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litifilimab   Click here for help

GtoPdb Ligand ID: 11122

Synonyms: BIIB-059 | BIIB059
Immunopharmacology Ligand
Compound class: Antibody
Comment: Litifilimab (BIIB059) is a fully humanized IgG1, CLEC4C (blood dendritic cell antigen 2, BDCA2) targeting monoclonal antibody. It is being evaluated for ability to reduce release of disease-driving interferons (principally IFN-α) in SLE/CLE. BIIB059 was developed by Biogen, based on prior evidence of target engagement and SLE-applicable immunomodulatory efficacy of a humanized mAb against BDCA2 named 24F4A [8].
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Summary of Clinical Use Click here for help
Litifilimab (BIIB059) was progressed to clinical evaluations as a monotherapy in patients with systemic lupus erythematosus (SLE) [7] and active cutaneous lupus erythematosus (CLE) [1,3,9].
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT03224793 Safety, Tolerability, and Pharmacokinetics of Single Doses of BIIB059 in Healthy Japanese Subjects. Phase 1 Interventional Biogen
NCT02106897 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 in Healthy Volunteers and Participants With Systemic Lupus Erythematosus Phase 1 Interventional Biogen This study is known as the 'LILAC' trial. Results suggest that targeting pDCs has efficacy in patients with SLE, especially in patients with cutaneous manifestations for whom it reduced skin lesions. 4
NCT04895241 A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus Phase 3 Interventional Biogen
NCT04961567 A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus Phase 3 Interventional Biogen
NCT05352919 An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus Phase 3 Interventional Biogen
NCT06044337 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 Phase 3 Interventional Biogen
NCT02847598 Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE) Phase 2 Interventional Biogen Compared to placebo and pre-treatment disease scores, litifilimab treatment was associated with decreased skin disease activity in CLE, and a reduction in the number of swollen and tender joints in SLE. 5-6,10-11