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)

Status: Recruiting
Location: See all (263) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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 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%? 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Pinnacle Research Group, LLC
RECRUITING
Anniston
UAB Center for Women's Reproductive Health
RECRUITING
Birmingham
Arizona
Arizona Arthritis & Rheumatology Research, PLLC
RECRUITING
Phoenix
California
The Regents of the University of California
RECRUITING
La Jolla
Dermatology Research Associates
RECRUITING
Los Angeles
Clinical Science Institute
COMPLETED
Santa Monica
Inland Rheumatology Clinical Trials, Inc.
RECRUITING
Upland
Colorado
Denver Arthritis Clinic
COMPLETED
Denver
Florida
Omega Research Debary, LLC
RECRUITING
Debary
Centre for Rheumatology, Immunology and Arthritis
COMPLETED
Fort Lauderdale
University of Florida
COMPLETED
Gainesville
Diverse Clinical Research LLC
RECRUITING
Miami
Medical Research Center of Miami
COMPLETED
Miami
University of Miami Miller School of Medicine
RECRUITING
Miami
Charisma Medical and Research Center
RECRUITING
Miami Lakes
Leading Edge Dermatology
RECRUITING
Plantation
Georgia
Augusta University
RECRUITING
Augusta
Illinois
Rush University Medical Center
RECRUITING
Chicago
OrthoIllinois
COMPLETED
Rockford
Indiana
Dawes Fretzin Clinical Research Group, LLC
COMPLETED
Indianapolis
Kentucky
Equity Medical
RECRUITING
Bowling Green
Louisiana
LSU Health Sciences Center Shreveport
RECRUITING
New Orleans
Massachusetts
Brigham And Women's Hospital
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Essential Dermatology
COMPLETED
Natick
Beacon Clinical Research, LLC
RECRUITING
Quincy
University of Massachusetts, Worcester
COMPLETED
Worcester
Michigan
David Fivenson, MD, Dermatology, PLLC
RECRUITING
Ann Arbor
Oakland Hills Dermatology
RECRUITING
Auburn Hills
AA MRC LLC Ahmed Arif Medical Research Center
COMPLETED
Flint
Revival Research Institute, LLC
RECRUITING
Troy
Missouri
Saint Louis University
RECRUITING
St Louis
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Duke Dermatology South Durham
RECRUITING
Durham
Medication Management, LLC
COMPLETED
Greensboro
Nebraska
University of Nebraska Medical Center
COMPLETED
Omaha
New Mexico
Albuquerque Center For Rheumatology
COMPLETED
Albuquerque
University of New Mexico School of Medicine
COMPLETED
Albuquerque
New York
NYU Langone Brooklyn
RECRUITING
Brooklyn
Universal Dermatology, PLLC
RECRUITING
Fairport
Northwell Health, Inc. PRIME
RECRUITING
Great Neck
Columbia University Medical center
RECRUITING
New York
Ohio
University of Cincinnati Department of Dermatology
RECRUITING
Cincinnati
University Hospitals Cleveland Medical Center
COMPLETED
Cleveland
Ohio State University
COMPLETED
Columbus
Pennsylvania
Penn State University Milton S. Hershey Medical Center
COMPLETED
Hershey
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Austin Regional Clinic, P.A.
RECRUITING
Austin
Precision Comprehensive Clinical Research Solutions
RECRUITING
Colleyville
Metroplex Clinical Research Center, LLC
COMPLETED
Dallas
UT Southwestern Medical Center
RECRUITING
Dallas
North Texas Center for Clinical Research
RECRUITING
Frisco
UTMB Department of Dermatology
RECRUITING
Galveston
University of Texas Health Science Center at Houston
RECRUITING
Houston
Arthritis & Osteoporosis Clinic
RECRUITING
Waco
Utah
University of Utah Health Sciences Center
RECRUITING
Salt Lake City
Virginia
West End Dermatology Associates
COMPLETED
Richmond
Other Locations
Argentina
APRILLUS Asistencia e Investigacion
RECRUITING
Buenos Aires
Fundacion Respirar
RECRUITING
Buenos Aires
Hospital Italiano de La Plata
RECRUITING
Buenos Aires
CINME - Centro De Investigaciones Metabolicas
COMPLETED
Caba
Centro Privado de Medicina Familiar - Mind Out Research
RECRUITING
Ciudad Autonoma Buenos Aires
Clinica Adventista Belgrano
RECRUITING
Ciudad Autonoma Buenos Aires
Centro de Investigaciones Medicas Mar del Plata
RECRUITING
Mar Del Plata
Instituto de Reumatologia
RECRUITING
Mendoza
Instituto de Investigaciones Clinicas Quilmes
RECRUITING
Quilmes
Instituto CAICI
RECRUITING
Rosario
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
RECRUITING
San Juan
Centro de Investigaciones Medicas Tucuman
RECRUITING
San Miguel De Tucumán
Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
RECRUITING
San Miguel De Tucumán
Investigaciones Clinicas Tucuman
RECRUITING
San Miguel De Tucumán
Brazil
Santa Casa de Misericordia de Belo Horizonte
RECRUITING
Belo Horizonte
L2IP - Instituto de Pesquisas Clínicas Ltda.
