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BIIB059 (litifilimab)
DRUG
3 trials
Sponsors
Biogen
Conditions
Active Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
Healthy Volunteers
Subacute Cutaneous Lupus Erythematosus
Systemic Lupus Erythematosus
Phase 1
Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 (Litifilimab) in Healthy Volunteers and Participants With Systemic Lupus Erythematosus
Completed
NCT02106897
Biogen
Healthy Volunteers, Systemic Lupus Erythematosus
Start: 2014-04-30
End: 2016-05-24
Updated: 2023-01-31
Phase 2
Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
Completed
NCT02847598
Biogen
Active Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus
Start: 2016-10-20
End: 2019-11-18
Updated: 2023-11-07
Phase 3
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
Enrolling by invitation
NCT06044337
Biogen
Chronic Cutaneous Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus
Start: 2023-10-03
End: 2029-12-11
Target: 306
Updated: 2026-08-04
Related Papers
All Subcomponents of the Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI-A) are Relevant to Identify and Detect Changes in Skin Activity
SKIN The Journal of Cutaneous Medicine
2026-03-10
ALL SUBCOMPONENTS OF THE CUTANEOUS LUPUS ERYTHEMATOSUS DISEASE AREA AND SEVERITY INDEX-ACTIVITY (CLASI-A) ARE RELEVANT TO IDENTIFY AND DETECT CHANGES IN SKIN ACTIVITY
The Journal of Rheumatology
2025-05-20
LP-184 Rationale and design of two phase 3, Randomized, double-blind, placebo-controlled studies of the efficacy and safety of litifilimab in adults with active systemic lupus erythematosus: TOPAZ-1 and TOPAZ-2
2023-07-01
Litifilimab (BIIB059), a promising investigational drug for cutaneous lupus erythematosus.
2023-05-15
7 citations
PO.4.75 The anti-BDCA2 antibody biib059 improves joint and skin manifestations in patients with SLE and both active arthritis and rash
2022-09-27
Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus Erythematosus
New England Journal of Medicine
2022-09-07
109 citations
Trial of Anti-BDCA2 Antibody Litifilimab for Cutaneous Lupus Erythematosus
New England Journal of Medicine
2022-07-27
119 citations
A clinical population pharmacokinetic/pharmacodynamic model for BIIB059, a monoclonal antibody for the treatment of systemic and cutaneous lupus erythematosus.
2020-04-25
6 citations
Monoclonal antibody targeting BDCA2 ameliorates skin lesions in systemic lupus erythematosus.
2019-02-18
195 citations