A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic Clinical Trial

— TOPAZ-1  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04895241
• Other study ID #: 230LE303
• Secondary ID: 2023-505695-30
• Status: Recruiting
• Phase: Phase 3
• Start date: May 25, 2021
• Est. completion date: September 12, 2025

Study information

• Verified date: April 2024
• Source: Biogen
• Contact: US Biogen Clinical Trial Center
• Phone: 866-633-4636
• Email: clinicaltrials[@]biogen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is:

• How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the 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 Patient Global Assessment - Visual Analog Scale (PGA-VAS).

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 SLE have on the quality of life of participants using a group of questionnaires.

The study will be done as follows:

• After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine.

• All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications.

• Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.

• There will be a follow-up safety period that lasts up to 24 weeks.

• In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: September 12, 2025
• Est. primary completion date: March 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Participant must be diagnosed with systemic lupus erythematosus (SLE) at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria for SLE at screening by a qualified physician.

• Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score = 6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated).

• Participant has a modified clinical SLEDAI-2K score = 4 (excluding anti-dsDNA, low complement component 3 (C3) and/or complement component 4 (C4), alopecia, fever, lupus-related headache, and organic brain syndrome) at Screening (adjudicated) and randomization.

• Participant has BILAG-2004 grade A in = 1 organ system or BILAG-2004 grade B in = 2 organ systems at Screening (adjudicated) and randomization.

• Participant must be treated with one of the following background nonbiologic lupus SOC therapies, initiated = 12 weeks prior to Screening and at stable dose = 4 weeks prior to randomization:

1. Antimalarials as stand-alone treatment

2. Antimalarial treatment in combination with OCS and/or a single immunosuppressant

3. Treatment with OCS and/or a single immunosuppressant

Key Exclusion Criteria:

• History of or positive test result for human immunodeficiency virus (HIV).

• Current hepatitis C infection (defined as positive hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid [RNA]).

• Current hepatitis B infection (defined as positive for antibody to hepatitis B surface antigen (HBsAg) and/or positive for total hepatitis antibody to B core antigen [anti-HBc] with positive reflex HBV DNA).

• History of severe herpes infection.

• Presence of uncontrolled or New York Heart Association class III or IV congestive heart failure.

• Active severe lupus nephritis where, in the opinion of the Investigator, protocol-specified SOC is insufficient and use of a more aggressive therapeutic approach is indicated, such as adding IV cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol is indicated; or urine protein-creatinine ratio > 2.0 or severe chronic kidney disease (estimated glomerular filtration rate < 30 milliliters per minute per 1.73 meter square [mL/min/1.73 m^2]) calculated using the abbreviated modification of diet in renal disease equation.

• Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE skin lupus manifestation or drug-induced lupus.

• History or current diagnosis of a clinically significant non-SLE-related vasculitis syndrome.

• Active neuropsychiatric SLE.