RECRUITING
Brasília
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
RECRUITING
Fortaleza
CMiP - Centro Mineiro de Pesquisa
RECRUITING
Juiz De Fora
Hospital Bruno Born
RECRUITING
Lajeado
Hospital de Clínicas de Porto Alegre
RECRUITING
Porto Alegre
LMK Serviços Médicos S/S Ltda
RECRUITING
Porto Alegre
Nucleo de Pesquisa Clinica do Rio Grande do Sul
RECRUITING
Porto Alegre
IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda
RECRUITING
Rio De Janeiro
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
RECRUITING
Rio De Janeiro
Clínica SER da Bahia
RECRUITING
Salvador
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
RECRUITING
Santo Ângelo
CEMEC - Centro Multidisciplinar de Estudos Clínicos
RECRUITING
São Bernardo Do Campo
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
RECRUITING
São Paulo
A2Z Clinical Centro Avancado de Pesquisa Clinica
RECRUITING
Valinhos
CEDOES - Diagnóstico e Pesquisa
RECRUITING
Vitória
Bulgaria
Medical center Medconsult Pleven OOD
RECRUITING
Pleven
UMHAT 'Dr. Georgi Stranski', EAD
RECRUITING
Pleven
DCC 1 - Ruse, EOOD
COMPLETED
Rousse
DCC 'Alexandrovska', EOOD
RECRUITING
Sofia
DCC Focus 5 - MEOH OOD
RECRUITING
Sofia
DCC Focus 5 - MEOH OOD
RECRUITING
Sofia
Military Medical Academy - MHAT - Sofia
RECRUITING
Sofia
Canada
Laser Rejuvenation Clinics, Inc.
RECRUITING
Calgary
Laster Rejuvenation Clinics Edmonton D.T. Inc.
RECRUITING
Edmonton
Medicor Research Inc
COMPLETED
Greater Sudbury
Dermatology Ottawa Research Centre
COMPLETED
Ottawa
DIEX Recherche Sherbrooke Inc.
RECRUITING
Sherbrooke
Chile
Centro Medico SkinMed
RECRUITING
Las Condes
BioMedica Research Group
RECRUITING
Santiago
CeCim Biocinetic
RECRUITING
Santiago
CIEC - Centro Internacional de Estudios Clínicos
RECRUITING
Santiago
Dermacross
RECRUITING
Santiago
Clinical Research Chile SpA.
RECRUITING
Valdivia
Oncocentro APYS
RECRUITING
Viña Del Mar
China
The First Affiliated Hospital of Baotou Medical College
RECRUITING
Baotou
Beijing Tongren Hospital, Capital Medical University
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
The second Xiangya Hospital of Central South University
RECRUITING
Changsha
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Dongguan People's Hospital
RECRUITING
Dongguan
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
RECRUITING
Guangzhou
Hangzhou First People's Hospital
RECRUITING
Hangzhou
The First Affiliated Hospital of Zhejiang University school of medicine
RECRUITING
Hangzhou
Qilu Hospital of Shandong University
RECRUITING
Jinan
The Second Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
RECRUITING
Nanjing
Nanyang First People's Hospital
RECRUITING
Nanyang
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shanghai Skin Disease Hospital
RECRUITING
Shanghai
Zhongshan Hospital Fudan University
RECRUITING
Shanghai
Shenzhen Second People's Hospital
RECRUITING
Shenzhen
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
Colombia
Centro de Investigacion Medico Asistencial S.A.S
RECRUITING
Barranquilla
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
RECRUITING
Bogotá
Servimed S.A.S.
