Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05352919
Registration number
NCT05352919
Ethics application status
Date submitted
25/04/2022
Date registered
29/04/2022
Date last updated
15/09/2023
Titles & IDs
Public title
A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus
Query!
Scientific title
A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus
Query!
Secondary ID [1]
0
0
2021-006378-22
Query!
Secondary ID [2]
0
0
230LE306
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
EMERALD
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus (SLE)
0
0
Query!
Condition category
Condition code
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Litifilimab
Treatment: Drugs - Litifilimab-matching placebo
Experimental: Litifilimab Low Dose - 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.
Experimental: Litifilimab High Dose - 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.
Treatment: Drugs: Litifilimab
Administered as specified in the treatment arm.
Treatment: Drugs: Litifilimab-matching placebo
Administered as specified in the treatment arm.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to Week 180
Query!
Primary outcome [2]
0
0
Number of Participants with Serious Adverse Events (SAEs)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to Week 180
Query!
Secondary outcome [1]
0
0
Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response
Query!
Assessment method [1]
0
0
SRI-4 is a composite endpoint defined as the following:
A reduction from baseline of =4 points in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score.
No new organ system affected, as defined by no new British Isles Lupus Activity Group-2004 (BILAG-2004 grade A) and no more than 1 new BILAG 2004 grade B versus previous visit.
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 of protocol-specified medication rules
Query!
Timepoint [1]
0
0
Up to Week 180
Query!
Secondary outcome [2]
0
0
Percentage of Participants who Achieved a Joint-50 Response
Query!
Assessment method [2]
0
0
Joint-50 response is a 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.
Query!
Timepoint [2]
0
0
Up to Week 180
Query!
Secondary outcome [3]
0
0
Percentage of Participants who Achieved Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50, CLASI-70, and CLASI-90 Response
Query!
Assessment method [3]
0
0
CLASI score is used to evaluate lupus skin manifestations. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Scores for each area are assigned based on the most severe lesion within the area of interest. 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. CLASI-70 is 70% of improvement from baseline in CLASI-A and CLASI-90 is 90% of improvement from baseline in CLASI-A.
Query!
Timepoint [3]
0
0
Up to Week 180
Query!
Secondary outcome [4]
0
0
Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response
Query!
Assessment method [4]
0
0
BICLA is a composite endpoint defined as the following:
BILAG-2004 improvement, defined as all of BILAG-2004 Grade A at Baseline improved to B, C, or D and all of BILAG-2004 Grade B at Baseline improved to 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 to baseline.
No worsening from baseline in lupus disease activity defined by a <0.3-point increase on a 3-point PGA VAS.
No violation of protocol-specified medication rules.
Query!
Timepoint [4]
0
0
Up to Week 180
Query!
Secondary outcome [5]
0
0
Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate
Query!
Assessment method [5]
0
0
A severe flare is defined as any of the following:
Change in SLEDAI instrument score to >12
New or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets <60,000/mL, or hemolytic anemia with hemoglobin <7 grams per deciliter (g/dL) or decrease in hemoglobin >3 g/dL and requiring: doubling prednisone dose, increase to >0.5 milligrams per kilograms per day (mg/kg/day) or hospitalization
Increase in prednisone dose to >0.5 mg/kg/day
New requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity
Hospitalization for SLE activity
Increase in PGA score to >2.5
Query!
Timepoint [5]
0
0
Up to Week 156
Query!
Secondary outcome [6]
0
0
Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
Query!
Assessment method [6]
0
0
LLDAS is a composite endpoint defined as the following:
i. SLEDAI-2K score = 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA = 1; and iv. Current prednisone (or equivalent) dose = 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents.
"No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol.
Query!
Timepoint [6]
0
0
Up to Week 180
Query!
Secondary outcome [7]
0
0
Percentage of Participants With Sustained LLDAS
Query!
Assessment method [7]
0
0
LLDAS is a composite endpoint defined as the following:
i. SLEDAI-2K score = 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA = 1; and iv. Current prednisone (or equivalent) dose = 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents.
"No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol.
Query!
Timepoint [7]
0
0
Up to Week 180
Query!
Secondary outcome [8]
0
0
Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS
Query!
Assessment method [8]
0
0
LLDAS is a composite endpoint defined as the following:
i. SLEDAI-2K score = 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA = 1; and iv. Current prednisone (or equivalent) dose = 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents.
"No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol.
Query!
Timepoint [8]
0
0
Up to Week 180
Query!
Secondary outcome [9]
0
0
Annual Change From Baseline Value From the Parent Phase 3 Studies in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) Score
Query!
