Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05352919




Registration number
NCT05352919
Ethics application status
Date submitted
25/04/2022
Date registered
29/04/2022
Date last updated
5/11/2024

Titles & IDs
Public title
A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus
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
Secondary ID [1] 0 0
2021-006378-22
Secondary ID [2] 0 0
230LE306
Universal Trial Number (UTN)
Trial acronym
EMERALD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to Week 180
Primary outcome [2] 0 0
Number of Participants with Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to Week 180
Secondary outcome [1] 0 0
Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response
Timepoint [1] 0 0
Up to Week 180
Secondary outcome [2] 0 0
Percentage of Participants who Achieved a Joint-50 Response
Timepoint [2] 0 0
Up to Week 180
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
Timepoint [3] 0 0
Up to Week 180
Secondary outcome [4] 0 0
Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response
Timepoint [4] 0 0
Up to Week 180
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
Timepoint [5] 0 0
Up to Week 156
Secondary outcome [6] 0 0
Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
Timepoint [6] 0 0
Up to Week 180
Secondary outcome [7] 0 0
Percentage of Participants With Sustained LLDAS
Timepoint [7] 0 0
Up to Week 180
Secondary outcome [8] 0 0
Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS
Timepoint [8] 0 0
Up to Week 180
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
Timepoint [9] 0 0
Up to Week 156
Secondary outcome [10] 0 0
Cumulative Exposure to OCS Over Time
Timepoint [10] 0 0
Up to Week 156
Secondary outcome [11] 0 0
Percentage of Participants With OCS =7.5 mg
Timepoint [11] 0 0
Up to Week 156
Secondary outcome [12] 0 0
Percentage of Participants With OCS =5 mg
Timepoint [12] 0 0
Up to Week 156
Secondary outcome [13] 0 0
Change From Baseline in Lupus-Specific Health-Related Quality-Of-Life (LupusQoL) Score
Timepoint [13] 0 0
Up to Week 156
Secondary outcome [14] 0 0
Change From Baseline in Short Form Health Survey-36 (SF-36) (Acute Version) Score
Timepoint [14] 0 0
Up to Week 156
Secondary outcome [15] 0 0
Change From Baseline in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
Timepoint [15] 0 0
Up to Week 156
Secondary outcome [16] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score
Timepoint [16] 0 0
Up to Week 156
Secondary outcome [17] 0 0
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
Timepoint [17] 0 0
Up to Week 156
Secondary outcome [18] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI):Lupus Score
Timepoint [18] 0 0
Up to Week 156
Secondary outcome [19] 0 0
Change from Baseline in Patient Global Assessment (PtGA) Score
Timepoint [19] 0 0
Up to Week 156
Secondary outcome [20] 0 0
Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters
Timepoint [20] 0 0
Up to Week 180
Secondary outcome [21] 0 0
Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECG) Results
Timepoint [21] 0 0
Up to Week 156
Secondary outcome [22] 0 0
Number of Participants with Antibodies to Litifilimab
Timepoint [22] 0 0
Up to Week 180

