AzTrials
AzTrials

Subacute Cutaneous Lupus ErythematosusPhase 2/3AMETHYSTNCT05531565

A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

A Phase 2/3 study testing Litifilimab in people with Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus, run by Biogen at 315 sites in 30 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Litifilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
315 sitesin 30 countries
Study dates
13 Sep 2022to 14 Dec 2027
Phase
Phase 2/3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed (in the past or during the Screening period) 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.

Who cannot join

  • Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
  • Diagnosis of mixed connective tissue disease [(within 1 year of signing the informed consent form (ICF)] or any history of overlap syndromes of SLE including concomitant presence with rheumatoid arthritis, dermatomyositis and/or polymyositis, systemic sclerosis, psoriatic arthritis, or any other autoimmune disease that may confound the evaluation of the disease activity or the effect of the investigational product. Exceptions for overlap syndrome of SLE include participants with overlap syndrome of SLE with myositis and secondary Sjögren's syndrome at screening is permitted provided the participant also meets the criteria for classification as SLE. A past history of mixed connective tissue disease that over time has developed into a diagnosis of SLE is permitted, provided diagnosis of SLE has been present for at least 1 year.
  • Active severe lupus nephritis.
  • Active neuropsychiatric SLE.
  • Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
  • 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 screening, have not been at a stable and allowable dose.
  • NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

315 sites in 30 countries.

315 sites in 30 countries

United States62 sites

  • Albuquerque Center For Rheumatology

    Albuquerque, New Mexico, 87102

  • University of New Mexico School of Medicine

    Albuquerque, New Mexico, 87106

  • David Fivenson, MD, Dermatology, PLLC

    Ann Arbor, Michigan, 48103

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • Oakland Hills Dermatology

    Auburn Hills, Michigan, 48326

  • Augusta University

    Augusta, Georgia, 30912

  • Austin Regional Clinic, P.A.

    Austin, Texas, 78731

  • UAB Center for Women's Reproductive Health

    Birmingham, Alabama, 35233-7340

  • Open Door Clinical Research

    Blacksburg, Virginia, 24060

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Brigham And Women's Hospital

    Boston, Massachusetts, 02115

  • Equity Medical

    Bowling Green, Kentucky, 42104

  • NYU Langone Brooklyn

    Brooklyn, New York, 11220

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati Department of Dermatology

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034

  • Ohio State University

    Columbus, Ohio, 43210

  • Metroplex Clinical Research Center, LLC

    Dallas, Texas, 75231

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-8896

  • Omega Research Debary, LLC

    DeBary, Florida, 32713

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • Duke Dermatology South Durham

    Durham, North Carolina, 27710

  • Universal Dermatology, PLLC

    Fairport, New York, 14450

  • AA MRC LLC Ahmed Arif Medical Research Center

    Flint, Michigan, 48504

  • Centre for Rheumatology, Immunology and Arthritis

    Fort Lauderdale, Florida, 33334

  • North Texas Center for Clinical Research

    Frisco, Texas, 75034

  • University of Florida

    Gainesville, Florida, 32610

  • UTMB Department of Dermatology

    Galveston, Texas, 77555-0583

  • Northwell Health, Inc. PRIME

    Great Neck, New York, 11021

  • Medication Management, LLC

    Greensboro, North Carolina, 27405

  • Penn State University Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77054

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • The Regents of the University of California

    La Jolla, California, 92037

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • University of Miami Miller School of Medicine

