Lupus Erythematosus, Systemic, Systemic Lupus Erythematosus
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to evaluate the safety and tolerability of TAK-079 in comparison with matching placebo, administered once every 3 weeks over a 12-week dosing period in participants with active SLE who are receiving stable background therapy for SLE.
Detailed description
TAK-079 is being tested in a study population with moderate to severe SLE. This study will evaluate the safety and biologic activity of TAK-079 or matching placebo in combination with stable SLE background therapy. The study will enroll approximately 24 participants across 3 sequentially enrolling cohorts. Each cohort will enroll 8 participants, where 6 participants will be assigned to TAK-079 injection, and 2 participants will be assigned to Placebo. Participants will receive TAK-079 or matching placebo in combination with principal investigator directed background therapy for SLE. This multi-center trial will be conducted in the United States. Participants will make multiple visits to the clinic, and will be followed up for the safety assessment for the additional 12 weeks up to Week 24 after receiving their last dose of study drug. Based on the clinical assessments, participants may complete or may advance to long-term safety follow up period for an additional 12-week safety monitoring period up to Week 36.
Interventions
DRUGTAK-079
TAK-079 subcutaneous injection.
DRUGTAK-079 Placebo
TAK-079 placebo-matching subcutaneous injection.
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The participant been diagnosed with SLE as defined by either the 2012 Systemic Lupus International Collaborating Clinics or the American College of Rheumatology diagnostic criteria. 2. The participant has a systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than or equal to (\>=) 6. 3. The participant is positive for anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies and/or anti-extractable nuclear antigens (ENA) antibodies.
Exclusion criteria
1. The participant had an opportunistic infection less than or equal to (\<=)12 weeks before initial study dosing or is currently undergoing treatment for a chronic opportunistic infection, such as tuberculosis (TB), pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria. 2. The participant currently has, or recently had, an acute or chronic infection requiring one or more of the following interventions: Hospitalization \<=30 days before the screening visit. - Administered parenteral (IV or intramuscular) antibacterial, antiviral, antifungal, or antiparasitic agents \<=30 days before the screening visit. 3. The participant has drug-induced SLE or any other rheumatologic or autoimmune disease (excluding secondary Sjögren syndrome or mixed connective tissue disease).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | From the study start to end of the study (up to Week 36) | 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. |
| Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) | From the study start up to end of the study (up to Week 36) | 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. |
| Percentage of Participants With ≥ 1 Adverse Event (AE) Leading to Treatment Discontinuation | From the study start up to end of the study (up to Week 36) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Baseline up to Day 85 (EOT) | 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. |
| Cmax: Maximum Observed Plasma Concentration for TAK-079 | 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 | — |
| Number of Participants With Positive Anti-drug Antibodies | Baseline up to Day 85 (EOT) | — |
| Change From Baseline in Cytokines Level | Baseline up to Day 85 | — |
| AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 | 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. | — |
| Number of Participants With Change From Baseline In Immune Cell Subsets | Baseline up to Day 85 (End of Treatment [EOT]) | 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Pooled Placebo 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. | 5 |
| TAK-079 45mg 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. | 6 |
| TAK-079 90 mg 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. | 6 |
| TAK-079 135 mg 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. | 5 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Randomized but not Treated | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Pooled Placebo | TAK-079 45mg | TAK-079 90 mg | TAK-079 135 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 36.4 years STANDARD_DEVIATION 6.58 | 51.0 years STANDARD_DEVIATION 22.01 | 46.7 years STANDARD_DEVIATION 6.53 | 49.6 years STANDARD_DEVIATION 13.5 | 46.2 years STANDARD_DEVIATION 14.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 6 Participants | 4 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 4 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 5 Participants | 4 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 3 / 5 | 4 / 6 | 6 / 6 | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 | 1 / 6 | 0 / 6 | 1 / 5 |
Outcome results
Primary
Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
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)
Population: Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo | Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAEs | 3 Participants |
| Pooled Placebo | Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAEs | 0 Participants |
| TAK-079 45mg | Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAEs | 1 Participants |
| TAK-079 45mg | Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAEs | 4 Participants |
| TAK-079 90 mg | Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAEs | 0 Participants |
| TAK-079 90 mg | Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAEs | 6 Participants |
| TAK-079 135 mg | Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAEs | 2 Participants |
| TAK-079 135 mg | Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAEs | 1 Participants |
Primary
Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)
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)
Population: Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) | 0 Participants |
| TAK-079 45mg | Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) | 0 Participants |
| TAK-079 90 mg | Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) | 0 Participants |
| TAK-079 135 mg | Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) | 0 Participants |
Primary
Percentage of Participants With ≥ 1 Adverse Event (AE) Leading to Treatment Discontinuation
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)
Population: Safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo | Percentage of Participants With ≥ 1 Adverse Event (AE) Leading to Treatment Discontinuation | 0 Participants |
| TAK-079 45mg | Percentage of Participants With ≥ 1 Adverse Event (AE) Leading to Treatment Discontinuation | 0 Participants |
| TAK-079 90 mg | Percentage of Participants With ≥ 1 Adverse Event (AE) Leading to Treatment Discontinuation | 0 Participants |
| TAK-079 135 mg | Percentage of Participants With ≥ 1 Adverse Event (AE) Leading to Treatment Discontinuation | 1 Participants |
Secondary
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079
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.
Population: As pre-specified in SAP, data for AUClast was not evaluated due to sparse PK sampling.
Secondary
Change From Baseline in Cytokines Level
Time frame: Baseline up to Day 85
Population: 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.
