A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.
The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms and signs of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).
The main questions researchers want to answer are:
Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires.
The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows:
Litifilimab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting blood dendritic cell antigen 2. It is an inhibitory receptor expressed on the surface of human plasmacytoid dendritic cell (pDCs) and is being investigated for the potential treatment of systemic lupus erythematosus and cutaneous lupus erythematosus. The primary objectives of the study are to evaluate the efficacy of litifilimab compared with placebo in reducing skin disease activity measured by the CLA-IGA-R score [Parts A] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of litifilimab in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of litifilimab in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of litifilimab [Parts A and B].
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply
CABA, Buenos Aires C1056ABI, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
San Miguel de Tucumán, Tucumán Province T4000AXL, Argentina
Ciudad Autonoma Buenos Aires, C1199ABB, Argentina
Ciudad Autonoma Buenos Aires, C1417, Argentina
Ciudad Autonoma Buenos Aires, C1430EGF, Argentina
Fortaleza, Ceará 60430-370, Brazil
Santo Ângelo, Mato Grosso 78020-500, Brazil
Rio de Janeiro, Rio Do Janeiro 22470-220, Brazil
São Bernardo do Campo, São Paulo 09715-090, Brazil
São Paulo, São Paulo 04266-010, Brazil
Chongqing, Chongqing Municipality 400016, China
Shanghai, Shanghai Municipality 200011, China
Hangzhou, Zhejiang 310003, China
Bogotá, 110221, Colombia
Cedex 10, Paris 75475, France
Brescia, 25123, Italy
Toyoake-shi, Aichi-ken 470-1192, Japan
Urayasu-shi, Chiba 279-0021, Japan
Yoshida-gun, Fukui 910-1193, Japan
Kitakyushu-shi, Fukuoka 807-8556, Japan
Kakogawa-shi, Hyōgo 675-8611, Japan
Ono-shi, Hyōgo 675-1392, Japan
Kawasaki-shi, Kanagawa 216-8511, Japan
Kawachinagano-shi, Osaka 586-8521, Japan
Osakasayama-shi, Osaka 589-8511, Japan
Suita-shi, Osaka 565-0871, Japan
Takatsuki-shi, Osaka 569-1096, Japan
Izumo-shi, Shimane 693-8501, Japan
Itabashi-ku, Tokyo-To 173-8606, Japan
Shinagawa-ku, Tokyo-To 142-0054, Japan
Quezon City, Metro Manila, 1118, Philippines
San Fenando, La Union, 2500, Philippines
San Fernando City, La Union, 2500, Philippines
Valladolid, Cantabria 47012, Spain
Zurich-Flughafen, Canton of Zurich 8058, Switzerland
Ivano-Frankivsk, 76018, Ukraine
Lviv, 79010, Ukraine
Poltava, 36011, Ukraine
Ternopil, 46002, Ukraine