    Miami, Florida, 33125

  • Millennium Medical Research, LLC

    Miami, Florida, 33126

  • Medical Research Center of Miami

    Miami, Florida, 33134

  • Diverse Clinical Research LLC

    Miami, Florida, 33175

  • Charisma Medical and Research Center

    Miami Lakes, Florida, 33014

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Essential Dermatology

    Natick, Massachusetts, 01760

  • LSU Health Sciences Center Shreveport

    New Orleans, Louisiana, 70112

  • Columbia University Medical center

    New York, New York, 10032

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona, 85032

  • Leading Edge Dermatology

    Plantation, Florida, 33317

  • Beacon Clinical Research, LLC

    Quincy, Massachusetts, 02169

  • West End Dermatology Associates

    Richmond, Virginia, 23233

  • OrthoIllinois

    Rockford, Illinois, 61114

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Saint Louis University

    St Louis, Missouri, 63110

  • Hawthorne Health

    Staten Island, New York, 10309

  • Revival Research Institute, LLC

    Troy, Michigan, 48084

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786

  • Arthritis & Osteoporosis Clinic

    Waco, Texas, 76710

  • Velocity Clinical Research Waco

    Waco, Texas, 76710

  • University of Massachusetts, Worcester

    Worcester, Massachusetts, 01655

Other trials in United States

Japan30 sites

  • Aomori Prefectural Central Hospital

    Aomori, Aomori, 030-8553

  • Teikyo University Hospital

    Itabashi-ku, Tokyo-To, 173-8606

  • Shimane University Hospital

    Izumo-shi, Shimane, 693-8501

  • Kakogawa Central City Hospital

    Kakogawa-shi, Hyōgo, 675-8611

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • NHO Osaka Minami Medical Center

    Kawachinagano-shi, Osaka, 586-8521

  • St. Marianna University Hospital

    Kawasaki-shi, Kanagawa, 216-8511

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, Fukuoka, 807-8556

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • JCHO Chukyo Hospital

    Nagoya, Aichi-ken, 457-8510

  • NHO Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata, 951-8520

  • Japanese Red Cross Okayama Hospital

    Okayama, Okayama-ken, 700-8607

  • Kita Harima Medical Center

    Ono-shi, Hyōgo, 675-1392

  • Osaka Keisatsu Hospital

    Osaka, Osaka, 543-8922

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Showa University East Hospital

    Shinagawa-ku, Tokyo-To, 142-0054

  • Osaka University Hospital

    Suita-shi, Osaka, 565-0871

  • Takatsuki Red Cross Hospital

    Takatsuki-shi, Osaka, 569-1096

  • Fujita Health University Hospital

    Toyoake-shi, Aichi-ken, 470-1192

  • Juntendo University Urayasu Hospital

    Urayasu-shi, Chiba, 279-0021

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

  • NHO Yokohama Medical Center

    Yokohama, Kanagawa, 245-8575

  • University of Fukui Hospital

    Yoshida-gun, Fukui, 910-1193

Other trials in Japan

China26 sites

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 014010

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Xiangya Hospital of Central South University

    Changsha, Hu'nan, 410008

  • The second Xiangya Hospital of Central South University

    Changsha, Hu'nan, 410011

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523059

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangzhou, 510120

  • The First Affiliated Hospital of Zhejiang University school of medicine

    Hangzhou, Zhejiang, 310003

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310006

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650101

  • Hospital for Skin Diseases, Chinese Academy of Medical Sciences

    Nanjing, Jiangsu, 210042

  • Nanyang First People's Hospital

    Nanyang, Henan, 473004

  • Ruijin Hospital of Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200011

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality, 200443

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518029

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

  • Zhongshan TCM Hospital

    Zhongshan, Guangdong, 528400

Other trials in China

Brazil22 sites

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

  • Freire Pesquisa Clinica

    Belo Horizonte, Minas Gerais, 30150-320

  • Clinica Pulsus

    Belo Horizonte, Minas Gerais, 30180-065

  • L2IP - Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730

  • Integrare Terapêutica

    Fortaleza, Ceará, 60125-000

  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

    Fortaleza, Ceará, 60430-370

  • CMiP - Centro Mineiro de Pesquisa

    Juiz de Fora, Minas Gerais, 36010-570

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-000

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Nucleo de Pesquisa Clinica do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90430001

