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A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
This record was last updated January 29, 2026 (before its estimated September 27, 2026 completion). Its status may not reflect the trial's current state.
Record History
NotablePrimary completion date: Sep 27, 2025 to Sep 27, 2026Secondary endpoints: 25 to 33 · Study description expanded, about 171 wordsv22Show 2 more changesShow less
MinorTrial status: Recruiting to Active, Not RecruitingEnrollment target: estimated 540 to confirmed 562 · Study sites: 179 to 177 · Primary completion date changed from estimate of Sep 30, 2026 to Sep 27, 2025v20Show 3 more changesShow less
Enrollment target: estimated 540 to confirmed 562
Study sites: 179 to 177
Primary completion date changed from estimate of Sep 30, 2026 to Sep 27, 2025
MinorSite details revised at 1 of 179 sitesv19
NotablePrimary completion date: Sep 18, 2025 to Sep 30, 2026Completion date: Mar 5, 2026 to Mar 16, 2027 · Site contacts updated at 3 of 179 sitesv18Show 2 more changesShow less
MinorInterventions: BIIB059 (litifilimab) (Drug), Placebo (Drug) to Litifilimab (Drug), Placebo (Drug)Eligibility criteria expanded, about 11 words · Secondary endpoints revised (25) · Study title revisedv15Show 3 more changesShow less
MinorStudy sites: 160 to 162Primary completion date: Jun 13, 2025 to Sep 18, 2025 · Completion date: Nov 28, 2025 to Mar 5, 2026 · Secondary endpoints: 22 to 25 · 1 morev12Show 4 more changesShow less
Primary completion date: Jun 13, 2025 to Sep 18, 2025
MinorStudy sites: 162 to 160Interventions: BIIB059 (Drug), BIIB059-Matching Placebo (Drug) to BIIB059 (litifilimab) (Drug), Placebo (Drug) · Study title expanded, about 1 wordv11Show 2 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 6 to 10 · Start date changed from estimate of Aug 2, 2021 to Jul 16, 2021v2Show 2 more changesShow less
Study sites: 6 to 10
Start date changed from estimate of Aug 2, 2021 to Jul 16, 2021
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants.
The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is:
\- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others.
Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires.
The study will be done as follows:
* After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine.
* All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications.
* Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
* There will be a follow-up safety period that lasts up to 24 weeks.
* In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.