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-2  

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: NCT04961567
• Other study ID #: 230LE304
• Secondary ID: 2023-505696-74
• Status: Recruiting
• Phase: Phase 3
• Start date: July 16, 2021
• Est. completion date: March 5, 2026

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: March 5, 2026
• Est. primary completion date: September 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Participant must be diagnosed with 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-200 (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.
• Participants 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 antibody to hepatitis 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, such as adding intravenous (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
Argentina	Hospital Italiano de La Plata	Buenos Aires	Provincia De Buenos Aires
Argentina	Instituto de Investigaciones Clinicas Quilmes	Buenos Aires	Provincia De Buenos Aires
Argentina	Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada	Ciudad Autonoma Buenos Aires
Argentina	Centro Privado de Medicina Familiar - Mind Out Research	Ciudad Autonoma Buenos Aires
Argentina	Hospital General de Agudos Dr. J. M. Ramos Mejia	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	Organizacion Medica de Investigacion (OMI)	Ciudad Autonoma Buenos Aires
Argentina	STAT Research S.A.	Ciudad Autonoma Buenos Aires
Argentina	APRILLUS Asistencia e Investigacion	Ciudad Autonoma de Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	Centro Medico Barrio Parque	Ciudad Autonoma de Buenos Aires
Argentina	Centro de Investigaciones Medicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	Policlìnica Red Omip S.A - Ensayos Clinicos GC	Mar del Plata	Buenos Aires
Argentina	Instituto de Reumatologia	Mendoza
Argentina	CER San Juan Centro Polivalente de Asistencia e Inv. Clinica	San Juan
Argentina	Centro Dermatologico Schejtman	San Miguel	Buenos Aires
Argentina	Centro de Investigaciones Medicas Tucuman	San Miguel de Tucuman	Tucuman
Argentina	Investigaciones Clinicas Tucuman	San Miguel de Tucumán	Tucuman
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liège	Liege
Canada	The Waterside Clinic	Barrie	Ontario
Canada	Hamilton Health Sciences Corporation	Hamilton	Ontario
Canada	The Ottawa Hospital - General Campus	Ottawa	Ontario
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	The First Hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	The First Affiliated Hospital of Chengdu Medical College	Chengdu	Sichuan
China	Guangdong Second Provincial General Hospital	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Jiujiang No.1 People's Hospital	Jiujiang	Jiujiang
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang
China	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch	Shanghai	Shanghai
China	Ruijin Hospital of Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Wenzhou People's Hospital	Wenzhou	Zhejiang
China	EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Yanbian University Hospital (Yanbian Hospital)	Yanji	Jilin
China	ZhuZhou Central Hospital	ZhuZhou	Hunan
Colombia	Centro de Investigacion Medico Asistencial S.A.S	Barranquilla
Colombia	Clínica de la Costa Ltda.	Barranquilla
Colombia	Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.	Bogotá
Colombia	Servimed S.A.S.	Bucaramanga
Colombia	IPS Centro Medico Julián Coronel S.A.	Cali
Colombia	Preventive Care Ltda	Chia
Colombia	Healthy Medical Center	Zipaquirá
Czechia	Revmatologie s.r.o.	Brno
Czechia	Fakultni nemocnice Olomouc	Olomouc
Germany	Universitaetsmedizin Goettingen	Gottingen	Niedersachsen
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Universitaetsklinikum Koeln	Koeln	Nordrhein Westfalen
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz	Mainz	Rheinland Pfalz
Hungary	Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft.	Budapest
Hungary	Bekes Varmegyei Kozponti Korhaz	Gyula
Hungary	Vita Verum Medical Egeszsegugyi Szolgaltato Bt.	Szekesfehervar
Hungary	Vital Medical Center	Veszprem
Israel	Rambam Health Care Center	Haifa
Israel	Meir Medical Center	Kfar- Sava
Israel	Rabin Medical Center-Beilinson Campus	Petach-Tikva
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)	Brescia
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza	Roma
Italy	Università Campus Bio-Medico di Roma	Roma
Italy	Azienda Ospedaliera San Camillo Forlanini	Rome	Roma
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Italy	Ospedale M. Scarlato	Scafati	Salerno
Japan	Tokyo Medical and Dental University Hospital	Bunkyo-ku	Tokyo-To
Japan	NHO Chibahigashi National Hospital	Chiba-shi	Chiba-Ken
Japan	St. Luke's International Hospital	Chuo-ku	Tokyo-To
Japan	KKR Hamanomachi Hospital	Fukuoka-shi	Fukuoka-Ken
Japan	NHO Kyushu Medical Center	Fukuoka-shi	Fukuoka-Ken
Japan	Japanese Red Cross Society Himeji Hospital	Himeji-shi	Hyogo-Ken
Japan	Hiroshima University Hospital	Hiroshima-shi	Hiroshima-Ken
Japan	Saitama Medical University Hospital	Iruma-gun	Saitama-Ken
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo-To
Japan	NHO Osaka Minami Medical Center	Kawachinagano-shi	Osaka-Fu
Japan	St. Mariana University Hospital	Kawasaki-shi	Kanagawa-ken
Japan	Kagawa University Hospital	Kita-gun	Kagawa-ken
Japan	Hospital of the University of Occupational and Environmental Health, Japan	Kitakyushu-shi	Fukuoka-Ken
