A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
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)
3 other identifiers
interventional
450
29 countries
313
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2022
Longer than P75 for phase_2
313 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2022
CompletedFirst Posted
Study publicly available on registry
September 8, 2022
CompletedStudy Start
First participant enrolled
September 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 14, 2027
April 23, 2026
April 1, 2026
4.1 years
August 19, 2022
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (55)
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)
Week 52
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
Week 52
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
Week 52
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
Week 52
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
Week 52
- +50 more secondary outcomes
Study Arms (4)
Part A (Phase 2): Litifilimab
EXPERIMENTALParticipants 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.
Part A (Phase 2): Placebo
PLACEBO 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.
Part B (Phase 3): Litifilimab
EXPERIMENTALParticipants 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.
Part B (Phase 3): Placebo
PLACEBO 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.
Interventions
Administered as specified in the treatment arm.
Administered as specified in the treatment arm.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (314)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
UAB Center for Women's Reproductive Health
Birmingham, Alabama, 35233-7340, United States
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85032, United States
The Regents of the University of California
La Jolla, California, 92037, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, 91786, United States
Denver Arthritis Clinic
Denver, Colorado, 80230, United States
Omega Research Debary, LLC
DeBary, Florida, 32713, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33334, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Miami Miller School of Medicine
Miami, Florida, 33125, United States
Millennium Medical Research, LLC
Miami, Florida, 33126, United States
Medical Research Center of Miami
Miami, Florida, 33134, United States
Diverse Clinical Research LLC
Miami, Florida, 33175, United States
Charisma Medical and Research Center
Miami Lakes, Florida, 33014, United States
Leading Edge Dermatology
Plantation, Florida, 33317, United States
Augusta University
Augusta, Georgia, 30912, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
OrthoIllinois
Rockford, Illinois, 61114, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
Equity Medical
Bowling Green, Kentucky, 42104, United States
LSU Health Sciences Center Shreveport
New Orleans, Louisiana, 70112, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Brigham And Women's Hospital
Boston, Massachusetts, 02115, United States
Essential Dermatology
Natick, Massachusetts, 01760, United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, 02169, United States
University of Massachusetts, Worcester
Worcester, Massachusetts, 01655, United States
David Fivenson, MD, Dermatology, PLLC
Ann Arbor, Michigan, 48103, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326, United States
AA MRC LLC Ahmed Arif Medical Research Center
Flint, Michigan, 48504, United States
Revival Research Institute, LLC
Troy, Michigan, 48084, United States
Saint Louis University
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, 87102, United States
University of New Mexico School of Medicine
Albuquerque, New Mexico, 87106, United States
NYU Langone Brooklyn
Brooklyn, New York, 11220, United States
Universal Dermatology, PLLC
Fairport, New York, 14450, United States
Northwell Health, Inc. PRIME
Great Neck, New York, 11021, United States
Columbia University Medical center
New York, New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Duke Dermatology South Durham
Durham, North Carolina, 27710, United States
Medication Management, LLC
Greensboro, North Carolina, 27405, United States
University of Cincinnati Department of Dermatology
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Ohio State University
Columbus, Ohio, 43210, United States
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Austin Regional Clinic, P.A.
Austin, Texas, 78731, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034, United States
Metroplex Clinical Research Center, LLC
Dallas, Texas, 75231, United States
UT Southwestern Medical Center
Dallas, Texas, 75390-8896, United States
North Texas Center for Clinical Research
Frisco, Texas, 75034, United States
UTMB Department of Dermatology
Galveston, Texas, 77555-0583, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77054, United States
Arthritis & Osteoporosis Clinic
Waco, Texas, 76710, United States
Velocity Clinical Research Waco
Waco, Texas, 76710, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
Open Door Clinical Research
Blacksburg, Virginia, 24060, United States
West End Dermatology Associates