• Use of oral prednisone (or equivalent) above 20 mg/day.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• Litifilimab
Administered as specified in the treatment arm.
• Placebo
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Footscray Hospital	Footscray	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Brazil	Santa Casa de Misericórdia de Belo Horizonte	Belo Horizonte	Minas Gerais
Brazil	L2IP - Instituto de Pesquisas Clínicas Ltda.	Brasilia	Distrito Federal
Brazil	Oncovida - Centro de Onco-Hematologia de Mato Grosso	Cuiabá	Mato Grosso
Brazil	CETI - Centro de Estudos em Terapias Inovadoras Ltda.	Curitiba	Paraná
Brazil	HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará	Fortaleza	Ceará
Brazil	CMiP - Centro Mineiro de Pesquisa	Juiz de Fora	Minas Gerais
Brazil	Hospital Bruno Born	Lajeado	Rio Grande Do Sul
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	LMK Serviços Médicos S/S Ltda	Porto Alegre	Rio Grande Do Sul
Brazil	Clínica SER da Bahia	Salvador	Bahia
Brazil	Centro Multidisciplinar de Estudos Clínicos - CEMEC	São Bernardo do Campo	Sao Paulo
Brazil	Fundação Faculdade Regional de Medicina de São José do Rio Preto	Sao Jose Rio Preto	Sao Paulo
Brazil	CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos	São Paulo	Sao Paulo
Brazil	CEDOES - Diagnóstico e Pesquisa	Vitória	Espírito Santo
Bulgaria	DCC 'Sv. Georgi', EOOD	Plovdiv
Bulgaria	UMHAT "Pulmed" OOD	Plovdiv
Bulgaria	UMHAT-Plovdiv AD	Plovdiv
Bulgaria	DCC 1 - Ruse, EOOD	Ruse
Bulgaria	DCC 'Alexandrovska', EOOD	Sofia
Bulgaria	Medical Center Hera EOOD	Sofia
Bulgaria	Military Medical Academy - MHAT - Sofia	Sofia
Bulgaria	UMHAT 'Sv. Ivan Rilski', EAD	Sofia
Bulgaria	UMHAT 'Sv. Ivan Rilski', EAD	Sofia
Chile	Clinica Alemana de Osorno	Osorno
Chile	BioMedica Research Group	Santiago
Chile	Centro Medico Prosalud	Santiago
Chile	CTR Estudios	Santiago
Chile	Enroll Spa	Santiago
Chile	Interin	Santiago
Chile	SOMEAL	Santiago
France	Groupe Hospitalier Pellegrin - Hôpital Pellegrin	Bordeaux	Gironde
France	CHU Clermont Ferrand - Hopital Gabriel Montpied	Clermont-Ferrand cedex 1	Puy De Dome
France	Hopital Lapeyronie	Montpellier Cedex 5	Herault
Greece	General Hospital of Athens Laiko	Athens
Greece	NNA Hospita;	Athens
Greece	University General Hospital 'Attikon'	Athens
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do
Mexico	Investigacion y Biomedicina de Chihuahua, S.C.	Chihuahua
Mexico	Clinstile, S.A. de C.V.	Ciudad de México	Distrito Federal
Mexico	Consultorio Privado Dr. Miguel Cortes Hernandez	Cuernavaca	Morelos
Mexico	Centro de Investigacion y Atencion Integral Durango CIAID	Durango
Mexico	Centro de investigacion medica y reumatologia	Guadalajara	Jalisco
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S.C.	Guadalajara	Jalisco
Mexico	Diseno y Planeacion en Investigacion Medica S.C.	Guadalajara	Jalisco
Mexico	Centro Peninsular de Investigacion Clinica, SCP	Merida	Yucatán
Mexico	Medical Care & Research SA de CV	Merida	Yucatán
Mexico	Centro de Investigacion Clínica GRAMEL S.C	Mexico	Distrito Federal
Mexico	Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey	Nuevo León
Philippines	Davao Doctors Hospital	Davao City
Philippines	The Medical City Iloilo	Iloilo
Philippines	Mary Mediatrix Medical Center	Lipa City
Philippines	The Medical City Clark	Mabalacat, Pampanga
Philippines	Manila Doctors Hospital	Manila
Philippines	Medical Center Manila	Manila
Philippines	Philippine General Hospital	Manila
Philippines	St. Luke's Medical Center	Quenzon City
Philippines	Far Eastern University - Dr. Nicanor Reyes Medical Foundation	Quezon City, Metro Manila
Poland	Nova Reuma Domyslawska i Rusilowicz, Spólka Partnerska Lekarza Reumatologa i Fizjoterapeuty	Bialystok
Poland	Centrum Medyczne Intercor Sp. z o.o	Bydgoszcz
Poland	Szpital Uniwersytecki nr 2 im.dr J. Biziela	Bydgoszcz
Poland	Nzoz Bif-Med	Bytom
Poland	Centrum Medyczne All-Med	Krakow
Poland	Centrum Medyczne Plejady	Krakow
Poland	Pratia MCM Krakow	Krakow
Poland	Reumed Spolka z o.o.	Lublin
Poland	Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.	Malbork
Poland	MICS Centrum Medyczne Warszawa	Warszawa
Poland	Niepubliczny Zaklad Opieki Zdrowotnej 'Biogenes' Sp. z o.o.	Wroclaw
Russian Federation	LLC 'Medical Center' Revma-Med '	Kemerovo
Russian Federation	Olla-Med, Llc	Moscow
Russian Federation	SBIH 'Orenburg Regional Clinical Hospital'	Orenburg
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario San Cecilio	Granada
