Synonyms: BIIB-059 | BIIB059
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 [3].
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No information available. |
Summary of Clinical Use |
BIIB059 has progressed to Phase 2 clinical evaluation as a monotherapy in patients with SLE and active CLE. |
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. | 1 |
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. | 2,4 |