Richmond, Virginia, 23233, United States
CINME - Centro De Investigaciones Metabolicas
CABA, Buenos Aires, C1056ABI, Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, 7600, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires, B1878GEG, Argentina
Centro de Investigaciones San Miguel
San Miguel, Buenos Aires, 1663, Argentina
APRILLUS Asistencia e Investigacion
Buenos Aires, Ciudad Autonoma Buenos Aires, C1406AGA, Argentina
Fundacion Respirar
Buenos Aires, Ciudad Autonoma Buenos Aires, C1426ABO, Argentina
Consultorio Alto Dorrego
Villa Nueva, Mendoza Province, CP 5519, Argentina
Instituto CAICI
Rosario, Santa Fe Province, S2000PBJ, Argentina
Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Investigaciones Clinicas Tucuman
San Miguel de Tucumán, Tucumán Province, T4000ICL, Argentina
Hospital Italiano de La Plata
Buenos Aires, B1900AXI, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, C1199ABB, Argentina
Centro Privado de Medicina Familiar - Mind Out Research
Ciudad Autonoma Buenos Aires, C1417, Argentina
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, C1430EGF, Argentina
Instituto de Reumatologia
Mendoza, M5500, Argentina
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan, 5400, Argentina
UZ Leuven
Leuven, Vlaams-Brabant, 03000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Centre Hospitalier Universitaire de Liege
Liège, 4000, Belgium
Integrare Terapêutica
Fortaleza, Ceará, 60125-000, Brazil
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, Ceará, 60430-370, Brazil
CEDOES - Diagnóstico e Pesquisa
Vitória, Espírito Santo, 29055-450, Brazil
Clínica SER da Bahia
Salvador, Estado de Bahia, 40150-150, Brazil
L2IP - Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, 70200-730, Brazil
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Santo Ângelo, Mato Grosso, 78020-500, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Clinica Pulsus
Belo Horizonte, Minas Gerais, 30180-065, Brazil
CMiP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, 36010-570, Brazil
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
Rio de Janeiro, Rio Do Janeiro, 20241-180, Brazil
IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda
Rio de Janeiro, Rio Do Janeiro, 22470-220, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, 95900-000, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90430001, Brazil
LMK Serviços Médicos S/S Ltda
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560032, Brazil
IPES - Instituto de Pesquisa e Educação em Saúde
Porto Velho, Rondônia, 76804366, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, São Paulo, 09715-090, Brazil
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
São Paulo, São Paulo, 04266-010, Brazil
A2Z Clinical Centro Avancado de Pesquisa Clinica
Valinhos, São Paulo, 13271-130, Brazil
RDSS Ricardo Diaz Scientific Solution
São Paulo, 04037-030, Brazil
DCC-1-Sevlievo EOOD
Sevlievo, Gabrovo, 5400, Bulgaria
DCC 'Sveti Georgi' EOOD
Haskovo, 6300, Bulgaria
Medical center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800, Bulgaria
DCC 1 - Ruse, EOOD
Rousse, 7002, Bulgaria
Ambulatory for Specialized Medical Help - skin and venereal diseases
Sofia, 1407, Bulgaria
DCC 'Alexandrovska', EOOD
Sofia, 1431, Bulgaria
DCC 'Alexandrovska', EOOD
Sofia, 1431, Bulgaria
DCC Focus 5 - MEOH OOD
Sofia, 1463, Bulgaria
Military Medical Academy - MHAT - Sofia
Sofia, 1606, Bulgaria
Laser Rejuvenation Clinics, Inc.
Calgary, Alberta, T2W 4X9, Canada
Laster Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta, T5J 3S9, Canada
Medicor Research Inc
Greater Sudbury, Ontario, P3C 1X3, Canada
Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2, Canada
DIEX Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8, Canada
Centro Medico SkinMed
Las Condes, 7580206, Chile
Dermacross
Santiago, 66901, Chile
BioMedica Research Group
Santiago, 7500710, Chile
CeCim Biocinetic
Santiago, 8331143, Chile
CIEC - Centro Internacional de Estudios Clínicos
Santiago, 8420383, Chile
Clinical Research Chile SpA.
Valdivia, 5090000, Chile
Oncocentro APYS
Viña del Mar, 2520598, Chile
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Dongguan People's Hospital
Dongguan, Guangdong, 523059, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518029, China
Zhongshan TCM Hospital
Zhongshan, Guangdong, 528400, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangzhou, 510120, China
Nanyang First People's Hospital
Nanyang, Henan, 473004, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Xiangya Hospital of Central South University
Changsha, Hu'nan, 410008, China
The second Xiangya Hospital of Central South University
Changsha, Hu'nan, 410011, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014010, China
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, 210042, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200011, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650101, China
The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, Zhejiang, 310003, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, Atlántico, 80020, Colombia
Healthy Medical Center
Zipaquirá, Cundinamarca, 250252, Colombia
Servimed S.A.S.