Secondary
Cmax: Maximum Observed Plasma Concentration for TAK-079
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-079 | Day 1 | 57.5 nanograms per millilitre (ng/mL) | Standard Deviation 71.7 |
| Pooled Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-079 | Day 22 | 95.4 nanograms per millilitre (ng/mL) | Standard Deviation 187 |
| Pooled Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-079 | Day 64 | 16.4 nanograms per millilitre (ng/mL) | Standard Deviation 17.4 |
| Pooled Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-079 | Day 43 | 10.6 nanograms per millilitre (ng/mL) | Standard Deviation 17.5 |
| TAK-079 45mg | Cmax: Maximum Observed Plasma Concentration for TAK-079 | Day 22 | 1570 nanograms per millilitre (ng/mL) | Standard Deviation 2930 |
| TAK-079 45mg | Cmax: Maximum Observed Plasma Concentration for TAK-079 | Day 43 | 1440 nanograms per millilitre (ng/mL) | Standard Deviation 2550 |
| TAK-079 45mg | Cmax: Maximum Observed Plasma Concentration for TAK-079 | Day 64 | 568 nanograms per millilitre (ng/mL) | Standard Deviation 841 |
| TAK-079 45mg | Cmax: Maximum Observed Plasma Concentration for TAK-079 | Day 1 | 660.0 nanograms per millilitre (ng/mL) | Standard Deviation 1050 |
| TAK-079 90 mg | Cmax: Maximum Observed Plasma Concentration for TAK-079 | Day 1 | 6130 nanograms per millilitre (ng/mL) | Standard Deviation 5170 |
| TAK-079 90 mg | Cmax: Maximum Observed Plasma Concentration for TAK-079 | Day 64 | 3100 nanograms per millilitre (ng/mL) | Standard Deviation 3900 |
| TAK-079 90 mg | Cmax: Maximum Observed Plasma Concentration for TAK-079 | Day 43 | 559 nanograms per millilitre (ng/mL) | Standard Deviation 714 |
| TAK-079 90 mg | Cmax: Maximum Observed Plasma Concentration for TAK-079 | Day 22 | 6330 nanograms per millilitre (ng/mL) | Standard Deviation 9450 |
Secondary
Number of Participants With Change From Baseline In Immune Cell Subsets
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])
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Lymphocytes concentration | 4 Participants |
| Pooled Placebo | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in NK cells concentration | 4 Participants |
| Pooled Placebo | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Monocytes concentration | 4 Participants |
| Pooled Placebo | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Plasmablasts concentration | 4 Participants |
| Pooled Placebo | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in T cells concentration | 4 Participants |
| Pooled Placebo | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in B cells concentration | 4 Participants |
| Pooled Placebo | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Plasma cell concentration | 4 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in B cells concentration | 6 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in T cells concentration | 6 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Plasmablasts concentration | 6 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in NK cells concentration | 6 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Lymphocytes concentration | 6 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Monocytes concentration | 6 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Plasma cell concentration | 6 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in B cells concentration | 4 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Plasma cell concentration | 4 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Plasmablasts concentration | 4 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in NK cells concentration | 4 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in T cells concentration | 4 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Monocytes concentration | 4 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Lymphocytes concentration | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in NK cells concentration | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Lymphocytes concentration | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Monocytes concentration | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Plasmablasts concentration | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in Plasma cell concentration | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in T cells concentration | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline In Immune Cell Subsets | Participants who had change in B cells concentration | 4 Participants |
Secondary
Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy
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)
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: Plasma Cells | 4 Participants |
| Pooled Placebo | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: Plasmablasts | 4 Participants |
| Pooled Placebo | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+NK cells | 4 Participants |
| Pooled Placebo | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+B cells | 4 Participants |
| Pooled Placebo | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+T cells | 4 Participants |
| Pooled Placebo | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+Monocytes | 4 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+Monocytes | 5 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+B cells | 5 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: Plasma Cells | 3 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+NK cells | 5 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: Plasmablasts | 5 Participants |
| TAK-079 45mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+T cells | 5 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: Plasmablasts | 4 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+NK cells | 4 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+B cells | 4 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+Monocytes | 4 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+T cells | 4 Participants |
| TAK-079 90 mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: Plasma Cells | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+T cells | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+Monocytes | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: Plasmablasts | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+B cells | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: Plasma Cells | 4 Participants |
| TAK-079 135 mg | Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy | Participants who had change in receptor occupancy: CD38+NK cells | 4 Participants |
Secondary
Number of Participants With Positive Anti-drug Antibodies
Time frame: Baseline up to Day 85 (EOT)
Population: Immunogenicity set consisted of all participants who received study drug and had a baseline and at least 1 postbaseline immunogenicity sample assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo | Number of Participants With Positive Anti-drug Antibodies | Baseline | 3 Participants |
| Pooled Placebo | Number of Participants With Positive Anti-drug Antibodies | EOT | 3 Participants |
| TAK-079 45mg | Number of Participants With Positive Anti-drug Antibodies | EOT | 2 Participants |
| TAK-079 45mg | Number of Participants With Positive Anti-drug Antibodies | Baseline | 0 Participants |
| TAK-079 90 mg | Number of Participants With Positive Anti-drug Antibodies | Baseline | 1 Participants |
| TAK-079 90 mg | Number of Participants With Positive Anti-drug Antibodies | EOT | 0 Participants |
| TAK-079 135 mg | Number of Participants With Positive Anti-drug Antibodies | Baseline | 1 Participants |
| TAK-079 135 mg | Number of Participants With Positive Anti-drug Antibodies | EOT | 2 Participants |