Group Title	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
Arm/Group Description:	TAK-079 placebo-matching injection, subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks. Placebo data was pooled across all the dose levels.	TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
Overall Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

6. Secondary Outcome

Title	Number of Participants With Change From Baseline In Immune Cell Subsets
Description	Immune cell subsets included plasma cells, plasma blast (PBs), natural killer (NK) cells, B cells, T cells, monocytes, and total lymphocytes. The concentration of each plasma subset cell type is measured at baseline and post-baseline timepoints and the number of participants who had change in the concentration of each plasma subset cells from baseline were evaluated and reported in this outcome measure.
Time Frame	Baseline up to Day 85 (End of Treatment [EOT])

Outcome Measure Data

Analysis Population Description

PD analysis set included all participants who received study drug and had at least 1 postdose PD measurement. Overall number analyzed are the number of participants who had baseline and post-baseline data for change.

Arm/Group Title	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
Arm/Group Description:	TAK-079 placebo-matching injection, subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks. Placebo data was pooled across all the dose levels.	TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
Overall Number of Participants Analyzed	4	6	4	4
Measure Type: Count of Participants; Unit of Measure: Participants
Participants who had change in Plasma cell concentration	4	6	4	4
Participants who had change in Plasmablasts concentration	4	6	4	4
Participants who had change in NK cells concentration	4	6	4	4
Participants who had change in B cells concentration	4	6	4	4
Participants who had change in T cells concentration	4	6	4	4
Participants who had change in Monocytes concentration	4	6	4	4
Participants who had change in Lymphocytes concentration	4	6	4	4

7. Secondary Outcome

Title	Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy
Description	Receptor occupancy was evaluated for plasma cells, PBs, NK cells, B cells, T cells, and monocytes. The concentration of cells expressing CD38+ and those not expressing the same is correlated and used to determine receptor occupancy. The receptor occupancy of these cells was determined at baseline and post-baseline timepoints. The number of participants who had change in the receptor occupancy of these cells from baseline were evaluated and reported in this outcome measure.
Time Frame	Baseline up to Day 85 (EOT)

Outcome Measure Data

Analysis Population Description

Pharmacokinetics analysis set consisted of all participants who received study drug and had at least 1 measurable serum concentration. Overall number analyzed are the number of participants who had baseline and post-baseline data.

Arm/Group Title	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
Arm/Group Description:	TAK-079 placebo-matching injection, subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks. Placebo data was pooled across all the dose levels.	TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
Overall Number of Participants Analyzed	4	6	4	4
Measure Type: Count of Participants; Unit of Measure: Participants
Participants who had change in receptor occupancy: Plasma Cells	4	3	4	4
Participants who had change in receptor occupancy: Plasmablasts	4	5	4	4
Participants who had change in receptor occupancy: CD38+NK cells	4	5	4	4
Participants who had change in receptor occupancy: CD38+B cells	4	5	4	4
Participants who had change in receptor occupancy: CD38+T cells	4	5	4	4
Participants who had change in receptor occupancy: CD38+Monocytes	4	5	4	4

8. Secondary Outcome

Title	Change From Baseline in Cytokines Level
Description	[Not Specified]
Time Frame	Baseline up to Day 85

Outcome Measure Data

Analysis Population Description

Since no participants had potential symptoms of cytokine release syndrome (CRS) or developed a CRS while on study, the assessment for cytokines was never performed.

Arm/Group Title	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
Arm/Group Description:	TAK-079 placebo-matching injection, subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks. Placebo data was pooled across all the dose levels.	TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
Overall Number of Participants Analyzed	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

9. Secondary Outcome

Title	Number of Participants With Positive Anti-drug Antibodies
Description	[Not Specified]
Time Frame	Baseline up to Day 85 (EOT)

Outcome Measure Data

Analysis Population Description

Immunogenicity set consisted of all participants who received study drug and had a baseline and at least 1 postbaseline immunogenicity sample assessment.