RECRUITING
Bucaramanga
Healthy Medical Center
RECRUITING
Zipaquirá
France
Hôpital Privé d'Antony
RECRUITING
Antony
CHU Besançon - Hôpital Jean Minjoz
RECRUITING
Besançon
CHU de Caen - Hopital de la Cote de Nacre
RECRUITING
Caen
Hôpital Saint-Louis
RECRUITING
Cedex 10
Hopital Edouard Herriot - CHU Lyon
RECRUITING
Lyon
Hôpital de la Timone
COMPLETED
Marseille
Hopital Saint Eloi
RECRUITING
Montpellier
CHU Nice - Hopital de l Archet
RECRUITING
Nice
Hopital Tenon
RECRUITING
Paris
Hopital Larrey
RECRUITING
Toulouse
Germany
Universitaetsklinikum Aachen AoeR
RECRUITING
Aachen
Fachklinik Bad Bentheim Dermatologie
RECRUITING
Bad Bentheim
Charité - Campus Charité Mitte
RECRUITING
Berlin
Universitaetsklinikum Bonn AoeR
RECRUITING
Bonn
Elbekliniken Buxtehude GmbH
RECRUITING
Buxtehude
Universitaetsklinikum Carl Gustav Carus TU Dresden
RECRUITING
Dresden
Universitaetsklinikum Duesseldorf AoeR
RECRUITING
Düsseldorf
Universitaetsklinikum Erlangen
RECRUITING
Erlangen
Universitaetsklinikum Halle (Saale)
RECRUITING
Halle
Universitaetsklinikum Heidelberg
RECRUITING
Heidelberg
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
COMPLETED
Kiel
Universitaetsklinikum Muenster
RECRUITING
Münster
Klinikum Oldenburg AoeR
RECRUITING
Oldenburg
Hungary
Pecsi Tudomanyegyetem
RECRUITING
Pécs
Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
RECRUITING
Bologna
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
RECRUITING
Brescia
Università degli studi di Firenze
RECRUITING
Florence
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genova
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliera Universitaria Policlinico 'Federico II'
RECRUITING
Napoli
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Japan
Aomori Prefectural Central Hospital
RECRUITING
Aomori
Teikyo University Hospital
RECRUITING
Itabashi-ku
Shimane University Hospital
RECRUITING
Izumo-shi
Kakogawa Central City Hospital
RECRUITING
Kakogawa-shi
Kanazawa University Hospital
RECRUITING
Kanazawa
NHO Osaka Minami Medical Center
RECRUITING
Kawachinagano-shi
St. Marianna University Hospital
RECRUITING
Kawasaki-shi
Hospital of the University of Occupational and Environmental Health
RECRUITING
Kitakyushu-shi
Kumamoto University Hospital
RECRUITING
Kumamoto
Nagasaki University Hospital
RECRUITING
Nagasaki
JCHO Chukyo Hospital
RECRUITING
Nagoya
NHO Nagoya Medical Center
RECRUITING
Nagoya
Niigata University Medical & Dental Hospital
RECRUITING
Niigata
Japanese Red Cross Okayama Hospital
RECRUITING
Okayama
Kita Harima Medical Center
COMPLETED
Ono-shi
Daini Osaka Police Hospital
RECRUITING
Osaka
Kindai University Hospital
RECRUITING
Osakasayama-shi
Shiga University of Medical Science Hospital
RECRUITING
Ōtsu
Hokkaido University Hospital
RECRUITING
Sapporo
Tohoku University Hospital
RECRUITING
Sendai
Showa University East Hospital
RECRUITING
Shinagawa-ku
Osaka University Hospital
RECRUITING
Suita-shi
Takatsuki Red Cross Hospital
RECRUITING
Takatsuki-shi
Fujita Health University Hospital
RECRUITING
Toyoake-shi
Juntendo University Urayasu Hospital
RECRUITING
Urayasu-shi
Wakayama Medical University Hospital
RECRUITING
Wakayama
NHO Yokohama Medical Center
RECRUITING
Yokohama
Yokohama City University Hospital
RECRUITING
Yokohama
Yokohama City University Medical Center
RECRUITING
Yokohama
University of Fukui Hospital
RECRUITING
Yoshida-gun
Mexico
Derma Norte del Bajio S.C.
RECRUITING
Aguascalientes
Investigacion y Biomedicina de Chihuahua, S.C.
