Brief Summary

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:

* How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment?
* How many participants have their skin disease activity go down by at least 70% as measured by CLASI?

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:

* After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine.
* Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks.
* The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
* This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin.
* During the 2nd treatment period, all participants will receive litifilimab for 28 weeks.
* After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks.
* The total study duration for participants will be up to 80 weeks.

Conditions

• Subacute Cutaneous Lupus Erythematosus
• Chronic Cutaneous Lupus Erythematosus

Intervention / Treatment

• Drug: Litifilimab
• Drug: Placebo

Primary Outcome Measures

• Parts A: Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1 (Week 16)
• Part B: Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline (Baseline to Week 24)

Countries

Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Hungary, Italy, Japan, Mexico, Peru, Philippines, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States

Locations and Investigators

• Cliniques Universitaires Saint-Luc, Sint-Lambrechts-Woluwe, Belgium
  • Pierre-Dominique, Ghislain
• UZ Leuven, Leuven, Belgium
  • Petra, De Haes
• Centre hospitalier universitaire de Liege, Liege, Belgium
  • Arjen, Nikkels
• Universitair Ziekenhuis Gent, Gent, Belgium
  • Reinhart, Speeckaert
• University Of Pecs, Pecs, Hungary
  • Anita, Hanyecz
• University Of Szeged, Szeged, Hungary
  • Rolland, Gyulai
• Semmelweis University, Budapest VIII, Hungary
  • Péter, Holló
• Diagnostic-Consultative Center Alexandrovska EOOD, Sofiya, Bulgaria
  • Petyo, Brezoev
• Specialized Hospital For Active Treatment In Cardiology EAD, Pleven, Bulgaria
  • Dimitar, Gospodinov
• Medical Center Medconsult Pleven OOD, Pleven, Bulgaria
  • Kamelia, Vekovska
• Dkc Fokus-5 Lzip OOD, Sofiya, Bulgaria
  • Grisha, Mateev
• Dcc 1 Sevlievo EOOD, Sevlievo, Bulgaria
  • Dimitar, Nikolov
• Dkc Fokus-5 Lzip OOD, Sofiya, Bulgaria
  • Rumen, Stoilov
• Military Medical Academy, Sofiya, Bulgaria
  • Boycho, Oparanov
• Dkc 1 Ruse EOOD, Ruse, Bulgaria
  • Nadezhda, Kapandjieva
• Diagnostics And Consultancy Center Sveti Georgi EOOD, Haskovo, Bulgaria
  • Irida, Vasileva
• ASMC IPSMC Skin And Venereal Diseases, Sofiya, Bulgaria
  • Ivan, Botev
• Diagnostic-Consultative Center Alexandrovska EOOD, Sofiya, Bulgaria
  • Snejina, Vassileva
• Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Warsaw, Poland
  • Lidia, Rudnicka
• Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p., Wroclaw, Poland
  • Jacek, Szepiatowski
• Dermoklinika-Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak, Łódź, Poland
  • Joanna, Narbutt
• Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SC, Krakow, Poland
  • Paweł, Brzewski
• Royalderm Agnieszka Nawrocka, Warszawa, Poland
  • Witold, Owczarek
• Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie, Rzeszow, Poland
  • Adam, Reich
• Promed P.Lach R.Glowacki Sp. j., Cracow, Poland
  • Ewa, Górecka
• MT Medic Specjalistyczna Praktyka Lekarska Tomas Stapiński, Krosno, Poland
  • Anna, Rajchel
• MICS Centrum Medyczne Warszawa, Warszawa, Poland
  • Katarzyna, Romanowska-Próchnicka
• Dermedic Jacek Zdybski, Kielce, Poland
  • Jacek, Zdybski
• Hospital Cuf Descobertas S.A., Lisbon, Portugal
  • Pedro, Mendes Bastos
• Unidade Local De Saude De Coimbra E.P.E., Coimbra, Portugal
  • Margarida, Gonçalo
• Unidade Local De Saude De Santo Antonio E.P.E., Porto, Portugal
  • Tiago, Torres
• Karolinska University Hospital, Solna, Sweden
  • Karin, Popovic Silwerfeldt
• Artromac N.O., Kosice, Slovakia
  • Zelmira, Macejova
• Narodny Ustav Reumatickych Chorob, Piestany, Slovakia
  • Olga, Lukacova
• Hospital Universitario Rio Hortega, Valladolid, Spain
  • Maria Julia, Barbado Ajo
• Hospital Universitario Puerta De Hierro De Majadahonda, Majadahonda, Spain
  • Rita, Cabeza Martínez
• Hospital Del Mar, Barcelona, Spain
  • Ramon Maria, Pujol Vallverdu
• Hospital General Universitario Reina Sofia, Cordoba, Spain
  • Juan Alberto, Ruano Ruiz
• University Hospital Virgen Del Rocio S.L., Sevilla, Spain
  • Enrique, Jorquera Barquero
• Hospital Germans Trias I Pujol, Badalona, Spain
  • Isabel, Bielsa Marsol
• Complexo Hospitalario Universitario A Coruna, A Coruna, Spain
  • Francisco Javier, Blanco García
• Hospital Universitari Vall D Hebron, Barcelona, Spain
  • Josefina, Cortes Hernandéz
• Hospital Universitario Fundacion Alcorcon, Madrid, Spain
  • Jose Luis, Lopez Estebaranz
• Hospital De La Santa Creu I Sant Pau, Barcelona, Spain
  • Esther, Roe Crespo
• Hospital General Universitario De Castellon, Castello De La Plana, Spain
  • Maria Arantzazu, Conesa Mateos
• Azienda Ospedaliera Universitaria Federico II Di Napoli, Naples, Italy
  • Paola, Nappa
• Ospedale San Raffaele S.r.l., Milan, Italy
  • Lorenzo, Dagna
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
  • Clara, De Simone
• IRCCS Ospedale Policlinico San Martino, Genoa, Italy
  • Emanuele Claudio, Cozzani
• University Of Florence, Florence, Italy
  • Marzia, Caproni

And 28 other sites.

Study Officials

• Medical Director (Study Director) — Biogen