A Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adults With Active Subacute Cutaneous Lupus Erythematosus (CLE) and/or Chronic CLE With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST LTE)
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
About this trial
This is an interventional treatment trial for Subacute Cutaneous Lupus Erythematosus
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.
Sites / Locations
- David Fivenson, MD, Dermatology, PLLC
Arms of the Study
Arm 1
Experimental
BIIB059
Participants will receive BIIB059 subcutaneously, once every 4 weeks up to Week 100.