An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

NCT05352919 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 3 other identifiers: 230LE3062021-006378-222023-505635-13
• Study Type: interventional
• Target: 864
• Locations: 26 countries
• Sites: 185

Brief Summary

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will enroll participants who completed the treatment periods of either one of the parent studies. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is: \- How many participants have adverse events and serious adverse events? Researchers will also learn about the effect litifilimab has on controlling symptoms of SLE and lowering its activity. They will measure symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the British Isles Lupus Activity Group-2004 (BILAG-2004), among others. Researchers will also study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows:

• The Week 52 visit of studies 230LE303 and 230LE304 will be Day 1 of this study.
• Participants who were receiving either a high or low dose of litifilimab in the parent studies will continue receiving the same doses.
• Participants who were receiving placebo in the parent studies will be randomized to receive either a high or low dose of litifilimab.
• All participants will receive litifilimab as injections under the skin once every 4 weeks. The treatment period will last 156 weeks. Participants may continue to take their standard of care medications.
• Neither the researchers nor the participants will know which doses of litifilimab the participants are receiving.
• There will be a follow-up safety period that lasts up to 24 weeks.
• In total, participants will have up to 47 study visits. The total study duration for participants will be up to 180 weeks. Optional Substudy: Some participants may be invited to join an optional substudy after being in the main study for at least 4 months. This substudy will test a new injector device for giving litifilimab. The injector device is an automatic device that delivers the full dose in one injection without needing to push a plunger. Researchers will compare the safety and tolerability of the injector device and how the body reacts to it to the current prefilled syringe method. The substudy will last 3 months and will include about 120 participants.

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

Lupus Erythematosus; Systemic Autoimmune Diseases; Connective Tissue Diseases; Immune System Diseases

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that started or worsened in severity after the first dose of study treatment through 28 days after the last dose of study treatment or end of study (EOS) date, whichever comes earlier.

  Up to Week 180

• Number of Participants with Serious Adverse Events (SAEs)

  An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death (a life threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, and is a medically important event.

  Up to Week 180

Secondary Outcomes (22)

• Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response

  Up to Week 180

• Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline who Achieved a Joint-50 Response

  Up to Week 180

• Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Score ≥10 at Baseline who Achieved a CLASI-50, CLASI-70, and CLASI-90 Response

  Up to Week 180

• Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response

  Up to Week 180

• Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate

  Up to Week 156

Study Arms (2)

Litifilimab Low Dose

EXPERIMENTAL

Participants who are receiving background nonbiologic lupus standard of care (SOC) therapy and received litifilimab low dose, subcutaneously (SC), every 4 weeks (Q4W) during the parent Phase 3 studies (i.e. studies 230LE303 \[NCT04895241\] or 230LE304 \[NCT04961567\]) will continue to receive litifilimab low dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 \[NCT04895241\] or 230LE304 \[NCT04961567\]) will be randomized to receive litifilimab low dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose at Week 2.

Drug: Litifilimab; Drug: Litifilimab-matching placebo

Litifilimab High Dose

EXPERIMENTAL

Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab high dose, SC, Q4W during the parent Phase 3 studies (i.e. studies 230LE303 \[NCT04895241\] or 230LE304 \[NCT04961567\]) will continue to receive litifilimab high dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 \[NCT04895241\] or 230LE304 \[NCT04961567\]) will be randomized to receive litifilimab high dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose at Week 2.

Drug: Litifilimab; Drug: Litifilimab-matching placebo

Interventions

Litifilimab DRUG

Administered as specified in the treatment arm.

Also known as: BIIB059

Litifilimab High Dose; Litifilimab Low Dose

Litifilimab-matching placebo DRUG

Administered as specified in the treatment arm.

Also known as: BIIB059

Litifilimab High Dose; Litifilimab Low Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52.

You may not qualify if:

• Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)
• Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period)
• Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose)
• Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.

Sponsors & Collaborators

• Biogen: lead

Study Sites (185)

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, 85037, United States

Location

Wallace Rheumatic Study Center

Beverly Hills, California, 90211, United States

Location

Care Access Research - Huntington Beach

Huntington Beach, California, 92648, United States

Location

Providence Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

Inland Rheumatology Clinical Trials, Inc.