Assessment method [9]
0
0
SDI score is used to assess the accumulated damage in participants with SLE. It assess 12 organ systems and records damage in participants with lupus, regardless of its cause. Damage could be due to previous disease activity, medication, or intercurrent illness (such as surgery or cancer). To distinguish between active inflammation and damage, an item must be present for at least 6 months. It is assumed that persistent inflammation (for at least 6 months) would result in tissue injury and hence damage. SDI is evaluated on a scale 0-47 with higher score indicating higher damage.
Query!
Timepoint [9]
0
0
Up to Week 156
Query!
Secondary outcome [10]
0
0
Cumulative Exposure to OCS Over Time
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Up to Week 156
Query!
Secondary outcome [11]
0
0
Percentage of Participants With OCS =7.5 mg
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Up to Week 156
Query!
Secondary outcome [12]
0
0
Percentage of Participants With OCS =5 mg
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
Up to Week 156
Query!
Secondary outcome [13]
0
0
Change From Baseline in Lupus-Specific Health-Related Quality-Of-Life (LupusQoL) Score
Query!
Assessment method [13]
0
0
The LupusQoL is a participant-reported, lupus-specific, HRQoL questionnaire 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.
Query!
Timepoint [13]
0
0
Up to Week 156
Query!
Secondary outcome [14]
0
0
Change From Baseline in Short Form Health Survey-36 (SF-36) (Acute Version) Score
Query!
Assessment method [14]
0
0
The SF-36 is a 36-item scale which assesses HRQoL in 8 domains: limitations in physical activities due to health problems, limitations in social activities due to physical or emotional problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to emotional problems, vitality (energy and fatigue), general health perceptions. The SF-36 (Acute Version) form asks for participants to reply to questions (items) according to how they have felt over a specifically defined period of time. 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 where higher scores indicate best health. Scores on each item are summed and averaged (range: 0=worse health to 100=best possible health).
Query!
Timepoint [14]
0
0
Up to Week 156
Query!
Secondary outcome [15]
0
0
Change From Baseline in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
Query!
Assessment method [15]
0
0
The EQ-5D is a standardized generic measure of health status developed by the European Quality of Life Group. This study uses the EQ-5D-3L version of the instrument. This instrument consists of 2 sections. The first section comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. All dimensions are measured on a 3-point scale, 1: No problems; 2: Some problems; 3: Extreme problems. The second section comprises the Visual Analogue Scale, which records the respondent's self-rated health on a vertical scale ranging from 0 to 100, lower scores indicate the worst possible health state.
Query!
Timepoint [15]
0
0
Up to Week 156
Query!
Secondary outcome [16]
0
0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score
Query!
Assessment method [16]
0
0
The FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in 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.
Query!
Timepoint [16]
0
0
Up to Week 156
Query!
Secondary outcome [17]
0
0
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
Query!
Assessment method [17]
0
0
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, with a 2 week recall period. 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.
Query!
Timepoint [17]
0
0
Up to Week 156
Query!
Secondary outcome [18]
0
0
Change From Baseline in Work Productivity and Activity Impairment (WPAI):Lupus Score
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
Up to Week 156
Query!
Secondary outcome [19]
0
0
Change from Baseline in Patient Global Assessment (PtGA) Score
Query!
Assessment method [19]
0
0
The PtGA is participant-administered, single-item question evaluating the impact of health and illness, with responses ranging from very poor to very well on a 100 mm VAS. The participant will consider the previous week when addressing this question.
Query!
Timepoint [19]
0
0
Up to Week 156
Query!
Secondary outcome [20]
0
0
Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters
Query!
Assessment method [20]
0
0
Standard laboratory parameters will include hematology, blood chemistry, urinalysis, and coagulation.
Query!
Timepoint [20]
0
0
Up to Week 180
Query!
Secondary outcome [21]
0
0
Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECG) Results
Query!
Assessment method [21]
0
0
Query!
Timepoint [21]
0
0
Up to Week 156
Query!
Secondary outcome [22]
0
0
Number of Participants with Antibodies to Litifilimab
Query!
Assessment method [22]
0
0
Query!
Timepoint [22]
0
0
Up to Week 180
Query!
Eligibility
Key inclusion criteria
Key
- 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
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- 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
NOTE: Other inclusion/exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/06/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
13/03/2029
Query!
Actual
Query!
Sample size
Target
864
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
Box Hill Hospital - Caulfield
Query!
Recruitment hospital [3]
0
0
Footscray Hospital - Footscray
Query!
Recruitment hospital [4]
0
0
Fiona Stanley Hospital - Murdoch
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
3162 - Caulfield
Query!
Recruitment postcode(s) [3]
0
0
3011 - Footscray
Query!
Recruitment postcode(s) [4]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Michigan
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New Jersey
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Mexico
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Pennsylvania
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
South Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Tennessee
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Washington
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Buenos Aires
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Tucuman
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Ciudad Autonoma Buenos Aires
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Mendoza
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
San Juan
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Leuven
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Liege
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Bahia
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Ceará
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Distrito Federal
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Espírito Santo
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Mato Grosso
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Minas Gerais
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Paraná
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Rio Grande Do Sul
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Sao Paulo
Query!
