Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-079 · 5 trials · 6 indications
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with the treatment. SAE means any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening; c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event. TEAEs were defined as an AE having a start date and time equal to or later than the start date and time of the first dose of investigational medicinal product (IMP). Percentages were rounded off to the nearest single decimal place.
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.
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.
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.
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.
RP2D of TAK-079 along with lenalidomide-dexamethasone (LenDex) or TAK-079 along with bortezomib, lenalidomide, and dexamethasone (VRd) will be based on number of participants with dose limiting toxicity (DLT). DLTs will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Adverse event (AE) Grades will be evaluated as per NCI CTCAE, version 4.03.
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. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE was assessed according to severity; mild (transient and easily tolerated by the participant), moderate (causes the participant discomfort and interrupts the participant's usual activities) and severe (causes considerable interference with the participant's usual activities).
| Arm | Type | Description |
|---|---|---|
| Part A & B: Double Blind Period: Placebo | PLACEBO_COMPARATOR | Participants received TAK-079 placebo-matching injection subcutaneously (SC), once weekly (QW) for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded short follow-up period (SFP) up to Week 16. Participants who opted to receive treatment with TAK-079 were then randomized to receive TAK-079, SC injection, QW for 8 weeks in Open-label Extension (OLE) Period of Part A or Part B. Participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded long follow-up period (LFP) up to Week 32. |
| Part A: Double Blind Period: TAK-079 100 mg | EXPERIMENTAL | Participants received TAK-079 100 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants who opted to receive treatment with TAK-079 were then randomized to receive TAK-079, SC injection, QW for 8 weeks in OLE Period of Part A or Part B. Participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| Part A: Double Blind Period: TAK-079 300 mg | EXPERIMENTAL | Participants received TAK-079 300 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants who opted to receive treatment with TAK-079 were then randomized to receive TAK-079, SC injection, QW for 8 weeks in OLE Period of Part A or Part B. Participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| Part B: Double Blind Period: TAK-079 600 mg | EXPERIMENTAL | Participants received TAK-079 600 mg, SC injection, QW for 8 weeks. Following treatment participants were followed up for 8 weeks in a double blinded SFP up to Week 16. Participants who opted to receive treatment with TAK-079 were then randomized to receive TAK-079, SC injection, QW for 8 weeks in OLE Period of Part A or Part B. Participants who did not opt to receive treatment with TAK-079 were followed up for another 16 weeks in an unblinded LFP up to Week 32. |
| Part A: Open-label Extension (OLE) Period: TAK-079 100 mg | EXPERIMENTAL | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 100 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| Part A: OLE Period: TAK-079 300 mg | EXPERIMENTAL | Participants who received placebo in double-blind Part A and opted to receive treatment with TAK-079 were randomized to receive TAK-079 300 mg, SC injection, QW for 8 weeks in OLE Period of Part A. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| Part B: OLE Period: TAK-079 600 mg | EXPERIMENTAL | Participants who received placebo in double-blind Part B and opted to receive treatment with TAK-079 received TAK-079 600 mg, SC injection, QW for 8 weeks in OLE Period of Part B. Following treatment participants were followed up for 8 weeks in a SFP and then for another 16 weeks in a LFP. |
| TAK-079 Placebo-matching | PLACEBO_COMPARATOR | TAK-079 placebo-matching injection, subcutaneously (SC), once weekly in combination with standard background therapy for 8 weeks. |
| TAK-079 300 mg | EXPERIMENTAL | TAK-079 300 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks. |
| TAK-079 600 mg | EXPERIMENTAL | TAK-079 600 mg injection, SC, once weekly in combination with standard background therapy for 8 weeks. |
| 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. |
| Treatment Phase: TAK-079 and LenDex | EXPERIMENTAL | TAK-079, subcutaneously, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter, along with lenalidomide, orally, once daily for 21 days and dexamethasone, orally or intravenously, once on Days 1, 8, 15 and 22 in each 28-day treatment until progressive disease (PD) or unacceptable toxicity, withdrawal of consent, death, or termination of the study by sponsor for up to 2 years. The dosage of dexamethasone can be reduced for participants who are greater than (\>) 75 years, have poorly controlled diabetes, or had prior intolerance to or AE from corticosteroid therapy. |
| Treatment Phase: TAK-079 and VRd | EXPERIMENTAL | TAK-079 subcutaneously, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter, along with bortezomib, subcutaneously, once on Days 1, 8, and 15, for a maximum of 8 cycles, lenalidomide, orally, once daily for 21 days, and dexamethasone, orally or intravenously, once on Days 1, 8, 15 and 22 in each 28-day treatment until PD or unacceptable toxicity, withdrawal of consent, death, or termination of the study by sponsor for up to 2 years. The dosage of dexamethasone can be reduced for participants who are \>75 years, have poorly controlled diabetes, or had prior intolerance to or AE from corticosteroid therapy. |
| Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex) | EXPERIMENTAL | TAK-079 dosing and, if applicable, backbone therapy will be administered as per the schedule outlined in the parent study. |
| Cohort 1: TAK-079 0.0003 mg/kg | EXPERIMENTAL | TAK-079 0.0003 mg/kg, infusion, intravenously, once. |
| Cohort 2-9: TAK-079 TBD | EXPERIMENTAL | TAK-079, infusion, intravenously or subcutaneously, once. Dose to be determined from data collected in previous IV or SC Cohort(s) |
| Placebo to TAK-079 | PLACEBO_COMPARATOR | Placebo to TAK-079, infusion, intravenously or subcutaneously, once. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | TAK-079 placebo-matching SC injection. |
| TAK-079 | DRUG | TAK-079 SC injection. |
| TAK-079 Placebo | DRUG | TAK-079 placebo-matching subcutaneous injection |
| Lenalidomide | DRUG | Lenalidomide orally. |
| Dexamethasone | DRUG | Dexamethasone orally. |
| Bortezomib | DRUG | Bortezomib subcutaneously. |
| Pomalidomide | DRUG | Pomalidomide orally. |
| Placebo to TAK-079 | DRUG | Placebo to TAK-079 solution |
Inclusion Criteria: 1. Diagnosed with ITP that has persisted for ≥3 months, diagnosed in accordance to The American Society of Hematology 2011 Evidence-based Practice Guideline for Immune Thrombocytopenia or the International Consensus Report on The Investigation and Management of Primary Immune Th...
TAK-079 is an investigational small molecule being developed by Takeda for autoimmune diseases, including systemic lupus erythematosus, primary immune thrombocytopenia, myasthenia gravis, and multiple myeloma. It is currently in clinical development and has not been approved by the FDA.
TAK-079 is a small molecule immunology therapy. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its effects on autoimmune conditions and multiple myeloma.
TAK-079 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various autoimmune and hematologic conditions.
TAK-079 has completed Phase 1 trials in healthy volunteers, systemic lupus erythematosus, and multiple myeloma, and a Phase 2 trial in primary immune thrombocytopenia. All trials are completed, and the drug remains investigational.
TAK-079 has completed four clinical trials: NCT02219256 in healthy participants, NCT03724916 in systemic lupus erythematosus, NCT03984097 in newly diagnosed multiple myeloma, and NCT04278924 in primary immune thrombocytopenia. All trials are completed.
TAK-079 is not FDA approved. It is an investigational drug that has completed early-stage clinical trials. Further development and regulatory review would be required before it could be considered for approval.