Upland, California, 91786, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Georgetown University Hospital-Medstar

Washington D.C., District of Columbia, 20007-2113, United States

Location

Arthritis & Rheumatic Disease Specialties

Aventura, Florida, 33180, United States

Location

Highlands Research Institute

Avon Park, Florida, 33825, United States

Location

Clinical Research of West Florida - Corporate

Clearwater, Florida, 33765, United States

Location

GNP Research at Mark Jaffe, MD

Cooper City, Florida, 33024, United States

Location

Omega Research Consultants

DeBary, Florida, 32713, United States

Location

Life Clinical Trials

Margate, Florida, 33063, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33606, United States

Location

AdventHealth Medical Group

Tampa, Florida, 33613, United States

Location

Arthritis Center of North Georgia

Gainesville, Georgia, 30501, United States

Location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

AA MRC LLC Ahmed Arif Medical Research Center

Flint, Michigan, 48504, United States

Location

Precision Comprehensive Clinical Research Solutions

Rochester Hills, Michigan, 48307, United States

Location

Saint Louis Rheumatology

St Louis, Missouri, 63119, United States

Location

NYU Langone Brooklyn

Brooklyn, New York, 11220, United States

Location

DJL Clinical Research, PLLC

Charlotte, North Carolina, 28210, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, 44130, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Ramesh C Gupta, MD

Memphis, Tennessee, 38119, United States

Location

Arthritis & Rheumatology Research Institute

Allen, Texas, 75013, United States

Location

Tekton Research - PARENT

Austin, Texas, 78745, United States

Location

Accurate Clinical Research

Baytown, Texas, 77521, United States

Location

Precision Comprehensive Clinical Research Solution

Colleyville, Texas, 76034-5913, United States

Location

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, 76034, United States

Location

Prolato Clinical Research Center

Houston, Texas, 77054, United States

Location

Accurate Clinical Research, Inc.

Humble, Texas, 77338, United States

Location

R and H Clinical Research

Katy, Texas, 77450, United States

Location

Sun Research Institute, LLC

San Antonio, Texas, 78215, United States

Location

Advanced Rheumatology of Houston

The Woodlands, Texas, 77382, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Organizacion Medica de Investigacion (OMI)

CABA, Buenos Aires, C1015ABO, Argentina

Location

Centro de Investigaciones Medicas Mar del Plata

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Policlìnica Red Omip S.A - Ensayos Clinicos GC

Mar del Plata, Buenos Aires, B7600GNY, Argentina

Location

Centro Dermatologico Schejtman

San Miguel, Buenos Aires, B1663, Argentina

Location

Centro Medico Barrio Parque

Buenos Aires, Ciudad Autonoma Buenos Aires, 1425, Argentina

Location

Instituto CAICI

Rosario, Santa Fe Province, S2000PBJ, Argentina

Location

Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Investigaciones Clinicas Tucuman

San Miguel de Tucumán, Tucumán Province, T4000ICL, Argentina

Location

Hospital Italiano de La Plata

Buenos Aires, 17251900, Argentina

Location

Instituto de Investigaciones Clinicas Quilmes

Buenos Aires, 3151878, Argentina

Location

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

Ciudad Autonoma Buenos Aires, 1425, Argentina

Location

STAT Research S.A.

Ciudad Autonoma Buenos Aires, C1013AAB, Argentina

Location

Sanatorio Allende

Córdoba, 5000, Argentina

Location

Instituto de Reumatologia

Mendoza, 5500, Argentina

Location

CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

San Juan, 5400, Argentina

Location

Centre Hospitalier Universitaire de Liege

Liège, 4000, Belgium

Location

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

Fortaleza, Ceará, 60430-372, Brazil

Location

CEDOES - Diagnóstico e Pesquisa

Vitória, Espírito Santo, 29055-450, Brazil

Location

Clínica SER da Bahia

Salvador, Estado de Bahia, 40150-150, Brazil

Location

L2IP - Instituto de Pesquisas Clínicas Ltda.

Brasília, Federal District, 70200-730, Brazil

Location

IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

Santo Ângelo, Mato Grosso, 78020-500, Brazil

Location

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

CMiP - Centro Mineiro de Pesquisa

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

CETI - Centro de Estudos em Terapias Inovadoras Ltda.

