A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE)

Condition(s) studied

Investigational drug(s) / intervention(s)

Litifilimab: Administered as specified in the treatment arm.

Litifilimab-matching placebo: Administered as specified in the treatment arm.

Study summary

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 adults who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will include participants who completed the treatment periods of either one of those parent studies.

The main goal of the study is to learn more about the long-term safety of litifilimab in adults. The main question researchers want to answer is:

\- How many participants have adverse events and serious adverse events during the study? Adverse events are health problems that may or may not be caused by the study drug.

Researchers will also learn about:

* The effect of litifilimab on controlling symptoms of SLE and lowering its activity.
* How participants' immune systems respond to litifilimab.
* The effect of litifilimab on the quality of life of participants.

The study will be done as follows:

* This study begins when the participant has finished 1 of the parent studies (either 230LE303 or 230LE304).
* Participants who were getting either a high or low dose of litifilimab in either parent study will continue getting the same doses.
* Participants who were getting the placebo in the parent studies will be randomized to get either a high or low dose of litifilimab.
* Neither the researchers nor the participants will know which doses of litifilimab the participants are getting.
* All participants will get litifilimab as injections under the skin once every 4 weeks. The treatment period will last up to 260 weeks. Participants may continue to take their standard of care medications.
* There will be a follow-up safety period that lasts up to 24 weeks.
* In total, participants will have up to 67 study visits. At these visits, the study doctor will do tests to check the participants' overall health, including the status of their SLE symptoms. They will also measure the participants' height, weight, and vital signs and collect blood and urine samples. Participants will also complete questionnaires or answer questions about how they are feeling and about their daily lives.
* Each participant will be in the study for up to 284 weeks.

Optional Substudy:

* Some participants may be invited to join an optional "substudy" after being in the main study for at least 4 months.
* This substudy will test a new injector device for delivering litifilimab. The injector device is an automatic device that delivers the full dose in 1 injection without needing to push a plunger.
* Researchers will learn more about the safety of the injector device and how the body reacts to it. This will be compared to the current prefilled syringe method.
* The substudy will last up to 3 months and will include about 120 participants.

Eligibility

Primary outcome measure(s)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs) — Up to Week 284
  An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that started or worsened in severity after the first dose of study treatment through 28 days after the last dose of study treatment or end of study (EOS) date, whichever comes earlier.
• Number of Participants with Serious Adverse Events (SAEs) — Up to Week 284
  An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death (a life threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, and is a medically important event.

Trial sites (213)

+ 173 more sites — see the full list on the official registry below.

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