Bucaramanga, Santander Department, 680003, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
Bogotá, 110221, Colombia
CHU Nice - Hopital de l Archet
Nice, Alpes Maritimes, 6200, France
Hôpital de la Timone
Marseille, Bouches-du-Rhône, 13385, France
CHU de Caen - Hopital de la Cote de Nacre
Caen, Calvados, 14033, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, 25030, France
Hopital Larrey
Toulouse, Haute Garonne, 31059, France
Hôpital Privé d'Antony
Antony, Hauts De Seine, 92160, France
Hopital Saint Eloi
Montpellier, Herault, 34295, France
Hopital Claude Huriez - CHU Lille
Lille, Nord, 59037, France
Hôpital Saint-Louis
Cedex 10, Paris, 75475, France
Hopital Edouard Herriot - CHU Lyon
Lyon, Rhone, 69003, France
Hopital Tenon
Paris, 75020, France
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
LMU-Campus Innenstadt
Munich, Bavaria, 80336, Germany
Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, 80802, Germany
Universitaetsklinikum Regensburg
Regensburg, Bavaria, 93053, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, 97080, Germany
Fachklinik Bad Bentheim Dermatologie
Bad Bentheim, Lower Saxony, 48455, Germany
Elbekliniken Buxtehude GmbH
Buxtehude, Lower Saxony, 21614, Germany
Klinikum Oldenburg AoeR
Oldenburg, Lower Saxony, 26133, Germany
Universitaetsklinikum Aachen AoeR
Aachen, North Rhine-Westphalia, 52074, Germany
Universitaetsklinikum Bonn AoeR
Bonn, North Rhine-Westphalia, 53127, Germany
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, 48149, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Saxony, 1307, Germany
Universitaetsklinikum Halle (Saale)
Halle, Saxony-Anhalt, 6120, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
Charité - Campus Charité Mitte
Berlin, 10117, Germany
Semmelweis Egyetem
Budapest, 1085, Hungary
Pecsi Tudomanyegyetem
Pécs, 7632, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6720, Hungary
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, 40138, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, 25123, Italy
Università degli studi di Firenze
Florence, 50121, Italy
IRCCS Ospedale Policlinico San Martino
Genova, 16132, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliera Universitaria Policlinico 'Federico II'
Naples, 80131, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 137, Italy
JCHO Chukyo Hospital
Nagoya, Aichi-ken, 457-8510, Japan
NHO Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001, Japan
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, 470-1192, Japan
Aomori Prefectural Central Hospital
Aomori, Aomori, 030-8553, Japan
Juntendo University Urayasu Hospital
Urayasu-shi, Chiba, 279-0021, Japan
University of Fukui Hospital
Yoshida-gun, Fukui, 910-1193, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka, 807-8556, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kakogawa Central City Hospital
Kakogawa-shi, Hyōgo, 675-8611, Japan
Kita Harima Medical Center
Ono-shi, Hyōgo, 675-1392, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
NHO Yokohama Medical Center
Yokohama, Kanagawa, 245-8575, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata, 951-8520, Japan
Japanese Red Cross Okayama Hospital
Okayama, Okayama-ken, 700-8607, Japan
NHO Osaka Minami Medical Center
Kawachinagano-shi, Osaka, 586-8521, Japan
Daini Osaka Police Hospital
Osaka, Osaka, 543-8922, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511, Japan
Osaka University Hospital
Suita-shi, Osaka, 565-0871, Japan
Takatsuki Red Cross Hospital
Takatsuki-shi, Osaka, 569-1096, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192, Japan
Shimane University Hospital
Izumo-shi, Shimane, 693-8501, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo-To, 173-8606, Japan
Showa University East Hospital
Shinagawa-ku, Tokyo-To, 142-0054, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
Centro de investigacion medica y reumatologia
Guadalajara, Jalisco, 44959, Mexico
Centro de Investigacion Clínica GRAMEL S.C
Mexico City, Mexico City, 3720, Mexico
Clinstile, S.A. de C.V.
Mexico City, Mexico City, 6700, Mexico
Consultorio Privado Dr. Miguel Cortes Hernandez
Cuernavaca, Morelos, 62448, Mexico
Medical Care & Research SA de CV
Mérida, Yucatán, 97070, Mexico
Derma Norte del Bajio S.C.
