A Study to Assess the Efficacy and Safety of BIIB059 (Litifilimab) in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
About this trial
This is an interventional treatment trial for Subacute Cutaneous Lupus Erythematosus focused on measuring Cutaneous Lupus Erythematosus (CLE), Acute Cutaneous Lupus Erythematosus (ACLE), Discoid Lupus Erythematosus (DLE), Systemic Lupus Erythematosus (SLE), Lupus
Eligibility Criteria
Key Inclusion Criteria:
- Histologically confirmed (in the past or at Screening) diagnosis of CLE with or without systemic manifestations.
- Must have active cutaneous manifestations that meet study criteria.
- Must have a CLASI-A score ≥10.
- Must have an active CLE lesion despite an adequate trial of antimalarial treatment.
Key Exclusion Criteria:
- Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
- Active severe lupus nephritis.
- Active neuropsychiatric SLE.
- Use of immunosuppressive or disease-modifying treatments for SLE or CLE [via an oral, intravenous (IV), or SC route] that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Sites / Locations
- Pinnacle Research Group, LLCRecruiting
- UAB Center for Women's Reproductive HealthRecruiting
- Arizona Arthritis & Rheumatology Research, PLLCRecruiting
- Dermatology Research AssociatesRecruiting
- Clinical Science InstituteRecruiting
- Inland Rheumatology Clinical Trials, Inc.Recruiting
- Denver Arthritis ClinicRecruiting
- Omega Research Debary, LLCRecruiting
- Centre for Rheumatology, Immunology and ArthritisRecruiting
- University of FloridaRecruiting
- Charisma Medical and Research CenterRecruiting
- University of Miami Miller School of MedicineRecruiting
- Medical Research Center of Miami
- OrthoIllinoisRecruiting
- Dawes Fretzin Dermatology Group, LLCRecruiting
- Brigham And Women's HospitalRecruiting
- Essential DermatologyRecruiting
- Beacon Clinical Research, LLCRecruiting
- University of Massachusetts, WorcesterRecruiting
- David Fivenson, MD, Dermatology, PLLCRecruiting
- Oakland Hills DermatologyRecruiting
- AA MRC LLC Ahmed Arif Medical Research CenterRecruiting
- Revival Research Institute, LLCRecruiting
- Saint Louis UniversityRecruiting
- University of Nebraska Medical CenterRecruiting
- Albuquerque Center For RheumatologyRecruiting
- University of New Mexico School of MedicineRecruiting
- NYU Langone BrooklynRecruiting
- Universal Dermatology, PLLCRecruiting
- Northwell Health, Inc. PRIMERecruiting
- University of North Carolina at Chapel HillRecruiting
- Duke Dermatology South DurhamRecruiting
- Medication Management, LLC
- University of Cincinnati Department of DermatologyRecruiting
- University Hospitals Cleveland Medical CenterRecruiting
- Ohio State UniversityRecruiting
- Penn State University Milton S. Hershey Medical CenterRecruiting
- University of PennsylvaniaRecruiting
- Vanderbilt University Medical CenterRecruiting
- Austin Regional Clinic, P.A.Recruiting
- Precision Comprehensive Clinical Research SolutionsRecruiting
- Metroplex Clinical Research Center, LLCRecruiting
- UT Southwestern Medical CenterRecruiting
- North Texas Center for Clinical ResearchRecruiting
- UTMB Department of DermatologyRecruiting
- Arthritis & Osteoporosis ClinicRecruiting
- University of Utah Health Sciences CenterRecruiting
- West End Dermatology AssociatesRecruiting
- CINME - Centro De Investigaciones MetabolicasRecruiting
- Centro de Investigaciones Medicas Mar del PlataRecruiting
- Instituto de Investigaciones Clinicas QuilmesRecruiting
- APRILLUS Asistencia e InvestigacionRecruiting
- Fundacion RespirarRecruiting
- Clinica Mayo de Urgencias Medicas Cruz Blanca SRLRecruiting
- Centro de Investigaciones Medicas TucumanRecruiting
- Investigaciones Clinicas TucumanRecruiting
- Hospital Italiano de La PlataRecruiting
- Centro Privado de Medicina Familiar - Mind Out ResearchRecruiting
- Clinica Adventista BelgranoRecruiting
- Instituto de ReumatologiaRecruiting
- HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do CearáRecruiting
- L2IP - Instituto de Pesquisas Clínicas Ltda.Recruiting
- CEDOES - Diagnóstico e PesquisaRecruiting
- Instituto Brasil de Pesquisa Clínica-IBPCLIN S/ARecruiting
- Hospital Bruno BornRecruiting
- Nucleo de Pesquisa Clinica do Rio Grande do SulRecruiting
- CEMEC - Centro Multidisciplinar de Estudos ClínicosRecruiting
- CEPIC - Centro Paulista de Investigação Clínica e Serviços MédicosRecruiting
- Medical center Medconsult Pleven OODRecruiting
- UMHAT 'Dr. Georgi Stranski', EADRecruiting
- DCC 1 - Ruse, EOODRecruiting
- DCC 'Alexandrovska', EOODRecruiting
- DCC Focus 5 - MEOH OODRecruiting
- DCC Focus 5 - MEOH OODRecruiting
- Military Medical Academy - MHAT - SofiaRecruiting
- Dermatology Clinic of Dr. Michael RobernRecruiting
- Medicor Research IncRecruiting
- DIEX Recherche Sherbrooke Inc.Recruiting
- DermacrossRecruiting
- BioMedica Research GroupRecruiting
