A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

Launched by BIOGEN · Sep 12, 2023

Keywords

ClinConnect Summary

This long-term extension study is testing litifilimab (BIIB059) for adults with active cutaneous lupus erythematosus (CLE)—including subacute CLE and chronic CLE—with or without mild systemic lupus features. It only includes people who completed the earlier parent study (230LE301) on litifilimab. The study is open-label and single-arm, meaning everyone receives the drug and there is no comparison group. Participants will inject litifilimab under the skin every 4 weeks for up to 2 years, with an additional safety follow-up period of up to 6 months. The total time in the study can be up to about 128 weeks, and enrollment is by invitation.

The main goal is to learn about the long-term safety and tolerability of litifilimab. Researchers will also look at how CLE symptoms behave over time, using skin scores like CLASI and CLA-IGA-R, as well as quality-of-life measures and how the treatment affects steroid use, lab tests, and immune response. In practice, researchers will track adverse events (and any serious events), ongoing disease activity, potential disease damage, potential lupus flares, and how patients feel and function in daily life. If you’re eligible, you’d come from many sites around the world, and the study is overseen by a data monitoring committee to ensure safety.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Participants who completed the parent study (230LE301 \[NCT05531565\], Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52).
• • Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
• Key Exclusion Criteria:
• • Early Part A or Part B parent study (230LE301 \[NCT05531565\]) treatment terminators (participants who discontinued study treatment before Week 48).
• • Early Part A or Part B parent study terminators \[participants who withdrew from parent study participation before Week 52 and did not complete the parent study extended treatment period (ETP)\].
• • 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.
• • NOTE: Other protocol- defined Inclusion/Exclusion criteria may apply.