  • LMK Serviços Médicos S/S Ltda

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90560032

  • IPES - Instituto de Pesquisa e Educação em Saúde

    Porto Velho, Rondônia, 76804366

  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

    Rio de Janeiro, Rio Do Janeiro, 20241-180

  • IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda

    Rio de Janeiro, Rio Do Janeiro, 22470-220

  • Clínica SER da Bahia

    Salvador, Estado de Bahia, 40150-150

  • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

    Santo Ângelo, Mato Grosso, 78020-500

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, São Paulo, 09715-090

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

    São Paulo, São Paulo, 04266-010

  • RDSS Ricardo Diaz Scientific Solution

    São Paulo, 04037-030

  • A2Z Clinical Centro Avancado de Pesquisa Clinica

    Valinhos, São Paulo, 13271-130

  • CEDOES - Diagnóstico e Pesquisa

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Germany18 sites

  • Universitaetsklinikum Aachen AoeR

    Aachen, North Rhine-Westphalia, 52074

  • Fachklinik Bad Bentheim Dermatologie

    Bad Bentheim, Lower Saxony, 48455

  • Charité - Campus Charité Mitte

    Berlin, 10117

  • Universitaetsklinikum Bonn AoeR

    Bonn, North Rhine-Westphalia, 53127

  • Elbekliniken Buxtehude GmbH

    Buxtehude, Lower Saxony, 21614

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, Saxony, 1307

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Halle (Saale)

    Halle, Saxony-Anhalt, 6120

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • LMU-Campus Innenstadt

    Munich, Bavaria, 80336

  • Klinikum rechts der Isar der TU Muenchen

    Munich, Bavaria, 80802

  • Universitaetsklinikum Muenster

    Münster, North Rhine-Westphalia, 48149

  • Klinikum Oldenburg AoeR

    Oldenburg, Lower Saxony, 26133

  • Universitaetsklinikum Regensburg

    Regensburg, Bavaria, 93053

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Wuerzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

Argentina17 sites

  • APRILLUS Asistencia e Investigacion

    Buenos Aires, Ciudad Autonoma Buenos Aires, C1406AGA

  • Fundacion Respirar

    Buenos Aires, Ciudad Autonoma Buenos Aires, C1426ABO

  • Hospital Italiano de La Plata

    Buenos Aires, B1900AXI

  • CINME - Centro De Investigaciones Metabolicas

    CABA, Buenos Aires, C1056ABI

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1199ABB

  • Centro Privado de Medicina Familiar - Mind Out Research

    Ciudad Autonoma Buenos Aires, C1417

  • Clinica Adventista Belgrano

    Ciudad Autonoma Buenos Aires, C1430EGF

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, 7600

  • Instituto de Reumatologia

    Mendoza, M5500

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires, B1878GEG

  • Instituto CAICI

    Rosario, Santa Fe Province, S2000PBJ

  • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

    San Juan, 5400

  • Centro de Investigaciones San Miguel

    San Miguel, Buenos Aires, 1663

  • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

    San Miguel de Tucumán, Tucumán Province, 4000

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000AXL

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000ICL

  • Consultorio Alto Dorrego

    Villa Nueva, Mendoza Province, CP 5519

Other trials in Argentina

Philippines12 sites

  • Cebu Doctors University Hospital

    Cebu City, 6000

  • Ospital Ng Makati

    City of Taguig, 1642

  • Mary Mediatrix Medical Center

    Lipa City, 4217

  • The Medical City Clark

    Mabalacat, Pampanga, 2023

  • Medical Center Manila

    Manila, 1000

  • Philippine General Hospital

    Manila, 1000

  • Jose R. Reyes Memorial Medical Center

    Manila, 1012

  • The Medical City

    Pasig, 1605

  • St. Luke's Medical Center

    Quezon City, 1102

  • Far Eastern University - Dr. Nicanor Reyes Medical Foundation

    Quezon City, Metro Manila, 1118

  • Ilocos Training and Regional Medical Center

    San Fenando, La Union, 2500

  • Lorma Medical Center

    San Fernando City, La Union, 2500

Other trials in Philippines

France11 sites

  • Hôpital Privé d'Antony

    Antony, Hauts De Seine, 92160

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, Doubs, 25030

  • CHU de Caen - Hopital de la Cote de Nacre

    Caen, Calvados, 14033

  • Hôpital Saint-Louis

    Cedex 10, Paris, 75475

  • Hopital Claude Huriez - CHU Lille

    Lille, Nord, 59037

  • Hopital Edouard Herriot - CHU Lyon

    Lyon, Rhone, 69003

  • Hôpital de la Timone

    Marseille, Bouches-du-Rhône, 13385

  • Hopital Saint Eloi

    Montpellier, Herault, 34295

  • CHU Nice - Hopital de l Archet

    Nice, Alpes Maritimes, 6200

  • Hopital Tenon

    Paris, 75020

  • Hopital Larrey

    Toulouse, Haute Garonne, 31059

Other trials in France

Poland11 sites

  • DERMEDIC Jacek Zdybski

    Kielce, 25-553

  • SPZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • Promed P.Lach R.Glowacki spolka jawna, Centrum Medyczne PROMED