RECRUITING
Chihuahua City
Consultorio Privado Dr. Miguel Cortes Hernandez
RECRUITING
Cuernavaca
Centro de investigacion medica y reumatologia
RECRUITING
Guadalajara
Medical Care & Research SA de CV
RECRUITING
Mérida
Centro de Investigacion Clínica GRAMEL S.C
RECRUITING
Mexico City
Clinstile, S.A. de C.V.
RECRUITING
Mexico City
Peru
Invest Clinicas Sac Inst de Ginecologia y Reproduccion
RECRUITING
Lima
Philippines
Cebu Doctors University Hospital
RECRUITING
Cebu City
Mary Mediatrix Medical Center
RECRUITING
Lipa City
The Medical City Clark
RECRUITING
Mabalacat
Jose R. Reyes Memorial Medical Center
RECRUITING
Manila
Medical Center Manila
RECRUITING
Manila
Philippine General Hospital
RECRUITING
Manila
St. Luke's Medical Center
RECRUITING
Quezon City
Far Eastern University - Dr. Nicanor Reyes Medical Foundation
RECRUITING
Quezon City, Metro Manila
Ilocos Training and Regional Medical Center
RECRUITING
San Fenando, La Union
Poland
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski
COMPLETED
Krakow
SPZOZ Szpital Uniwersytecki w Krakowie
COMPLETED
Krakow
Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A Lesiak
RECRUITING
Lodz
Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina
RECRUITING
Rzeszów
Royalderm
RECRUITING
Warsaw
Szpital Kliniczny Dzieciatka Jezus
RECRUITING
Warsaw
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska
RECRUITING
Wroclaw
Portugal
Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)
RECRUITING
Coimbra
Hospital CUF Descobertas
RECRUITING
Lisbon
Hospital de Egas Moniz
RECRUITING
Lisbon
Centro Hospitalar Universitártio do Porto, E.P.E.
RECRUITING
Porto
Unidade Local de Saúde do Alto Minho, E.P.E.
COMPLETED
Viana Do Castelo
Puerto Rico
Dr. Samuel Sanchez PSC
COMPLETED
Caguas
GCM Medical Group PSC - Hato Rey
RECRUITING
San Juan
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan-si
Chonnam National University Hospital
RECRUITING
Gwangju
Hanyang University Seoul Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Saudi Arabia
King Faisal Specialist Hospital & Research Center
RECRUITING
Riyadh
King Saud University
RECRUITING
Riyadh
Serbia
Institute of Rheumatology
RECRUITING
Belgrade
University Clinical Center of Serbia
RECRUITING
Belgrade
University Clinical Center Kragujevac
RECRUITING
Kragujevac
Clinical Center of Vojvodina
RECRUITING
Novi Sad
Slovakia
Artromac n.o.
RECRUITING
Košice
Narodny ustav reumatickych chorob
RECRUITING
Piešťany
Spain
Complejo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital Universitario Fundacion Alcorcon
RECRUITING
Alcorcón
Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron - VHIR
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Universitario Rio Hortega
RECRUITING
Valladolid
Sweden
Karolinska Universitetssjukhuset - Solna
RECRUITING
Stockholm
Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITING
Lausanne
Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
Universitaetsspital Zuerich
RECRUITING
Zurich-flughafen
Taiwan
Changhua Christian Medical Foundation Changhua Christian Hospital
RECRUITING
Changhua
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
Queen Elizabeth Hospital
RECRUITING
Birmingham
Chapel Allerton Hospital
RECRUITING
Leeds
Whipps Cross University Hospital
RECRUITING
London
Manchester Royal Infirmary
RECRUITING
Manchester
Contact Information
Primary
US Biogen Clinical Trial Center
clinicaltrials@biogen.com
866-633-4636
Backup
Global Biogen Clinical Trial Center
clinicaltrials@biogen.com
Time Frame
Start Date: 2022-09-13
Estimated Completion Date: 2027-12-14
Participants
Target number of participants: 474
Treatments
Experimental: Part A (Phase 2): Litifilimab
Participants 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.
Placebo_comparator: Part A (Phase 2): Placebo
Participants 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.
Experimental: Part B (Phase 3): Litifilimab
Participants 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.
Placebo_comparator: Part B (Phase 3): Placebo
Participants 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.
Sponsors
Leads: Biogen

This content was sourced from clinicaltrials.gov

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