Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1220-2497 | Other Identifier | World Health Organization |
Not provided
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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.
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.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pooled Placebo | Placebo Comparator | 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 will be pooled across all the dose levels. |
|
| TAK-079 45 mg | Experimental | 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 | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-079 | Drug | TAK-079 subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the study start to end of the study (up to Week 36) |
| 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. | From the study start up to end of the study (up to Week 36) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| University of Alabama at Birmingham |
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Not provided
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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 took part in the study at 13 investigative sites in United States from 26 November 2018 to 04 November 2021.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | TAK-079 45mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2019 | Nov 3, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
| TAK-079 Placebo | Drug | TAK-079 placebo-matching subcutaneous injection. |
|
| From the study start up to end of the study (up to Week 36) |
| 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 | 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. | Baseline up to Day 85 (End of Treatment [EOT]) |
| 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. | Baseline up to Day 85 (EOT) |
| Change From Baseline in Cytokines Level | Baseline up to Day 85 |
| Number of Participants With Positive Anti-drug Antibodies | Baseline up to Day 85 (EOT) |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| University of California San Diego | La Jolla | California | 92037 | United States |
| ACRC Studies | Poway | California | 92064 | United States |
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| Clinical Research of West Florida - Clearwater | Clearwater | Florida | 33765 | United States |
| CRIA Research | Fort Lauderdale | Florida | 33309 | United States |
| Millennium Research | Ormond Beach | Florida | 32174 | United States |
| North Georgia Rheumatology Group-Duluth | Lawrenceville | Georgia | 30046 | United States |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Northwell Health | Great Neck | New York | 11021 | United States |
| State University of New York Upstate Medical Center (SUNY) | Syracuse | New York | 13210 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Accurate Clinical Research | Houston | Texas | 77034 | United States |
| Southwest Rheumatology Research, LLC | Mesquite | Texas | 75150 | United States |
| Arthritis Northwest Rheumatology | Spokane | Washington | 99204 | United States |
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. |
| FG002 | 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. |
| FG003 | 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. |
| Safety Analysis Set | Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug. |
|
| Pharmacokinetic (PK) Analysis Set | PK analysis set included all participants who received study drug and had at least 1 measurable serum concentration. |
|
| Pharmacodynamic (PD) Analysis Set | PD analysis set included all participants who received study drug and had at least 1 postdose PD measurement. |
|
| Immunogenicity Analysis Set | Immunogenicity analysis set consisted of all participants who received study drug and had a baseline and at least 1 postbaseline immunogenicity sample assessment. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | From the study start to end of the study (up to Week 36) |
|
|
| ||||||||||||||||||||||||||||||||||
| 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. | Safety analysis set included all participants who were enrolled and received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | From the study start up to end of the study (up to Week 36) |
| ||||||||||||||||||||||||||||||||||||
| 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. | Safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | From the study start up to end of the study (up to Week 36) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Cmax: Maximum Observed Plasma Concentration for TAK-079 | 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. | Posted | Mean | Standard Deviation | nanograms per millilitre (ng/mL) | 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 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 | As pre-specified in SAP, data for AUClast was not evaluated due to sparse PK sampling. | Posted | 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. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | No | Baseline up to Day 85 (End of Treatment [EOT]) |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | No | Baseline up to Day 85 (EOT) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cytokines Level | 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. | Posted | No | Baseline up to Day 85 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-drug Antibodies | Immunogenicity set consisted of all participants who received study drug and had a baseline and at least 1 postbaseline immunogenicity sample assessment. | Posted | Count of Participants | Participants | No | Baseline up to Day 85 (EOT) |
|
From the study start up to end of the study (up to Week 36)
Safety analysis set included all subjects who were enrolled and received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG001 | 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. | 0 | 6 | 1 | 6 | 4 | 6 |
| EG002 | 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. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | 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. | 0 | 5 | 1 | 5 | 2 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA24.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA24.0 | Systematic Assessment |
| |
| Bezoar | Gastrointestinal disorders | MedDRA24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA24.0 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA24.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA24.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA24.0 | Systematic Assessment |
| |
| Large intestinal polyp | Gastrointestinal disorders | MedDRA24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA24.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA24.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA24.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA24.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA24.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA24.0 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA24.0 | Systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA24.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA24.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA24.0 | Systematic Assessment |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA24.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA24.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedDRA24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA24.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact | Takeda | +1-877-825-3327 | medinfoUS@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2021 | Nov 3, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| SAEs |
|
| OG002 | 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. |
| OG003 | 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. |
|
|
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.
| OG003 | 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. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
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. |
|
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. |
| OG003 | 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. |
|
|
| 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. |
| OG003 | 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. |
|
|
|
|
|