    Krakow, 31-513

  • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski

    Krakow, 31-530

  • MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapinski

    Krosno, 38-400

  • Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A Lesiak

    Lodz, 90-436

  • Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina

    Rzeszów, 35-055

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874

  • Szpital Kliniczny Dzieciatka Jezus

    Warsaw, 02-008

  • Royalderm, Agnieszka Nawrocka

    Warsaw, 02-962

  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, 50-566

Other trials in Poland

Spain11 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Madrid, 28922

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 8916

  • Hospital Universitari Vall d'Hebron - VHIR

    Barcelona, 08035

  • Hospital del Mar

    Barcelona, 8003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital General de Castellon

    Castellon, Castellón, 12004

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Rio Hortega

    Valladolid, Cantabria, 47012

Other trials in Spain

Ukraine11 sites

  • CNE Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009

  • CNCE Regional Clinical Hospital of Ivano-Frankivsk Regional Council, Dept of Rheumatology

    Ivano-Frankivsk, 76018

  • Medical Center Artes Medicum LLC

    Kyiv, 02002

  • Med Center 'Ok!Clinic+' LLC "International Institute of Clinical Research"

    Kyiv, 02091

  • Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council

    Lutsk, 43005

  • Lviv Regional Clinical Hospital

    Lviv, 79010

  • Communal Enterprise M.V.Sklifosovskyi Poltava Regional Clinical Hospital of Poltava Regional Council

    Poltava, 36011

  • CNE Ternopil Reg Clinical Hospital TRC, Dept of Rheumatology, SHEI I.Ya.HorbachevskyiTernopil SMU

    Ternopil, 46002

  • ZAKARPATTIA ENDOCLINIC LLC, Medical Center Endoclinic

    Uzhhorod, 88000

  • Private Small Enterprise Medical Center Pulse

    Vinnytsia, 21001

  • СNE M.I. Pyrogov RCH of Vinnytsia RC HSC Reum Osteo Bio Th

    Vinnytsia, 21018

Other trials in Ukraine

Bulgaria9 sites

  • DCC 'Sveti Georgi' EOOD

    Haskovo, 6300

  • Medical center Medconsult Pleven OOD

    Pleven, 5800

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

  • DCC 1 - Ruse, EOOD

    Rousse, 7002

  • DCC-1-Sevlievo EOOD

    Sevlievo, Gabrovo, 5400

  • Ambulatory for Specialized Medical Help - skin and venereal diseases

    Sofia, 1407

  • DCC 'Alexandrovska', EOOD

    Sofia, 1431

  • DCC Focus 5 - MEOH OOD

    Sofia, 1463

  • Military Medical Academy - MHAT - Sofia

    Sofia, 1606

Other trials in Bulgaria

Italy8 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna, 40138

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, 25123

  • Università degli studi di Firenze

    Florence, 50121

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliera Universitaria Policlinico 'Federico II'

    Naples, 80131

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 137

Other trials in Italy

Chile7 sites

  • Centro Medico SkinMed

    Las Condes, 7580206

  • Dermacross

    Santiago, 66901

  • BioMedica Research Group

    Santiago, 7500710

  • CeCim Biocinetic

    Santiago, 8331143

  • CIEC - Centro Internacional de Estudios Clínicos

    Santiago, 8420383

  • Clinical Research Chile SpA.

    Valdivia, 5090000

  • Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas

    Viña del Mar, 2520598

Other trials in Chile

Mexico7 sites

  • Derma Norte del Bajio S.C.

    Aguascalientes, 20127

  • Investigacion y Biomedicina de Chihuahua, S.C.

    Chihuahua City, 31000

  • Consultorio Privado Dr. Miguel Cortes Hernandez

    Cuernavaca, Morelos, 62448

  • Centro de investigacion medica y reumatologia

    Guadalajara, Jalisco, 44959

  • Medical Care & Research SA de CV

    Mérida, Yucatán, 97070

  • Centro de Investigacion Clínica GRAMEL S.C

    Mexico City, Mexico City, 3720

  • Clinstile, S.A. de C.V.

