Litifilimab for Systemic Lupus Erythematosus
(AMETHYST LTE Trial)

Recruiting in Palo Alto (17 mi)

+44 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Biogen

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301. The main objective of the study is learning more about the long-term safety of litifilimab. The main question researchers want to answer is: - How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are unwanted medical problems that may or may not be caused by the study drug. Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). Researchers will assess the effect litifilimab and CLE has on the quality of life of participants using a group of questionnaires. They will also study how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab. The study will be done as follows: * The last visit of parent study 230LE301 will be the first visit of study 230LE305. * All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug. * The treatment period will last up to 104 weeks, or 2 years. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 33 study visits. * The total study duration for participants will be up to 128 weeks.

Eligibility Criteria

This trial is for adults who finished the parent study (230LE301) with active subacute or chronic cutaneous lupus erythematosus, and are not responding well to antimalarial therapy. They should understand the study's risks, give informed consent, and allow use of their health information. Those with new medical issues or who left the earlier study early can't join.

Inclusion Criteria

I understand the study's risks and goals and agree to share my health information.

I completed a specific study treatment and attended all required visits.

Exclusion Criteria

Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the long-term extension (LTE) study unsuitable in the opinion of the Investigator.

You were part of the earlier part of the study but did not finish it before Week 52.

If you stopped taking the study medication before 48 weeks in a previous related study, you cannot participate.

Participant Groups

The trial tests long-term safety and effectiveness of BIIB059 (litifilimab) in patients from a previous study. It looks at how litifilimab affects disease activity over time, prevents damage and flares, impacts steroid use, quality of life, lab parameters, immune response to treatment, and drug levels in the body.

1Treatment groups

Experimental Treatment

Group I: BIIB059Experimental Treatment1 Intervention

Participants will receive BIIB059 subcutaneously, once every 4 weeks up to Week 100.