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Quironsalud Infanta Luisa	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario Dr. Peset	Valencia
Sweden	Universitetssjukhuset Orebro	Örebro
Sweden	Karolinska Universitetssjukhuset Solna	Stockholm
Sweden	Akademiska Sjukhuset	Uppasala
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital,Linkou	Taoyuan County
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Arthritis & Rheumatic Disease Specialties	Aventura	Florida
United States	Wallace Rheumatic Study Center	Beverly Hills	California
United States	Joseph S. and Diane H. Steinberg Ambulatory Care Center	Brooklyn	New York
United States	Joint and Muscle Research Institute	Charlotte	North Carolina
United States	Clinical Research of West Florida - Corporate	Clearwater	Florida
United States	Precision Comprehensive Clinical Research Solution	Colleyville	Texas
United States	Believe Clinical Trials	Coral Springs	Florida
United States	Believe Clinical Trials	Coral Springs	Florida
United States	Omega Research Consultants	DeBary	Florida
United States	AA MRC LLC Ahmed Arif Medical Research Center	Flint	Michigan
United States	Centre for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida
United States	Medication Management, LLC	Greensboro	North Carolina
United States	GNP Research at Mark Jaffe, MD	Hollywood	Florida
United States	Pioneer Research Solutions, Inc.	Houston	Texas
United States	Accurate Clinical Research, Inc.	Humble	Texas
United States	University of Southern California	Los Angeles	California
United States	Life Clinical Trials	Margate	Florida
United States	Ramesh C Gupta, MD	Memphis	Tennessee
United States	Charisma Medical and Research Center	Miami Lakes	Florida
United States	Paramount Medical Research & Consulting, LLC	Middleburg Heights	Ohio
United States	Providence Facey Medical Foundation	Mission Hills	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Northwell Health Center for Advanced Medicine	New Hyde Park	New York
United States	Rheumatology Associates of Central Florida	Orlando	Florida
United States	University of Rochester Medical Center	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of California San Diego School of Medicine	San Diego	California
United States	University of Washington	Seattle	Washington
United States	Accurate Clinical Research	Stafford	Texas
United States	SUNY Upstate Medical Center	Syracuse	New York
United States	AdventHealth Medical Group	Tampa	Florida
United States	Advanced Rheumatology of Houston	The Woodlands	Texas
United States	Inland Rheumatology Clinical Trials, Inc.	Upland	California
United States	Georgetown University Hospital-Medstar	Washington	District of Columbia
United States	CLS Research Ctr, PLLC	Webster	Texas
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Bulgaria,  Chile,  France,  Greece,  Korea, Republic of,  Mexico,  Philippines,  Poland,  Russian Federation,  Spain,  Sweden,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52	SRI-4 response is a composite endpoint defined by the following criteria: Reduction from baseline of =4 points in systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K).; No new organ system affected, as defined by no new organ system with British isles lupus assessment group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline.; No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point Physician's Global Assessment (PGA) - Visual Analog Scale (VAS).; No violation to protocol-specified medication rules.	Week 52
Secondary	Percentage of Participants Who Achieved an SRI-4 Response at Week 24	SRI-4 response is a composite endpoint defined by the following criteria: Reduction from baseline of =4 points in SLEDAI-2K.; No new organ system affected, as defined by no new organ system with British isles lupus assessment group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline.; No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA -VAS.; No violation to protocol-specified medication rules.	Week 24
Secondary	Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52	Joint-50 response is 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.	Week 52
Secondary	Percentage of Participants with OCS =10 milligrams per day (mg/day) at Baseline Who Have OCS Reduction to =7.5 mg/day at Week 40, Which Is Sustained Through Week 52 with No Disease Worsening from Week 40 to Week 52	No worsening of the disease is defined as no new BILAG-2004 grade A or less than 2 new BILAG-2004 grade B since the last visit during the Week 40 to Week 52.	Week 40 to Week 52
