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A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Sponsor: Biogen
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2022-09-13
Completion Date
2027-12-14
Last Updated
2026-10-23
Healthy Volunteers
No
Interventions
Litifilimab
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Locations (315)
Pinnacle Research Group, LLC
Anniston, Alabama, United States
UAB Center for Women's Reproductive Health
Birmingham, Alabama, United States
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States
The Regents of the University of California
La Jolla, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Clinical Science Institute
Santa Monica, California, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Omega Research Debary, LLC
DeBary, Florida, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States
University of Florida
Gainesville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Millennium Medical Research, LLC
Miami, Florida, United States
Medical Research Center of Miami
Miami, Florida, United States
Diverse Clinical Research LLC
Miami, Florida, United States
Charisma Medical and Research Center
Miami Lakes, Florida, United States
Leading Edge Dermatology
Plantation, Florida, United States
Augusta University
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
OrthoIllinois
Rockford, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Equity Medical
Bowling Green, Kentucky, United States
LSU Health Sciences Center Shreveport
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham And Women's Hospital
Boston, Massachusetts, United States
Essential Dermatology
Natick, Massachusetts, United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, United States
University of Massachusetts, Worcester
Worcester, Massachusetts, United States
David Fivenson, MD, Dermatology, PLLC
Ann Arbor, Michigan, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
AA MRC LLC Ahmed Arif Medical Research Center
Flint, Michigan, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Saint Louis University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, United States
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States
NYU Langone Brooklyn
Brooklyn, New York, United States
Universal Dermatology, PLLC
Fairport, New York, United States
Northwell Health, Inc. PRIME
Great Neck, New York, United States
Columbia University Medical center
New York, New York, United States
Hawthorne Health
Staten Island, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke Dermatology South Durham
Durham, North Carolina, United States
Medication Management, LLC
Greensboro, North Carolina, United States
University of Cincinnati Department of Dermatology
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Austin Regional Clinic, P.A.
Austin, Texas, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, United States
Metroplex Clinical Research Center, LLC
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
North Texas Center for Clinical Research
Frisco, Texas, United States
UTMB Department of Dermatology
Galveston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Arthritis & Osteoporosis Clinic
Waco, Texas, United States
Velocity Clinical Research Waco
Waco, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Open Door Clinical Research
Blacksburg, Virginia, United States
West End Dermatology Associates
Richmond, Virginia, United States
CINME - Centro De Investigaciones Metabolicas
CABA, Buenos Aires, Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires, Argentina
Centro de Investigaciones San Miguel
San Miguel, Buenos Aires, Argentina
APRILLUS Asistencia e Investigacion
Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Fundacion Respirar
Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Consultorio Alto Dorrego
Villa Nueva, Mendoza Province, Argentina
Instituto CAICI
Rosario, Santa Fe Province, Argentina
Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
San Miguel de Tucumán, Tucumán Province, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, Argentina
Investigaciones Clinicas Tucuman
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital Italiano de La Plata
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Centro Privado de Medicina Familiar - Mind Out Research
Ciudad Autonoma Buenos Aires, Argentina
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, Argentina
Instituto de Reumatologia
Mendoza, Argentina
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan, Argentina
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Centre Hospitalier Universitaire de Liege
Liège, Belgium
Integrare Terapêutica
Fortaleza, Ceará, Brazil
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, Ceará, Brazil
CEDOES - Diagnóstico e Pesquisa
Vitória, Espírito Santo, Brazil
Clínica SER da Bahia
Salvador, Estado de Bahia, Brazil
L2IP - Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Santo Ângelo, Mato Grosso, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Freire Pesquisa Clinica
Belo Horizonte, Minas Gerais, Brazil
Clinica Pulsus
Belo Horizonte, Minas Gerais, Brazil
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, Brazil
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
Rio de Janeiro, Rio Do Janeiro, Brazil
IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda
Rio de Janeiro, Rio Do Janeiro, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
LMK Serviços Médicos S/S Ltda
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil