Status:
ENROLLING_BY_INVITATION
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
Lead Sponsor:
Biogen
Conditions:
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have eithe...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 11 2029
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT06044337
Start Date
October 3 2023
End Date
December 11 2029
Last Update
December 17 2025
Active Locations (80)
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1
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States, 85032
2
Dermatology Research Associates
Los Angeles, California, United States, 90045
3
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States, 91786
4
David Fivenson, MD, Dermatology, PLLC
Ann Arbor, Michigan, United States, 48103