    Mexico City, Mexico City, 6700

Other trials in Mexico

South Korea7 sites

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 15355

  • Chungnam National University Hospital

    Daejeon, 35015

  • Chonnam National University Hospital

    Gwangju, 61469

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722

  • Hanyang University Seoul Hospital

    Seoul, 4763

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 6591

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Canada5 sites

  • Laser Rejuvenation Clinics, Inc.

    Calgary, Alberta, T2W 4X9

  • Laster Rejuvenation Clinics Edmonton D.T. Inc.

    Edmonton, Alberta, T5J 3S9

  • Medicor Research Inc

    Greater Sudbury, Ontario, P3C 1X3

  • Dermatology Ottawa Research Centre

    Ottawa, Ontario, K2C 3N2

  • DIEX Recherche Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8

Other trials in Canada

Portugal5 sites

  • Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)

    Coimbra, 3000-075

  • Hospital de Egas Moniz

    Lisbon, 1349-019

  • Hospital CUF Descobertas

    Lisbon, 1998-018

  • Centro Hospitalar Universitártio do Porto, E.P.E.

    Porto, 4099-001

  • Unidade Local de Saúde do Alto Minho, E.P.E.

    Viana do Castelo, 4904-858

Other trials in Portugal

Taiwan5 sites

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    Changhua, 50004

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • Chung Shan Medical University Hospital

    Taichung, 40201

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Belgium4 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, Vlaams-Brabant, 03000

  • Centre Hospitalier Universitaire de Liege

    Liège, 4000

Other trials in Belgium

Colombia4 sites

  • Centro de Investigacion Medico Asistencial S.A.S

    Barranquilla, Atlántico, 80020

  • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM

    Bogotá, 110221

  • Servimed S.A.S.

    Bucaramanga, Santander Department, 680003

  • Healthy Medical Center

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Serbia4 sites

  • Institute of Rheumatology

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

  • University Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

United Kingdom4 sites

  • Queen Elizabeth Hospital

    Birmingham, West Midlands, B15 2GW

  • Chapel Allerton Hospital

    Leeds, West Yorkshire, LS9 7TF

  • Whipps Cross University Hospital

    London, Greater London, E11 1NR

  • Manchester Royal Infirmary

    Manchester, Greater Manchester, M13 9WL

Other trials in United Kingdom

Hungary3 sites

  • Semmelweis Egyetem

    Budapest, 1085

  • Pecsi Tudomanyegyetem

    Pécs, 7632

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6720

Other trials in Hungary

Switzerland3 sites

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, CH-1011

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • Universitaetsspital Zuerich

    Zurich-Flughafen, Canton of Zurich, 8058

Other trials in Switzerland

Peru2 sites

  • ACQ MEDIC SAC - Centro de Investigacion Clinica Inmunoreumatologia

    Lima, Lima 11

  • Invest Clinicas Sac Inst de Ginecologia y Reproduccion

    Lima, Lima 33

Other trials in Peru

Puerto Rico2 sites

  • Dr. Samuel Sanchez PSC

    Caguas, 00727

  • GCM Medical Group PSC - Hato Rey

    San Juan, 917

Other trials in Puerto Rico

Saudi Arabia2 sites

  • King Faisal Specialist Hospital & Research Center

    Riyadh, 11211

  • King Saud University

    Riyadh, 11461

Other trials in Saudi Arabia

Slovakia2 sites

  • Artromac n.o.

    Košice, 4011

  • Narodny ustav reumatickych chorob

    Piešťany, 92112

Other trials in Slovakia

Sweden1 site

  • Karolinska Universitetssjukhuset - Solna

    Stockholm, 17176

Other trials in Sweden

About this study

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)

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).

Read more

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.
Read the detailed description

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].

Being tested
Litifilimab, Placebo
Keywords
Cutaneous Lupus Erythematosus (CLE), Discoid Lupus Erythematosus (DLE), Systemic Lupus Erythematosus (SLE), Lupus, Subacute Cutaneous Lupus Erythematosus (SCLE)
Medical subject headings
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LitifilimabDrug

    Also called BIIB059

    Administered as specified in the treatment arm.

