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

Browse trials for

• Lupus Erythematosus, Systemic 1,207

Keywords

• Drug therapy

Lupus Erythematosus, Systemic

1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.

This study's enrollment of 23 is below the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.

Lead sponsor

Millennium Pharmaceuticals, Inc. is the lead sponsor of 178 studies on the registry; none are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 73 (99%) have results posted.

First submitted after Millennium Pharmaceuticals, Inc. became part of Takeda.

Study arms

• Placebo comparator
  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 will be pooled across all the dose levels.

  Drug: TAK-079 Placebo

• Experimental
  TAK-079 45 mg

  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.

  Drug: TAK-079

• Experimental
  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.

  Drug: TAK-079

• Experimental
  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.

  Drug: TAK-079

Interventions

• DrugTAK-079

  TAK-079 subcutaneous injection.

• DrugTAK-079 Placebo

  TAK-079 placebo-matching subcutaneous injection.

Primary outcomes

1. 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)

2. 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)

3. 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)

Secondary outcomes

1. 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

2. 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.

3. 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])

4. 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)

5. Change From Baseline in Cytokines Level

   Time frame: Baseline up to Day 85

6. Number of Participants With Positive Anti-drug Antibodies

   Time frame: Baseline up to Day 85 (EOT)

Baseline characteristics

Study documents

• Study protocol ↗ · Mar 10, 2019
• Statistical analysis plan ↗ · Nov 19, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Access criteria: 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.

Data sharing details ↗ · vivli.org