Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

Summary

The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement (Part A), and in participants with active cutaneous lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE, including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of BIIB059 (Parts A and B).

Timeline

Start

2016-10-20

Primary completion

2019-08-28

Completion

2019-11-18

Outcome

Met primary endpoint

registry Part A: Placebo vs Part A: BIIB059 450 mg; p = 0.037; Least squares (LS) mean Difference -3.4 (95% CI -6.7 to -0.2) NCT02847598 ↗

registry Part B: Placebo vs Part B: BIIB059 150 mg; p <0.001; LS mean difference -33.42 (95% CI -52.71 to -14.12) NCT02847598 ↗

release “The Phase 2 LILAC study met its primary endpoints, demonstrating statistically significant reduction of disease activity in patients with CLE and SLE” biogen.com ↗

Publications

• Cho SK, Vazquez T, Werth VP. Litifilimab (BIIB059), a promising investigational drug for cutaneous lupus erythematosus. Expert Opin Investig Drugs. 2023 May;32(5):345-353. doi: 10.1080/13543784.2023.2212154. Epub 2023 May 15.
• Furie RA, van Vollenhoven RF, Kalunian K, Navarra S, Romero-Diaz J, Werth VP, Huang X, Clark G, Carroll H, Meyers A, Musselli C, Barbey C, Franchimont N; LILAC Trial Investigators. Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus Erythematosus. N Engl J Med. 2022 Sep 8;387(10):894-904. doi: 10.1056/NEJMoa2118025.
• Werth VP, Furie RA, Romero-Diaz J, Navarra S, Kalunian K, van Vollenhoven RF, Nyberg F, Kaffenberger BH, Sheikh SZ, Radunovic G, Huang X, Clark G, Carroll H, Naik H, Gaudreault F, Meyers A, Barbey C, Musselli C, Franchimont N; LILAC Trial Investigators. Trial of Anti-BDCA2 Antibody Litifilimab for Cutaneous Lupus Erythematosus. N Engl J Med. 2022 Jul 28;387(4):321-331. doi: 10.1056/NEJMoa2118024.
• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
• Hartmann S, Biliouris K, Naik H, Rabah D, Stevenson L, Shen C, Nestorov IA, Lesko LJ, Trame MN. A clinical population pharmacokinetic/pharmacodynamic model for BIIB059, a monoclonal antibody for the treatment of systemic and cutaneous lupus erythematosus. J Pharmacokinet Pharmacodyn. 2020 Jun;47(3):255-266. doi: 10.1007/s10928-020-09688-y. Epub 2020 Apr 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Litifilimab	Monoclonal antibody	50 mg	Subcutaneous
Subject	Litifilimab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Litifilimab	Monoclonal antibody	450 mg	Subcutaneous

Indications