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 (LTE AMETHYST)

Launched by BIOGEN · Sep 12, 2023

Keywords

ClinConnect Summary

The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy.

The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and r...

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.