Curitiba, Paraná, 80030-110, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

LMK Serviços Médicos S/S Ltda

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90560032, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

Sao Jose Rio Preto, São Paulo, 15090-000, Brazil

Location

Centro Multidisciplinar de Estudos Clínicos - CEMEC

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

São Paulo, São Paulo, 01228-200, Brazil

Location

A2Z Clinical Centro Avancado de Pesquisa Clinica

Valinhos, São Paulo, 13271-130, Brazil

Location

RDSS Ricardo Diaz Scientific Solution

São Paulo, 04037-030, Brazil

Location

MC Artmed OOD

Plovdiv, 4002, Bulgaria

Location

UMHAT "Pulmed" OOD

Plovdiv, 4002, Bulgaria

Location

UMHAT-Plovdiv AD

Plovdiv, 4003, Bulgaria

Location

DCC 1 - Ruse, EOOD

Rousse, 7002, Bulgaria

Location

DCC 'Alexandrovska', EOOD

Sofia, 1431, Bulgaria

Location

DCC Focus 5 - MEOH OOD

Sofia, 1463, Bulgaria

Location

Military Medical Academy - MHAT - Sofia

Sofia, 1606, Bulgaria

Location

UMHAT 'Sv. Ivan Rilski', EAD

Sofia, 1612, Bulgaria

Location

Centro Medico Prosalud

Santiago, 7500000, Chile

Location

CTR Estudios

Santiago, 7500571, Chile

Location

Enroll Spa

Santiago, 7500587, Chile

Location

BioMedica Research Group

Santiago, 7500710, Chile

Location

Clinical Research Chile SpA.

Valdivia, 5090000, Chile

Location

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Dongguan People's Hospital

Dongguan, Guangdong, 523059, China

Location

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510317, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

Zhongshan TCM Hospital

Zhongshan, Guangdong, 528400, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 50000, China

Location

Xiangya Hospital, Central South University

Changsha, Hu'nan, 410008, China

Location

ZhuZhou Central Hospital

Zhuzhou, Hu'nan, 412000, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsushe, 215004, China

Location

Jiujiang No.1 People's Hospital

Jiujiang, Jiangxi, 332000, China

Location

Pingxiang People's Hospital

Pingxiang, Jiangxi, 337055, China

Location

Jilin Province People's Hospital

Changchun, Jilin, 130021, China

Location

Binzhou Medical University Hospital

Binzhou, Shandong, 256603, China

Location

Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch

Shanghai, Shanghai Municipality, 200001, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

IPS Centro Medico Julian Coronel S.A.

Cali, Valle del Cauca Department, 760001, Colombia

Location

Fundacion Cardiomet CEQUIN S.A.S

Armenia, 630004, Colombia

Location

Centro de Investigacion Medico Asistencial S.A.S

Barranquilla, 080020, Colombia

Location

Clínica de la Costa S.A.S

Barranquilla, 080020, Colombia

Location

Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.

Bogotá, 110221, Colombia

Location

Servimed S.A.S.

Bucaramanga, 680003, Colombia

Location

Preventive Care Ltda

Chía, 250001, Colombia

Location

Healthy Medical Center

Zipaquirá, 250252, Colombia

Location

Revmatologie s.r.o.

Brno, 63800, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 77520, Czechia

Location

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, Drôme, 63003, France

Location

NNA Hospital

Athens, Attica, 11521, Greece

Location

Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

Székesfehérvár, Fejér, 8000, Hungary

Location

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Budapest, 1097, Hungary

Location

Bekes Varmegyei Kozponti Korhaz

Gyula, 5700, Hungary

Location

Vital Medical Center

Veszprém, 8200, Hungary

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Tel Aviv Sourasky Medical Center Pt

Tel Aviv, 6423906, Israel

Location

Azienda Ospedaliera San Camillo Forlanini

Roma, 152, Italy

Location

JCHO Chukyo Hospital

Nagoya, Aichi-ken, 457-8510, Japan

Location

Fujita Health University Hospital

Toyoake-shi, Aichi-ken, 470-1192, Japan

Location

NHO Chibahigashi National Hospital

Chiba, Chiba, 260-8712, Japan

Location

KKR Hamanomachi Hospital

Fukuoka, Fukuoka, 810-8539, Japan

Location

NHO Kyushu Medical Center

Fukuoka, Fukuoka, 810-8563, Japan

Location

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, Fukuoka, 807-8556, Japan

Location

Hiroshima University Hospital

Hiroshima, Hiroshima, 734-8551, Japan

Location

Tonan Hospital

Sapporo, Hokkaido, 060-0004, Japan

Location

Japanese Red Cross Society Himeji Hospital

Himeji-shi, Hyōgo, 670-8540, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Kagawa University Hospital

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

NHO Yokohama Medical Center

Yokohama, Kanagawa, 245-8575, Japan

Location

Japanese Red Cross Kumamoto Hospital

Kumamoto, Kumamoto, 861-8520, Japan

Location

Kindai University Hospital

Osakasayama-shi, Osaka, 589-8511, Japan

Location

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo-To, 173-8610, Japan

Location

Toho University Ohashi Medical Center

Meguro-ku, Tokyo-To, 153-8515, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-ku, Tokyo-To, 162-8655, Japan

Location

Clinica de Investigacion en Reumatologia y Obesidad S.C.

