Overview

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 Intol

Status:
Enrolling by invitation
Trial end date:
2029-12-11
Target enrollment:
0
Participant gender:
All
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 refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with systemic lupus erythematosus (SLE); to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biogen
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.