Japan	Kobe City Hospital Organization Kobe City Medical Center General Hospital	Kobe-shi	Hyogo-Ken
Japan	Kobe University Hospital	Kobe-shi	Hyogo-Ken
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto-shi	Kumamoto-Ken
Japan	Toho University Ohashi Medical Center	Meguro-ku	Tokyo-To
Japan	JCHO Chukyo Hospital	Nagoya-shi	Aichi-Ken
Japan	Chibaken Saiseikai Narashino Hospital	Narashino-shi	Chiba-Ken
Japan	Tazuke-kofukai Medical Research Institute Kitano Hospital	Osaka-shi	Osaka-Fu
Japan	Kindai University Hospital	Osakasayama-shi	Osaka-Fu
Japan	Toho University Omori Medical Center	Ota-ku	Tokyo-To
Japan	Kitasato University Hospital	Sagamihara-shi	Kanagawa-Ken
Japan	Tonan Hospital	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital	Sendai-shi	Miyagi-Ken
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjuku-ku	Tokyo-To
Japan	Keio University Hospital	Shinjuku-ku	Tokyo-To
Japan	Osaka Medical and Pharmaceutical University Hospital	Takatsuki-shi	Osaka-Fu
Japan	Fujita Health University Hospital	Toyoake-shi	Aichi-Ken
Japan	Yokohama City University Medical Center	Yokohama-shi	Kanagawa-Ken
Netherlands	Amsterdam UMC, Locatie VUMC	Amsterdam
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	UMC Utrecht	Utrecht
Puerto Rico	Centro Reumatologico	Caguas
Romania	S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L	Brasov
Romania	S.C Dental Health Care SRL	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Cluj Napoca	Cluj-Napoca
Romania	S.C.Centrul Medical Unirea SRL	Iasi
Romania	Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava	Suceava
Romania	S.C Centrul Medical Unirea SRL	Targu Mures
Serbia	Clinical Hospital Center Bezanijska kosa	Belgrade
Serbia	Institute of Rheumatology	Belgrade
Serbia	Institute of Rheumatology	Belgrade
Serbia	Institute of Rheumatology	Belgrade
Serbia	University Clinical Center of Serbia	Belgrade
Serbia	Institute of Treatment and Rehabilitation "Niska Banja"	Niska Banja
United Kingdom	Cannock Chase Hospital	Cannock	Staffordshire
United Kingdom	Doncaster Royal Infirmary	Doncaster	South Yorkshire
United Kingdom	Guy's Hospital	London	Greater London
United Kingdom	Whipps Cross University Hospital	London	Greater London
United States	Office of John P. Lavery M.D., PA	Allen	Texas
United States	The Emory Clinic Emory University	Atlanta	Georgia
United States	Tekton Research	Austin	Texas
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	RASF - Clinical Research Center	Boca Raton	Florida
United States	Boston University School of Medicine	Boston	Massachusetts
United States	DJL Clinical Research, PLLC	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Precision Comprehensive Clinical Research Solutions	Colleyville	Texas
United States	STAT Research	Dayton	Ohio
United States	Jefrey Lieberman, M.D., P.C.	Decatur	Georgia
United States	Arthritis & Osteoporosis Associates, PA	Freehold	New Jersey
United States	Arthritis Center of North Georgia	Gainesville	Georgia
United States	University of Florida Gainesville	Gainesville	Florida
United States	Arizona Arthritis & Rheumatology Associates, P.C.	Glendale	Arizona
United States	Piedmont Arthritis Clinic, P.A.	Greenville	South Carolina
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Arthritis and Osteoporosis Associates of New Mexico	Las Cruces	New Mexico
United States	Valerius Medical Group	Los Alamitos	California
United States	SouthWest Rheumatology Research, LLC	Mesquite	Texas
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Saint Louis Rheumatology	Saint Louis	Missouri
United States	Sun Research Institute, LLC	San Antonio	Texas
United States	The University of Texas Health	San Antonio	Texas
United States	Swedish Medical Center	Seattle	Washington
United States	Low Country Rheumatology, PA	Summerville	South Carolina
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	Medvin Clinical Research	Whittier	California
United States	Carolina Arthritis Associates	Wilmington	North Carolina
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  China,  Colombia,  Czechia,  Germany,  Hungary,  Israel,  Italy,  Japan,  Netherlands,  Puerto Rico,  Romania,  Serbia,  United Kingdom, 

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	An 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	An 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 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 up 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 form 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. 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	An 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 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	An 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 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. 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 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	SF-36 determines participants' 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 SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of 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	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	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. Presenteeism (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 scores 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

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