Phase 1
Completed N=23
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)
Systemic Lupus Erythematosus · Lupus Erythematosus, Systemic
Source: ClinicalTrials.gov NCT03724916 ↗
Enrolled (actual)
23
Serious AEs
9.1%
Results posted
Mar 2024
Primary outcomePrimary: Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) — 3; 4; 6; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) |
3; 4; 6; 2; 0; 1 | — |
| PRIMARY Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) |
0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With ≥ 1 Adverse Event (AE) Leading to Treatment Discontinuation |
0; 0; 0; 1 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for TAK-079 |
57.5; 660.0; 6130; 95.4; 1570; 6330 | — |
| SECONDARY AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 |
— | — |
| SECONDARY Number of Participants With Change From Baseline In Immune Cell Subsets |
4; 6; 4; 4; 4; 6 | — |
| SECONDARY Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy |
4; 3; 4; 4; 4; 5 | — |
| SECONDARY Change From Baseline in Cytokines Level |
— | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies |
3; 0; 1; 1; 3; 2 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- The participant has a systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than or equal to (>=) 6.
- The participant is positive for anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies and/or anti-extractable nuclear antigens (ENA) antibodies.
Exclusion Criteria
- 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.
- 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.
- The participant has drug-induced SLE or any other rheumatologic or autoimmune disease (excluding secondary Sjögren syndrome or mixed connective tissue disease).
Data sourced from ClinicalTrials.gov (NCT03724916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.