Country [38]
0
0
Bulgaria
Query!
State/province [38]
0
0
Plovdiv
Query!
Country [39]
0
0
Bulgaria
Query!
State/province [39]
0
0
Ruse
Query!
Country [40]
0
0
Bulgaria
Query!
State/province [40]
0
0
Sofia
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Ontario
Query!
Country [42]
0
0
Chile
Query!
State/province [42]
0
0
Osorno
Query!
Country [43]
0
0
Chile
Query!
State/province [43]
0
0
Santiago
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Beijing
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Guangdong
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Hainan
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Hubei
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Hunan
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Jiangxi
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Jilin
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Shandong
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Shanghai
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Sichuan
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Tianjin
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Xinjiang
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Zhejiang
Query!
Country [57]
0
0
Colombia
Query!
State/province [57]
0
0
Barranquilla
Query!
Country [58]
0
0
Colombia
Query!
State/province [58]
0
0
Bogotá
Query!
Country [59]
0
0
Colombia
Query!
State/province [59]
0
0
Bucaramanga
Query!
Country [60]
0
0
Colombia
Query!
State/province [60]
0
0
Chia
Query!
Country [61]
0
0
Colombia
Query!
State/province [61]
0
0
Zipaquirá
Query!
Country [62]
0
0
Czechia
Query!
State/province [62]
0
0
Brno
Query!
Country [63]
0
0
Czechia
Query!
State/province [63]
0
0
Olomouc
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Gironde
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Herault
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Puy De Dome
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Paris
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Niedersachsen
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Nordrhein Westfalen
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Rheinland Pfalz
Query!
Country [71]
0
0
Greece
Query!
State/province [71]
0
0
Athens
Query!
Country [72]
0
0
Hungary
Query!
State/province [72]
0
0
Budapest
Query!
Country [73]
0
0
Hungary
Query!
State/province [73]
0
0
Gyula
Query!
Country [74]
0
0
Hungary
Query!
State/province [74]
0
0
Szekesfehervar
Query!
Country [75]
0
0
Hungary
Query!
State/province [75]
0
0
Veszprem
Query!
Country [76]
0
0
Israel
Query!
State/province [76]
0
0
Haifa
Query!
Country [77]
0
0
Israel
Query!
State/province [77]
0
0
Kfar- Sava
Query!
Country [78]
0
0
Israel
Query!
State/province [78]
0
0
Petach-Tikva
Query!
Country [79]
0
0
Israel
Query!
State/province [79]
0
0
Ramat Gan
Query!
Country [80]
0
0
Israel
Query!
State/province [80]
0
0
Tel Aviv
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Milano
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Salerno
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Brescia
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Padova
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Pisa
Query!
Country [86]
0
0
Italy
Query!
State/province [86]
0
0
Roma
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Aichi-Ken
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Chiba-Ken
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Fukuoka-Ken
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Hiroshima-Ken
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Hokkaido
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Hyogo-Ken
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Hyogo-ken
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Kagawa-Ken
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Kanagawa-Ken
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Kumamoto-Ken
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Miyagi-Ken
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Nagasaki-Ken
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Osaka-Fu
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Saitama-Ken
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Tokyo-To
Query!
Country [102]
0
0
Korea, Republic of
Query!
State/province [102]
0
0
Gyeonggi-do
Query!
Country [103]
0
0
Korea, Republic of
Query!
State/province [103]
0
0
Busan
Query!
Country [104]
0
0
Korea, Republic of
Query!
State/province [104]
0
0
Incheon
Query!
Country [105]
0
0
Korea, Republic of
Query!
State/province [105]
0
0
Seoul
Query!
Country [106]
0
0
Mexico
Query!
State/province [106]
0
0
Distrito Federal
Query!
Country [107]
0
0
Mexico
Query!
State/province [107]
0
0
Jalisco
Query!
Country [108]
0
0
Mexico
Query!
State/province [108]
0
0
Morelos
Query!
Country [109]
0
0
Mexico
Query!
State/province [109]
0
0
Nuevo León
Query!
Country [110]
0
0
Mexico
Query!
State/province [110]
0
0
Yucatán
Query!
Country [111]
0
0
Mexico
Query!
State/province [111]
0
0
Chihuahua
Query!
Country [112]
0
0
Mexico
Query!
State/province [112]
0
0
Durango
Query!
Country [113]
0
0
Netherlands
Query!
State/province [113]
0
0
Amsterdam
Query!
Country [114]
0
0
Netherlands
Query!
State/province [114]
0
0
Groningen
Query!
Country [115]
0
0
Netherlands
Query!
State/province [115]
0
0
Maastricht
Query!
Country [116]
0
0
Netherlands
Query!
