Approval Probability
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Also known as Mezagitamab
TAK-079 · 11 trials · 11 indications
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2. A serious TEAE is a TEAE that meets 1 or more of the criteria: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or was otherwise considered medically important.
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to mezagitamab in the parent trial for Cohort 1 and in this trial for Cohort 2.
Proteinuria will be assessed by urine protein to creatinine ratio (UPCR) calculated from a 24-hour urine collection.
Durable platelet response is defined as platelet count greater than or equal to (≥)50,000/microliter (μL) on at least 4 of the 6 weekly platelet measurements between Weeks 19 and 24.
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational medicinal product (IMP).
A related AE is an AE that is considered related to the IMP. Related TEAEs are defined as related AEs with start dates at the time of or following the first exposure to IMP.
An SAE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
AEs of special interest are AEs that are considered specific to the IMP.
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.
The severity of TEAEs will be graded using National cancer institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
The severity of TEAEs will be graded using NCI-CTCAE version 5.0.
The severity of TEAEs will be graded using NCI-CTCAE version 5.0.
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.
TEAEs were any untoward medical occurrence (called an adverse event \[AE\]) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.
DLTs were defined as any of the following events: Grade 4 laboratory abnormalities, except those events that were clearly due to extraneous causes; nonhematologic TEAEs of grade greater than or equal to (\>=3) except grade 3 nausea/vomiting, fatigue lasting less than 72 hours, elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that resolves to grade less than or equal to (\<=)1 or baseline within 7 days, injection reaction (IR) that responds to symptomatic treatment; Hematologic TEAEs of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade \>=4, except grade \>=3 hemolysis, grade 3 low platelet or higher count with clinically meaningful bleeding; and an incomplete recovery from treatment-related toxicity causing a greater than (\>) 2-week delay in the next scheduled injection before the initiation of Cycle 2 will be considered a DLT.
AE Grades were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE.
TEAEs were any untoward medical occurrence (called an AE) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. A SAE is an AE 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; or congenital anomaly; or a medically important event.
TEAEs leading to discontinuation were any untoward medical occurrence (called an AE) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug leading to discontinuation of any of the study treatment when given in combination.
TEAEs were any untoward medical occurrence (called an AE) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. Dose modification includes dose delayed, reduced, and drug discontinued permanently. Dose reduced includes scenarios where the dose was skipped, held, or missed. Dose modifications also refer to a modification of any drug in the study treatment when given in combination.
ORR is defined as the percentage of participants who achieved a partial response (PR) better during the study. PR is defined as \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 milligram per (mg/) 24 hours. If serum and urine M protein are not measurable, \>= 50% decrease in difference between involved and uninvolved free light chain (FLC) levels is required in place of M protein criteria.
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 |
|---|---|---|
| Mezagitamab | EXPERIMENTAL | Eligible participants who completed the TAK-079-3002 or TAK-079-1004 studies can receive on-demand treatment in this continuation study. The on-demand treatment course may be repeated as needed based on the pre-specified on-demand dosing criteria and investigator's clinical judgement. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive mezagitamab-matching placebo injections, SC for approximately 22 weeks. |
| Open-label Mezagitamab | EXPERIMENTAL | Participants will receive mezagitamab injections, SC for approximately 22 weeks. |
| Arm A: Mezagitamab + Placebo | EXPERIMENTAL | Participants will receive mezagitamab up to Week 24, followed by placebo up to Week 48, followed by an observation period up to Week 70. |
| Arm B: Mezagitamab | EXPERIMENTAL | Participants will receive mezagitamab up to Week 48, followed by an observation period up to Week 70. |
| Arm C: Placebo | ACTIVE_COMPARATOR | Participants will receive placebo up to Week 48, followed by an observation period up to Week 70. |
| 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. |
| Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg | EXPERIMENTAL | Mezagitamab 45 mg, subcutaneously (SC), once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until progressive disease (PD), unacceptable toxicities or withdrawal due to other reasons. |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | EXPERIMENTAL | Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | EXPERIMENTAL | Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | EXPERIMENTAL | Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | EXPERIMENTAL | Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | EXPERIMENTAL | Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD. |
| Phase 2a: Mezagitamab | EXPERIMENTAL | Mezagitamab, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons. TAK-079 dose for this phase was to be determined based on review of the available safety, efficacy, pharmacokinetic, and pharmacodynamic data obtained from the Phase 1 portion of the study. However, Phase 2a of the study was not opened for enrollment due to changes in the Sponsor's overall clinical development plan. |
| 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 |
|---|---|---|
| Mezagitamab | DRUG | Mezagitamab injection administered SC. |
| Placebo | DRUG | Mezagitamab-matching placebo injections administered SC. |
| 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 |
* Key Inclusion Criteria: 1\. The participant has completed TAK-079-3002 (end of trial \[EOT\]) or TAK-079-1004 (EOT). Participants from TAK-079-1004 must have had a response to mezagitamab as demonstrated by meeting the criteria for "platelet response" specified for that trial during either the ...
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TAK-079 is an investigational monoclonal antibody being developed by Takeda Pharmaceutical Company Limited. It is under study for several immunology and oncology indications, including autoimmune disease, multiple myeloma, myasthenia gravis, primary immune thrombocytopenia, and systemic lupus erythematosus. It remains in clinical development and is not an approved therapy.
TAK-079 is being studied for primary immune thrombocytopenia, generalized myasthenia gravis, systemic lupus erythematosus, and newly diagnosed multiple myeloma. These are investigational uses only. The clinical program has evaluated the antibody across autoimmune and plasma cell driven conditions, and no approved indication has been established for TAK-079.
TAK-079 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program studying the monoclonal antibody across immunology and multiple myeloma indications.
TAK-079 is in Phase 1 development overall, with completed Phase 2 studies also conducted in primary immune thrombocytopenia and generalized myasthenia gravis. The program includes completed Phase 1 trials in multiple myeloma and systemic lupus erythematosus. TAK-079 is investigational and has not been approved for any indication.
Completed TAK-079 trials include NCT04278924 in persistent or chronic primary immune thrombocytopenia, NCT04159805 in generalized myasthenia gravis, NCT03984097 in newly diagnosed multiple myeloma, and NCT03724916 in moderate to severe systemic lupus erythematosus. These studies enrolled adults and were conducted across sites in the United States, Europe, and Asia.
TAK-079 is not approved; it is an investigational monoclonal antibody still in clinical development. Its trials, including NCT04278924, NCT04159805, NCT03984097, and NCT03724916, have been completed, but completion of a study does not constitute regulatory approval. Takeda continues to hold the development program.