Guadalajara, Jalisco, 44650, Mexico

Location

Centro de investigacion medica y reumatologia

Guadalajara, Jalisco, 44950, Mexico

Location

Centro de Investigacion Clínica GRAMEL S.C

Mexico City, Mexico City, 03720, Mexico

Location

Clinstile, S.A. de C.V.

Mexico City, Mexico City, 06700, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran

Mexico City, Mexico City, 14080, Mexico

Location

Consultorio Privado Dr. Miguel Cortes Hernandez

Cuernavaca, Morelos, 62448, Mexico

Location

Centro Peninsular de Investigacion Clinica, SCP

Mérida, Yucatán, 97000, Mexico

Location

Medical Care & Research SA de CV

Mérida, Yucatán, 97070, Mexico

Location

Investigacion y Biomedicina de Chihuahua, S.C.

Chihuahua City, 31000, Mexico

Location

Centro de Investigacion y Atencion Integral Durango CIAID

Durango, 34080, Mexico

Location

Centro de Investigacion Clinica Inmunoreumatologia - ACQ Medic

Lima, LIMA 11, Peru

Location

HMA - Hospital Maria Auxiliadora

Lima, LIMA 29, Peru

Location

Invest Clinicas Sac Inst de Ginecologia y Reproduccion

Lima, LIMA 33, Peru

Location

Mary Mediatrix Medical Center

Lipa City, Batangas, 4217, Philippines

Location

Davao Doctors Hospital

Davao City, Davao Region, 8000, Philippines

Location

University of the Philippines Manila - Philippine General Hospital

Manila, National Capital Region, 1000, Philippines

Location

St. Luke's Medical Center

Quezon City, National Capital Region, 1102, Philippines

Location

Far Eastern University - Dr. Nicanor Reyes Medical Foundation

Quezon City, National Capital Region, 1118, Philippines

Location

Ospital Ng Makati

City of Taguig, 1642, Philippines

Location

The Medical City Iloilo

Iloilo City, 5000, Philippines

Location

Medical Center Manila

Manila, 1000, Philippines

Location

Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty

Bialystok, 15-707, Poland

Location

Szpital Uniwersytecki nr 2 im.dr J. Biziela

Bydgoszcz, 87-100, Poland

Location

Nzoz Bif-Med

Bytom, 41-902, Poland

Location

Pratia MCM Krakow

Krakow, 30-510, Poland

Location

Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.

Malbork, 82-200, Poland

Location

Prywatna Praktyka Lekarska prof Pawel Hrycaj

Poznan, 61-397, Poland

Location

Gabinety Lekarskie Rivermed

Poznan, 61-441, Poland

Location

Przychodnia Care Access Warszawa

Warsaw, 00-719, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, 00-874, Poland

Location

Centro Reumatologico

Caguas, 00725, Puerto Rico

Location

S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L

Brasov, 500283, Romania

Location

S C Delta Health Care SRL

Bucharest, 14142, Romania

Location

Spitalul Clinic Judetean de Urgenta Cluj Napoca

Cluj-Napoca, 400006, Romania

Location

S.C.Centrul Medical Unirea SRL

Iași, 700023, Romania

Location

Institute of Rheumatology

Belgrade, 11000, Serbia

Location

University Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Clinical Center "Bezanijska Kosa "

Belgrade, 11080, Serbia

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 4763, South Korea

Location

Hospital Universitario Marques de Valdecilla

Santander, Castellón, 39008, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Sevilla, 41009, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833401, Taiwan

Location

Guy's Hospital

London, Greater London, SE1 9RT, United Kingdom

Location

Doncaster Royal Infirmary

Doncaster, South Yorkshire, DN2 5LT, United Kingdom

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Autoimmune Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: April 25, 2022
• First Posted: April 29, 2022
• Study Start: June 10, 2022
• Primary Completion (Estimated): March 29, 2030
• Study Completion (Estimated): March 29, 2030
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TW (1); PR (1); CO (8); PL (9); ES (4); FR (1); IL (3); IT (1); HU (4); US (37); PE (3); JP (17); ME (10); PH (8); SE (3); GB (2); RO (4); KR (2); CN (18); CL (5); GR (1); AR (16); BR (16); BE (1); BU (8); CZ (2)