Arm/Group Title	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
Arm/Group Description:	TAK-079 placebo-matching injection, subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks. Placebo data was pooled across all the dose levels.	TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
Overall Number of Participants Analyzed	5	6	5	5
Measure Type: Count of Participants; Unit of Measure: Participants
Baseline	3	0	1	1
EOT	3	2	0	2

Adverse Events

Time Frame	From the study start up to end of the study (up to Week 36)
Adverse Event Reporting Description	Safety analysis set included all subjects who were enrolled and received at least 1 dose of study drug.
Arm/Group Title	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
Arm/Group Description	TAK-079 placebo-matching injection, subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks. Placebo data was pooled across all the dose levels.	TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.	TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
All-Cause Mortality
	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/5 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Serious Adverse Events
	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	1/5 (20.00%)
Cardiac disorders
Palpitations † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	0/5 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/5 (20.00%)
1 Term from vocabulary, MedDRA 24; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Pooled Placebo	TAK-079 45mg	TAK-079 90 mg	TAK-079 135 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/5 (60.00%)	4/6 (66.67%)	6/6 (100.00%)	2/5 (40.00%)
Blood and lymphatic system disorders
Lymphadenopathy † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Cardiac disorders
Palpitations † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Gastrointestinal disorders
Nausea † 1	1/5 (20.00%)	3/6 (50.00%)	0/6 (0.00%)	0/5 (0.00%)
Abdominal pain † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Bezoar † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Diarrhoea † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Diverticulum intestinal † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Flatulence † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Impaired gastric emptying † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Large intestinal polyp † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
General disorders
Pyrexia † 1	0/5 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	1/5 (20.00%)
Fatigue † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Infections and infestations
Urinary tract infection † 1	0/5 (0.00%)	2/6 (33.33%)	1/6 (16.67%)	1/5 (20.00%)
Cellulitis † 1	0/5 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/5 (0.00%)
Herpes zoster † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Sinusitis † 1	0/5 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/5 (0.00%)
Vulvovaginal mycotic infection † 1	1/5 (20.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Tooth infection † 1	1/5 (20.00%)	0/6 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Injury, poisoning and procedural complications
Arthropod bite † 1	0/5 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/5 (0.00%)
Muscle strain † 1	1/5 (20.00%)	0/6 (0.00%)	1/6 (16.67%)	0/5 (0.00%)
Skin laceration † 1	0/5 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/5 (0.00%)
Vaccination complication † 1	1/5 (20.00%)	0/6 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Musculoskeletal and connective tissue disorders
Chondropathy † 1	0/5 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/5 (0.00%)
Joint swelling † 1	0/5 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/5 (0.00%)
Pain in extremity † 1	0/5 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/5 (0.00%)
Systemic lupus erythematosus † 1	1/5 (20.00%)	0/6 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Nervous system disorders
Headache † 1	1/5 (20.00%)	0/6 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
Psychiatric disorders
Adjustment disorder with depressed mood † 1	0/5 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/5 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	0/5 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	1/5 (20.00%)
Oropharyngeal pain † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Rhinorrhoea † 1	0/5 (0.00%)	1/6 (16.67%)	0/6 (0.00%)	0/5 (0.00%)
Skin and subcutaneous tissue disorders
Rash † 1	0/5 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/5 (0.00%)
Systemic lupus erythematosus rash † 1	0/5 (0.00%)	0/6 (0.00%)	1/6 (16.67%)	0/5 (0.00%)
Vascular disorders
Hypertension † 1	1/5 (20.00%)	0/6 (0.00%)	0/6 (0.00%)	0/5 (0.00%)
1 Term from vocabulary, MedDRA24.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.

Results Point of Contact

• Name/Title: Contact
• Organization: Takeda
• Phone: +1-877-825-3327
• EMail: medinfoUS@takeda.com

• Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
• ClinicalTrials.gov Identifier: NCT03724916
• Other Study ID Numbers: TAK-079-2001; U1111-1220-2497 ( Other Identifier: World Health Organization )
• First Submitted: October 18, 2018
• First Posted: October 30, 2018
• Results First Submitted: November 3, 2022
• Results First Posted: March 29, 2024
• Last Update Posted: March 29, 2024