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

Phase 1

Recruiting

Conditions: 1. Lupus Erythematosus, Cutaneous, Subacute2. Chronic Cutaneous Lupus Erythematosus
MedDRA version: 20.0Level: SOCClassification code: 10040785Term: Skin and subcutaneous tissue disorders Class: 16
MedDRA version: 21.1Level: PTClassification code: 10056509Term: Cutaneous lupus erythematosus Class: 100000004858
MedDRA version: 21.1Level: PTClassification code: 10057903Term: Subacute cutaneous lupus erythematosus Class: 100000004858
MedDRA version: 21.1Level: PTClassification code: 10057929Term: Chronic cutaneous lupus erythematosus Class: 100000004858
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: CTIS2023-504863-17-00

Lead Sponsor: Biogen Idec Research Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 347

Inclusion Criteria

Participants who completed the parent study (230LE301, 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

Exclusion Criteria

Early Part A or Part B parent study (230LE301) 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., Other protocol defined Exclusion criteria may apply