  • PlaceboDrug

    Administered as specified in the treatment arm.

Study groups in NCT05531565
Study groupRoleWhat they receive
Part A (Phase 2): LitifilimabExperimentalParticipants will receive litifilimab subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the double-blind placebo-controlled (DBPC) treatment period. Following the DBPC treatment period, participants will receive litifilimab during the extended treatment period (ETP) from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26.
Receives: Drug: Litifilimab
Part A (Phase 2): PlaceboPlacebo comparatorParticipants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26.
Receives: Drug: Placebo
Part B (Phase 3): LitifilimabExperimentalParticipants will receive litifilimab SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab-matching placebo at Week 26.
Receives: Drug: Litifilimab
Part B (Phase 3): PlaceboPlacebo comparatorParticipants will receive litifilimab-matching placebo SC Q4W from Week 0 to Week 20, with an additional dose of litifilimab-matching placebo at Week 2 during the DBPC treatment period. Following the DBPC treatment period, participants will receive litifilimab during the ETP from Week 24 to Week 48, with an additional dose of litifilimab at Week 26.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 16

  2. 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

    Measured: Baseline to Week 24

Secondary outcomes (55)

  1. Part A: Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab During the DBPC Treatment Period (TP)

    Measured: Week 52

  2. Part A: Percentage of Participants With CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  3. Part A: Percentage of Participants With CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Responders at Weeks 16 &24, Respectively, who Were Assigned to Receive Litifilimab in DBPC TP

    Measured: Week 52

  4. Part A: Percentage of Participants With CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Responders With CLA-IGA-R OMC Score of 0 at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Litifilimab During DBPC TP

    Measured: Week 52

  5. Part A: Percentage of Participants With CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab in DBPC TP

    Measured: Week 52

  6. Part A: Percentage of Participants With a CLASI-70 Response at Week 52 Among CLASI-70 Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP

    Measured: Week 52

  7. Part A: Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP

    Measured: Week 52

  8. Part A: Percentage of Participants With CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Nonresponders at Weeks 16 and 24, Respectively, who Were Assigned to Receive Placebo in DBPC TP

    Measured: Week 52

  9. Part A: Percentage of Participants With a CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP

    Measured: Week 52

  10. Part A: Percentage of Participants who Have CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Nonresponders at Weeks 16 and 24, Respectively, who Were Randomly Assigned to Receive Placebo in DBPC TP

    Measured: Week 52

  11. Part A: Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 16

    Measured: Up to Week 16

  12. Part A: Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score at Week 52

    Measured: Baseline to Week 52

  13. Part A: Percent Change in CLASI-D Score

    Measured: Baseline to Week 52

  14. Part B: Percentage of Participants who Achieve a CLASI A score of 0 to 3

    Measured: Week 24

  15. Part B: Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1 and at Least 2-Point Improvement From Baseline at Week 24, for Participants who had CLA-IGA-R OMC Score ≥ 2 at Baseline

    Measured: Week 24

  16. Part B: Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score ≥3 and Other OMC Score ≥3 at Baseline

    Measured: Weeks 16 and 24

  17. Part B: Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline

    Measured: Weeks 16 and 24

  18. Part B: Percentage of Participants who Achieve CLA IGA R Erythema Score of 0 or 1

    Measured: Up to Week 24

  19. Part B: Percentage of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score

    Measured: Up to Week 24

  20. Part B: Percentage of Participants who Achieve a CLASI-A Score of 0 to 5

    Measured: Up to Week 24

  21. Part B: Percentage of Participants who Achieve a CLASI-50a Response, Defined as a ≥ 50% Decrease in Baseline CLASI-A Score in Addition to Achieving Mild Disease Severity With a CLASI-A Score <10 at Week 16 and Week 24, Respectively