- CIEC - Centro Internacional de Estudios ClínicosRecruiting
- Clinical Research Chile SpA.Recruiting
- Oncocentro APYSRecruiting
- CHU Nice - Hopital de l ArchetRecruiting
- Hôpital de la TimoneRecruiting
- CHU de Caen - Hopital de la Cote de NacreRecruiting
- CHU Besançon - Hôpital Jean MinjozRecruiting
- Hopital LarreyRecruiting
- Hôpital Privé d'AntonyRecruiting
- Hopital Saint EloiRecruiting
- Hôpital Saint-LouisRecruiting
- Hopital Edouard Herriot - CHU LyonRecruiting
- Hopital TenonRecruiting
- Universitaetsklinikum ErlangenRecruiting
- Fachklinik Bad Bentheim DermatologieRecruiting
- Elbekliniken Buxtehude GmbHRecruiting
- Klinikum Oldenburg AoeRRecruiting
- Universitaetsklinikum MuensterRecruiting
- Universitaetsklinikum Halle (Saale)Recruiting
- Universitaetsklinikum Carl Gustav Carus TU DresdenRecruiting
- Universitaetsklinikum Schleswig-Holstein - Campus KielRecruiting
- Charité - Campus Charité MitteRecruiting
- Pecsi TudomanyegyetemRecruiting
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCSRecruiting
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)Recruiting
- Università degli studi di FirenzeRecruiting
- IRCCS Ospedale Policlinico San MartinoRecruiting
- Fondazione IRCCS CA' Granda Ospedale Maggiore PoliclinicoRecruiting
- Polyclinic Federico IIRecruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
- University of Fukui HospitalRecruiting
- Kita Harima Medical CenterRecruiting
- Niigata University Medical & Dental HospitalRecruiting
- Korea University Ansan HospitalRecruiting
- Ajou University HospitalRecruiting
- Chonnam National University HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Hanyang University Seoul HospitalRecruiting
- The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
- Clinstile, S.A. de C.V.Recruiting
- Centro de Investigacion Clínica GRAMEL S.CRecruiting
- Consultorio Privado Dr. Miguel Cortes HernandezRecruiting
- Medical Care & Research SA de CVRecruiting
- Investigacion y Biomedicina de Chihuahua, S.C.Recruiting
- Cebu Doctors University HospitalRecruiting
- Mary Mediatrix Medical CenterRecruiting
- St. Luke's Medical CenterRecruiting
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek BrzewskiRecruiting
- SPZOZ Szpital Uniwersytecki w KrakowieRecruiting
- Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A LesiakRecruiting
- Kliniczny Szpital Wojewodzki nr 1 im.F.ChopinaRecruiting
- RoyaldermRecruiting
- Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka PartnerskaRecruiting
- Hospital de Egas MonizRecruiting
- Hospital CUF DescobertasRecruiting
- Centro Hospitalar Universitártio do Porto, E.P.E.Recruiting
- Unidade Local de Saúde do Alto Minho, E.P.E.Recruiting
- Dr. Samuel Sanchez PSCRecruiting
- GCM Medical Group PSC - Hato ReyRecruiting
- Institute of RheumatologyRecruiting
- University Clinical Center of SerbiaRecruiting
- Artromac n.o.Recruiting
- Narodny ustav reumatickych chorobRecruiting
- Hospital Universitari Germans Trias i PujolRecruiting
- Hospital Universitario Rio HortegaRecruiting
- Hospital Universitario Fundacion AlcorconRecruiting
- Hospital Universitario Puerta de Hierro MajadahondaRecruiting
- Hospital del MarRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Hospital Universitario Reina SofiaRecruiting
- Complejo Hospitalario Universitario A CoruñaRecruiting
- Hospital Universitario Virgen del RocioRecruiting
- Karolinska Universitetssjukhuset - SolnaRecruiting
- Centre Hospitalier Universitaire Vaudois (CHUV)Recruiting
- Kantonsspital St. GallenRecruiting
- Changhua Christian Medical Foundation Changhua Christian HospitalRecruiting
- Kaohsiung Chang Gung Memorial HospitalRecruiting
- Taichung Veterans General HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- Whipps Cross University HospitalRecruiting
- Manchester Royal InfirmaryRecruiting
- Queen Elizabeth HospitalRecruiting
- Chapel Allerton HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Part A (Phase 2): BIIB059
Part A (Phase 2): Placebo
Part B (Phase 3): BIIB059
Part B (Phase 3): Placebo
Participants will receive BIIB059 subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of BIIB059 at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of BIIB059-matching placebo at Week 26.
Participants will receive BIIB059-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of BIIB59-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059 at Week 26.
Participants will receive BIIB059 SC Q4W from Week 0 to Week 20, with an additional dose of BIIB059 at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059-matching placebo at Week 26.
Participants will receive BIIB059-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of BIIB59-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive BIIB059 during the ETP from Week 24 to Week 48, with an additional dose of BIIB059 at Week 26.