Aguascalientes, 20127, Mexico
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City, 31000, Mexico
ACQ MEDIC SAC - Centro de Investigacion Clinica Inmunoreumatologia
Lima, Lima 11, Peru
Invest Clinicas Sac Inst de Ginecologia y Reproduccion
Lima, Lima 33, Peru
The Medical City Clark
Mabalacat, Pampanga, 2023, Philippines
Cebu Doctors University Hospital
Cebu City, 6000, Philippines
Ospital Ng Makati
City of Taguig, 1642, Philippines
Mary Mediatrix Medical Center
Lipa City, 4217, Philippines
Medical Center Manila
Manila, 1000, Philippines
Philippine General Hospital
Manila, 1000, Philippines
Jose R. Reyes Memorial Medical Center
Manila, 1012, Philippines
The Medical City
Pasig, 1605, Philippines
St. Luke's Medical Center
Quezon City, 1102, Philippines
Far Eastern University - Dr. Nicanor Reyes Medical Foundation
Quezon City, Metro Manila, 1118, Philippines
Ilocos Training and Regional Medical Center
San Fenando, La Union, 2500, Philippines
Lorma Medical Center
San Fernando City, La Union, 2500, Philippines
DERMEDIC Jacek Zdybski
Kielce, 25-553, Poland
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31-501, Poland
Promed P.Lach R.Glowacki spolka jawna, Centrum Medyczne PROMED
Krakow, 31-513, Poland
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski
Krakow, 31-530, Poland
MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapinski
Krosno, 38-400, Poland
Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A Lesiak
Lodz, 90-436, Poland
Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina
Rzeszów, 35-055, Poland
MICS Centrum Medyczne Warszawa
Warsaw, 00-874, Poland
Szpital Kliniczny Dzieciatka Jezus
Warsaw, 02-008, Poland
Royalderm
Warsaw, 02-962, Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
Wroclaw, 50-566, Poland
Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)
Coimbra, 3000-075, Portugal
Hospital de Egas Moniz
Lisbon, 1349-019, Portugal
Hospital CUF Descobertas
Lisbon, 1998-018, Portugal
Centro Hospitalar Universitártio do Porto, E.P.E.
Porto, 4099-001, Portugal
Unidade Local de Saúde do Alto Minho, E.P.E.
Viana do Castelo, 4904-858, Portugal
Dr. Samuel Sanchez PSC
Caguas, 00727, Puerto Rico
GCM Medical Group PSC - Hato Rey
San Juan, 917, Puerto Rico
King Faisal Specialist Hospital & Research Center
Riyadh, 11211, Saudi Arabia
King Saud University
Riyadh, 11461, Saudi Arabia
Institute of Rheumatology
Belgrade, 11000, Serbia
University Clinical Center of Serbia
Belgrade, 11000, Serbia
University Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Clinical Center of Vojvodina
Novi Sad, 21000, Serbia
Artromac n.o.
Košice, 4011, Slovakia
Narodny ustav reumatickych chorob
Piešťany, 92112, Slovakia
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 3722, South Korea
Hanyang University Seoul Hospital
Seoul, 4763, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 8916, Spain
Hospital Universitario Rio Hortega
Valladolid, Cantabria, 47012, Spain
Hospital General de Castellon
Castellon, Castellón, 12004, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Universitari Vall d'Hebron - VHIR
Barcelona, 08035, Spain
Hospital del Mar
Barcelona, 8003, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Karolinska Universitetssjukhuset - Solna
Stockholm, 17176, Sweden
Universitaetsspital Zuerich
Zurich-Flughafen, Canton of Zurich, 8058, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, CH-1011, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, 9007, Switzerland
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, 50004, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
CNE Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, 18009, Ukraine
CNCE Regional Clinical Hospital of Ivano-Frankivsk Regional Council, Dept of Rheumatology
Ivano-Frankivsk, 76018, Ukraine
Medical Center Artes Medicum LLC
Kyiv, 02002, Ukraine
Med Center 'Ok!Clinic+' LLC "International Institute of Clinical Research"
Kyiv, 02091, Ukraine
Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council
Lutsk, 43005, Ukraine
UH of State NPE "Danulo Halytsky NMU in Lviv" CID, Rheum. Dept. of Marian Panchyshyn Campus
Lviv, 79010, Ukraine
Communal Enterprise M.V.Sklifosovskyi Poltava Regional Clinical Hospital of Poltava Regional Council
Poltava, 36011, Ukraine
CNE Ternopil Reg Clinical Hospital TRC, Dept of Rheumatology, SHEI I.Ya.HorbachevskyiTernopil SMU
Ternopil, 46002, Ukraine
ZAKARPATTIA ENDOCLINIC LLC, Medical Center Endoclinic
Uzhhorod, 88000, Ukraine
Private Small Enterprise Medical Center Pulse
Vinnytsia, 21001, Ukraine
СNE M.I. Pyrogov RCH of Vinnytsia RC HSC Reum Osteo Bio Th
Vinnytsia, 21018, Ukraine
Whipps Cross University Hospital
London, Greater London, E11 1NR, United Kingdom
Manchester Royal Infirmary
Manchester, Greater Manchester, M13 9WL, United Kingdom
Queen Elizabeth Hospital
Birmingham, West Midlands, B15 2GW, United Kingdom
Chapel Allerton Hospital
Leeds, West Yorkshire, LS9 7TF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2022
First Posted
September 8, 2022
Study Start
September 13, 2022
Primary Completion (Estimated)
October 20, 2026
Study Completion (Estimated)
December 14, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/