    Measured: Weeks 16 and 24

  22. Part B: Percentage of Participants With a CLASI 70 Response at Week 52 Among CLASI-70 Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  23. Part B: Percentage of Participants With a CLASI 50 Response at Week 52 Among CLASI-50 Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  24. Part B: Percentage of Participants With a CLASI A 0 to 3 Response at Week 52 Among CLASI-A 0 to 3 Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  25. Part B: Percentage of Participants With a CLA IGA R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  26. Part B: Percentage of Participants With a CLA IGA R OMC score of 0 at Week 52 Among CLA IGA R OMC Responders With a CLA-IGA-R OMC Score of 0 at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  27. Part B: Percentage of Participants With a CLA IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  28. Part B: Percentage of Participants With a CLASI 70 Response at Week 52 Among CLASI-70 Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  29. Part B: Percentage of Participants With a CLASI 50 Response at Week 52 Among CLASI-50 Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  30. Part B: Percentage of Participants With a CLASI A 0 to 3 Response at Week 52 Among CLASI-A 0 to 3 Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  31. Part B: Percentage of Participants With a CLA IGA R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  32. Part B: Percentage of Participants With a CLA IGA R OMC score of 0 at Week 52 Among CLA IGA R OMC Nonresponders With a CLA-IGA-R OMC Score of 0 at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  33. Part B: Percentage of Participants With a CLA IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Nonresponders at Week 24, who Were Randomly Assigned to Receive Litifilimab During the DBPC TP

    Measured: Week 52

  34. Part B: Absolute Change in CLASI-D Score

    Measured: Week 52

  35. Part B: Percent Change in CLASI-D Score

    Measured: Week 52

  36. Part B: Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score

    Measured: Part B: Weeks 16, 24 and 52

  37. Part B: Change From Baseline in Dermatology Life Quality Index (DLQI) Score

    Measured: Part B: Weeks 16, 24 and 52

  38. Part B: Change From Baseline in Numerical Rating Scale (NRS) for Pain in Skin Rash

    Measured: Part B: Weeks 16, 24 and 52

  39. Part B: Change From Baseline in NRS for Itch in Skin Rash

    Measured: Part B: Weeks 16, 24 and 52

  40. Parts A and B: Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1

    Measured: Part A: Week 24; Part B: Weeks 16 and 24

  41. Parts A and B: Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 and at Least 1 Level of Improvement From Baseline

    Measured: Part A: Weeks 16 and 24; Part B: Up to Week 24

  42. Parts A and B: Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0

    Measured: Part A: Weeks 16 and 24; Part B: Up to Week 24

  43. Parts A and B: Percentage of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score

    Measured: Part A: Weeks 16 and 24; Part B: Up to Week 24

  44. Parts A and B: Percentage of Participants who Have a CLA-IGA-R Follicular Activity Score of 0

    Measured: Part A: Weeks 16 and 24; Part B: Up to Week 24

  45. Parts A and B: Percentage of Participants who Achieve a CLASI-70 Response, Defined as a ≥ 70% Decrease in CLASI-A Score From Baseline

    Measured: Parts A: Weeks 16 and 24; Part B: Week 12

  46. Parts A and B: Percentage of Participants who Achieve a CLASI-50 Response, Defined as a ≥ 50% Decrease in CLASI-A Score From Baseline

    Measured: Part A: Weeks 16 and 24; Part B: Weeks 12 and 24

  47. Parts A and B: Percentage of Participants who Achieve a CLASI-A Score of 0 or 1

    Measured: Up to Week 24

  48. Parts A and B: Percentage of Participants who Achieve a CLASI-A Score of 0 to 3

    Measured: Up to Week 24

  49. Parts A and B: Percentage of Participants who Achieve a CLASI 70 Response

    Measured: Up to Week 24

  50. Parts A and B: Percentage of Participants who Achieve a CLASI 50 Response

    Measured: Up to Week 24

  51. Parts A and B: Percentage of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A Score

    Measured: Up to Week 24

  52. Parts A and B: Annualized Mild and Moderate Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index Rate and Annualized Severe SFI Rate Through Week 24

    Measured: Up to Week 24

  53. Parts A and B: Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 52

    Measured: Up to Week 52

  54. Parts A and B: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Up to Week 76

  55. Parts A and B: Number of Participants With Anti-Litifilimab Antibodies in Serum During the Study

    Measured: Up to Week 76

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2022
  2. Study start13 Sep 2022
  3. Primary completion20 Oct 2026 (estimated)
  4. Study completion14 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05531565
Sponsor's protocol ID
230LE301
Other IDs
2020-000727-40, EU CT Number
Acronym
AMETHYST
Status last verified
Oct 2026
First submitted
19 Aug 2022
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

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