Secondary	Percentage of Participants with a CLASI-A score =10 at Baseline Who Achieved a 50% Improvement From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-50) Response at Week 16	Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement from baseline in CLASI-A.	Week 16
Secondary	Annualized Flare Rate Through Week 52	Annualized flare rate will be calculated as the total number of flares divided by the flare exposure time in days, and the ratio multiplied by 365.25.	Up to Week 52
Secondary	Change from Baseline in Physician's Global Assessment (PGA) Visual Analog Scale (VAS) Score by Visit	The PGA is an Investigator-administered assessment used to quantify disease activity and is measured using an anchored VAS. The PGA asks the Investigator to assess the participant's current disease activity from a score of 0 (none) to 3 (severe), with the assessment made relative to the most severe state of SLE.	Up to Week 52
Secondary	Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit	The BILAG disease activity index evaluates SLE activity in number of organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows, BILAG A: severe disease activity; BILAG B: moderate disease activity; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved. BICLA is a composite endpoint defined as BILAG-2004 improvement, defined as all BILAG-2004 grade A at Baseline improved to grade B, C, or D, and all BILAG-2004 grade B at baseline improved to grade C or D, no BILAG-2004 worsening in other BILAG-2004 organ systems such that there are no new BILAG-2004 grade A or greater than 1 new BILAG-2004 grade B, no worsening in the SLEDAI-2K total score compared with Baseline, no worsening from Baseline in lupus disease activity defined by < 0.3-point increase on 3-point PGA-VAS and no violation to protocol-specified medication rules.	Up to Week 52
Secondary	Time to Onset of SRI-4 Response Sustained Through Week 52	SRI-4 response is a composite endpoint defined by the following criteria: Reduction from baseline of =4 points in SLEDAI-2K.; No new organ system affected, as defined by no new organ system with British isles lupus assessment group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline.; No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA -VAS.; No violation to protocol-specified medication rules.	Up to Week 52
Secondary	Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit	SRI-4 response is a composite endpoint defined by the following criteria: Reduction from baseline of =4 points in SLEDAI-2K.; No new organ system affected, as defined by no new organ system with British isles lupus assessment group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with Baseline.; No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA -VAS.; No violation to protocol-specified medication rules. The SRI-5 and SRI-6 are computed with a minimal five-point or six-point improvement in SLEDAI-2K being required, respectively.	Up to Week 52
Secondary	Percentage of Participants with Joint-50 Response by Visit	Joint-50 response is 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.	Up to Week 52
Secondary	Percentage of Participants with Baseline CLASI-A Score =10 Who Achieved a CLASI-20, -50, -70, or -90 Response by Visit	Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-20, -50, -70 and -90 represent 20%, 50%, 70% or 90% improvement from baseline in CLASI-A score, respectively.	Up to Week 52
Secondary	Percentage of Participants with Baseline CLASI-A Score =10 Who Achieved a CLASI-A Score of = 1 by Visit	Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-A =1 represent the absolute score =1 in CLASI-A by visit.	Up to Week 52
Secondary	Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit	BILAG-2004 severe flare is defined as an A score for items recorded as worse or new. BILAG-2004 is evaluated by scoring each item of a list of signs and symptoms given as 4 = new; 3 = worse; 2 = same; 1 = improving; 0 = not present; and ND = not done.	Up to Week 52
