At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 23 enrolled
Drug / intervention
TAK-079 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus
In Brief
A Phase 1 clinical trial evaluating TAK-079 and TAK-079 Placebo for Systemic Lupus Erythematosus and Lupus Erythematosus, Systemic. Completed, enrolled 23 participants across 19 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartNov 2018
Primary CompletionNov 2021
TodayJul 2026
First PostedOct 30, 2018
Enrollment StartNov 26, 2018
Primary CompletionNov 4, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.7 years ago
Interventions
TAK-079drug
TAK-079 subcutaneous injection.
TAK-079 Placebodrug
TAK-079 placebo-matching subcutaneous injection.