State/province [116]
0
0
Utrecht
Query!
Country [117]
0
0
Peru
Query!
State/province [117]
0
0
Arequipa
Query!
Country [118]
0
0
Peru
Query!
State/province [118]
0
0
Lima
Query!
Country [119]
0
0
Philippines
Query!
State/province [119]
0
0
Davao City
Query!
Country [120]
0
0
Philippines
Query!
State/province [120]
0
0
Lipa City
Query!
Country [121]
0
0
Philippines
Query!
State/province [121]
0
0
Manila
Query!
Country [122]
0
0
Philippines
Query!
State/province [122]
0
0
Quezon City
Query!
Country [123]
0
0
Poland
Query!
State/province [123]
0
0
Bialystok
Query!
Country [124]
0
0
Poland
Query!
State/province [124]
0
0
Bydgoszcz
Query!
Country [125]
0
0
Poland
Query!
State/province [125]
0
0
Bytom
Query!
Country [126]
0
0
Poland
Query!
State/province [126]
0
0
Elblag
Query!
Country [127]
0
0
Poland
Query!
State/province [127]
0
0
Krakow
Query!
Country [128]
0
0
Poland
Query!
State/province [128]
0
0
Kraków
Query!
Country [129]
0
0
Poland
Query!
State/province [129]
0
0
Lublin
Query!
Country [130]
0
0
Poland
Query!
State/province [130]
0
0
Szczecin
Query!
Country [131]
0
0
Poland
Query!
State/province [131]
0
0
Warszawa
Query!
Country [132]
0
0
Poland
Query!
State/province [132]
0
0
Wroclaw
Query!
Country [133]
0
0
Puerto Rico
Query!
State/province [133]
0
0
Caguas
Query!
Country [134]
0
0
Romania
Query!
State/province [134]
0
0
Brasov
Query!
Country [135]
0
0
Romania
Query!
State/province [135]
0
0
Bucuresti
Query!
Country [136]
0
0
Romania
Query!
State/province [136]
0
0
Cluj-Napoca
Query!
Country [137]
0
0
Romania
Query!
State/province [137]
0
0
Iasi
Query!
Country [138]
0
0
Romania
Query!
State/province [138]
0
0
Targu Mures
Query!
Country [139]
0
0
Russian Federation
Query!
State/province [139]
0
0
Kemerovo
Query!
Country [140]
0
0
Russian Federation
Query!
State/province [140]
0
0
Moscow
Query!
Country [141]
0
0
Russian Federation
Query!
State/province [141]
0
0
Orenburg
Query!
Country [142]
0
0
Russian Federation
Query!
State/province [142]
0
0
Saint Petersburg
Query!
Country [143]
0
0
Serbia
Query!
State/province [143]
0
0
Belgrade
Query!
Country [144]
0
0
Serbia
Query!
State/province [144]
0
0
Niska Banja
Query!
Country [145]
0
0
Spain
Query!
State/province [145]
0
0
Cantabria
Query!
Country [146]
0
0
Spain
Query!
State/province [146]
0
0
Barcelona
Query!
Country [147]
0
0
Spain
Query!
State/province [147]
0
0
Granada
Query!
Country [148]
0
0
Spain
Query!
State/province [148]
0
0
Sevilla
Query!
Country [149]
0
0
Spain
Query!
State/province [149]
0
0
Valencia
Query!
Country [150]
0
0
Sweden
Query!
State/province [150]
0
0
Lund
Query!
Country [151]
0
0
Sweden
Query!
State/province [151]
0
0
Stockholm
Query!
Country [152]
0
0
Sweden
Query!
State/province [152]
0
0
Uppsala
Query!
Country [153]
0
0
Sweden
Query!
State/province [153]
0
0
Örebro
Query!
Country [154]
0
0
Taiwan
Query!
State/province [154]
0
0
Kaohsiung
Query!
Country [155]
0
0
Taiwan
Query!
State/province [155]
0
0
Taoyuan
Query!
Country [156]
0
0
United Kingdom
Query!
State/province [156]
0
0
Greater London
Query!
Country [157]
0
0
United Kingdom
Query!
State/province [157]
0
0
South Yorkshire
Query!
Country [158]
0
0
United Kingdom
Query!
State/province [158]
0
0
Staffordshire
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Biogen
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of this study is to evaluate the long-term safety and tolerability of
litifilimab in participants with active systemic lupus erythematosus (SLE).
The secondary objectives of this study are to evaluate the long-term effect of litifilimab on
disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in
participants with SLE in maintaining low disease activity, to evaluate the effect of
litifilimab in participants with active SLE in preventing irreversible organ damage, to
assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab
treatment, to assess the impact of litifilimab on participant-reported Health-Related
Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term
effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of
litifilimab.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05352919
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Biogen
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05352919
Download to PDF