Secondary	Time to First Severe Flare as defined by the Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI)	SFI severe flare is defined any of the following: change in SLEDAI instrument score to >12; or new or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets <60,000 per milliliter (/mL); or hemolytic anemia with hemoglobin <7 grams per deciliter (g/dL) or decrease in hemoglobin >3 g/dL and requiring: doubling prednisone dose; or increase to >0.5 milligrams per kilogram per day (mg/kg/day) or hospitalization; or increase in prednisone dose to >0.5 mg/kg/day; or new requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity; or hospitalization for SLE activity; or increase in PGA score to >2.5.	Up to Week 52
Secondary	Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)	LLDAS is a composite endpoint defined as: SLEDAI-2K score = 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and; No new features of lupus disease activity compared with the previous assessment; and; Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) PGA = 1; and; Current prednisone (or equivalent) dose = 7.5 mg/day; and; Standard maintenance doses of immunosuppressive drugs and approved biological agents.	Up to Week 52
Secondary	Percentage of Participants With Sustained LLDAS as Defined by the Number of Participants With = 3, = 5, and = 7 Consecutive Visits in LLDAS up to and Including Week 52	LLDAS is a composite endpoint defined as: SLEDAI-2K score = 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and; No new features of lupus disease activity compared with the previous assessment; and; SELENA-SLEDAI PGA = 1; and; Current prednisone (or equivalent) dose = 7.5 mg/day; and; Standard maintenance doses of immunosuppressive drugs and approved biological agents.	Up to Week 52
Secondary	Percentage of Participants who Achieved LLDAS at Week 52	LLDAS is a composite endpoint defined as: SLEDAI-2K score = 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and; No new features of lupus disease activity compared with the previous assessment; and; SELENA-SLEDAI PGA = 1; and; Current prednisone (or equivalent) dose = 7.5 mg/day; and; Standard maintenance doses of immunosuppressive drugs and approved biological agents.	Week 52
Secondary	Percentage of Participants With Baseline OCS =10 mg/day Who Achieved =7.5 mg/day at Week 52		Week 52
Secondary	Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score	The LupusQoL is a participant-reported, lupus-specific, Health-Related Quality-of-Life Questionnaire (HRQoL) consisting of 34 items grouped in 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4 = never, 3 = occasionally, 2 = a good bit of the time, 1 = most of the time, and 0 = all the time. A LupusQoL score for each domain will be reported on a 0 to 100 scale, with greater values indicating better HRQoL.	Up to Week 52
Secondary	Change From Baseline in Short Form Health Survey-36 (SF-36) Score	The SF-36 determines participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement.	Up to Week 52
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score	The FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in the 5 broad categories: physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns. The level of fatigue is measured by questions assessed on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The responses for each item are added to obtain a total score which ranges from 0 to 52, with a higher score indicating less fatigue.	Up to Week 52
Secondary	Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score	The PHQ-9 is a participant-administered HRQoL questionnaire to screen for the presence and severity of depression. The PHQ-9 is a participant-reported outcome (PRO) that is used to measure depression in adults. It contains 9 questions. The PHQ-9 yields an overall severity score that can range from 0 to 27 with the following severity scores: 0-4 = none; 5-9 = mild; 10-14 = moderate; 15-19 = moderate-to-severe; and 20-27 = severe.	Up to Week 52
Secondary	Change From Baseline in Work Productivity and Activity Impairment (WPAI): Lupus Score	WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. Each score ranges from 0 to 100, with higher numbers indicating greater impairment and less productivity	Up to Week 52
Secondary	Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. 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. An SAE is any untoward medical occurrence that at any dose results in death (a life-threatening event), in the view of the investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a birth defect, or is a medically important event.	Up to Week 52
Secondary	Number of Participants with Antibodies to Litifilimab		Up to Week 52

External Links

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