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/03/2029
Actual
Sample size
Target
864
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Box Hill Hospital - Caulfield
Recruitment hospital [3] 0 0
Footscray Hospital - Footscray
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3162 - Caulfield
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Tucuman
Country [24] 0 0
Argentina
State/province [24] 0 0
Ciudad Autonoma Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Mendoza
Country [26] 0 0
Argentina
State/province [26] 0 0
San Juan
Country [27] 0 0
Belgium
State/province [27] 0 0
Leuven
Country [28] 0 0
Belgium
State/province [28] 0 0
Liege
Country [29] 0 0
Brazil
State/province [29] 0 0
Bahia
Country [30] 0 0
Brazil
State/province [30] 0 0
Ceará
Country [31] 0 0
Brazil
State/province [31] 0 0
Distrito Federal
Country [32] 0 0
Brazil
State/province [32] 0 0
Espírito Santo
Country [33] 0 0
Brazil
State/province [33] 0 0
Mato Grosso
Country [34] 0 0
Brazil
State/province [34] 0 0
Minas Gerais
Country [35] 0 0
Brazil
State/province [35] 0 0
Paraná
Country [36] 0 0
Brazil
State/province [36] 0 0
Rio Grande Do Sul
Country [37] 0 0
Brazil
State/province [37] 0 0
Sao Paulo
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Plovdiv
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Ruse
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Sofia
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Chile
State/province [42] 0 0
Osorno
Country [43] 0 0
Chile
State/province [43] 0 0
Santiago
Country [44] 0 0
China
State/province [44] 0 0
Beijing
Country [45] 0 0
China
State/province [45] 0 0
Guangdong
Country [46] 0 0
China
State/province [46] 0 0
Hainan
Country [47] 0 0
China
State/province [47] 0 0
Hubei
Country [48] 0 0
China
State/province [48] 0 0
Hunan
Country [49] 0 0
China
State/province [49] 0 0
Jiangxi
Country [50] 0 0
China
State/province [50] 0 0
Jilin
Country [51] 0 0
China
State/province [51] 0 0
Shandong
Country [52] 0 0
China
State/province [52] 0 0
Shanghai
Country [53] 0 0
China
State/province [53] 0 0
Sichuan
Country [54] 0 0
China
State/province [54] 0 0
Tianjin
Country [55] 0 0
China
State/province [55] 0 0
Xinjiang
Country [56] 0 0
China
State/province [56] 0 0
Zhejiang
Country [57] 0 0
Colombia
State/province [57] 0 0
Barranquilla
Country [58] 0 0
Colombia
State/province [58] 0 0
Bogotá
Country [59] 0 0
Colombia
State/province [59] 0 0
Bucaramanga
Country [60] 0 0
Colombia
State/province [60] 0 0
Chia
Country [61] 0 0
Colombia
State/province [61] 0 0
Zipaquirá
Country [62] 0 0
Czechia
State/province [62] 0 0
Brno
Country [63] 0 0
Czechia
State/province [63] 0 0
Olomouc
Country [64] 0 0
France
State/province [64] 0 0
Gironde
Country [65] 0 0
France
State/province [65] 0 0
Herault
Country [66] 0 0
France
State/province [66] 0 0
Puy De Dome
Country [67] 0 0
France
State/province [67] 0 0
Paris
Country [68] 0 0
Germany
State/province [68] 0 0
Niedersachsen
Country [69] 0 0
Germany
State/province [69] 0 0
Nordrhein Westfalen
Country [70] 0 0
Germany
State/province [70] 0 0
Rheinland Pfalz
Country [71] 0 0
Greece
State/province [71] 0 0
Athens
Country [72] 0 0
Hungary
State/province [72] 0 0
Budapest
Country [73] 0 0
Hungary
State/province [73] 0 0
Gyula
Country [74] 0 0
Hungary
State/province [74] 0 0
Szekesfehervar
Country [75] 0 0
Hungary
State/province [75] 0 0
Veszprem
Country [76] 0 0
Israel
State/province [76] 0 0
Haifa
Country [77] 0 0
Israel
State/province [77] 0 0
Kfar- Sava
Country [78] 0 0
Israel
State/province [78] 0 0
Petach-Tikva
Country [79] 0 0
Israel
State/province [79] 0 0
Ramat Gan
Country [80] 0 0
Israel
State/province [80] 0 0
Tel Aviv
Country [81] 0 0
Italy
State/province [81] 0 0
Milano
Country [82] 0 0
Italy
State/province [82] 0 0
Salerno
Country [83] 0 0
Italy
State/province [83] 0 0
Brescia
Country [84] 0 0
Italy
State/province [84] 0 0
Padova
Country [85] 0 0
Italy
State/province [85] 0 0
Pisa
Country [86] 0 0
Italy
State/province [86] 0 0
Roma
Country [87] 0 0
Japan
State/province [87] 0 0
Aichi-Ken
Country [88] 0 0
Japan
State/province [88] 0 0
Chiba-Ken
Country [89] 0 0
Japan
State/province [89] 0 0
Fukuoka-Ken
Country [90] 0 0
Japan
State/province [90] 0 0
Hiroshima-Ken
Country [91] 0 0
Japan
State/province [91] 0 0
Hokkaido
Country [92] 0 0
Japan
State/province [92] 0 0
Hyogo-Ken
Country [93] 0 0
Japan
State/province [93] 0 0
Hyogo-ken
Country [94] 0 0
Japan
State/province [94] 0 0
Kagawa-Ken
Country [95] 0 0
Japan
State/province [95] 0 0
Kanagawa-Ken
Country [96] 0 0
Japan
State/province [96] 0 0
Kumamoto-Ken
Country [97] 0 0
Japan
State/province [97] 0 0
Miyagi-Ken
Country [98] 0 0
Japan
State/province [98] 0 0
Nagasaki-Ken
Country [99] 0 0
Japan
State/province [99] 0 0
Osaka-Fu
Country [100] 0 0
Japan
State/province [100] 0 0
Saitama-Ken
Country [101] 0 0
Japan
State/province [101] 0 0
Tokyo-To
Country [102] 0 0
Korea, Republic of
State/province [102] 0 0
Gyeonggi-do
Country [103] 0 0
Korea, Republic of
State/province [103] 0 0
Busan
Country [104] 0 0
Korea, Republic of
State/province [104] 0 0
Incheon
Country [105] 0 0
Korea, Republic of
State/province [105] 0 0
Seoul
Country [106] 0 0
Mexico
State/province [106] 0 0
Distrito Federal
Country [107] 0 0
Mexico
State/province [107] 0 0
Jalisco
Country [108] 0 0
Mexico
State/province [108] 0 0
Morelos
Country [109] 0 0
Mexico
State/province [109] 0 0
Nuevo León
Country [110] 0 0
Mexico
State/province [110] 0 0
Yucatán
Country [111] 0 0
Mexico
State/province [111] 0 0
Chihuahua
Country [112] 0 0
Mexico
State/province [112] 0 0
Durango
Country [113] 0 0
Netherlands
State/province [113] 0 0
Amsterdam
Country [114] 0 0
Netherlands
State/province [114] 0 0
Groningen
Country [115] 0 0
Netherlands
State/province [115] 0 0
Maastricht
Country [116] 0 0
Netherlands
State/province [116] 0 0
Utrecht
Country [117] 0 0
Peru
State/province [117] 0 0
Arequipa
Country [118] 0 0
Peru
State/province [118] 0 0
Lima
Country [119] 0 0
Philippines
State/province [119] 0 0
Davao City
Country [120] 0 0
Philippines
State/province [120] 0 0
Lipa City
Country [121] 0 0
Philippines
State/province [121] 0 0
Manila
Country [122] 0 0
Philippines
State/province [122] 0 0
Quezon City
Country [123] 0 0
Poland
State/province [123] 0 0
Bialystok
Country [124] 0 0
Poland
State/province [124] 0 0
Bydgoszcz
Country [125] 0 0
Poland
State/province [125] 0 0
Bytom
Country [126] 0 0
Poland
State/province [126] 0 0
Elblag
Country [127] 0 0
Poland
State/province [127] 0 0
Krakow
Country [128] 0 0
Poland
State/province [128] 0 0
Kraków
Country [129] 0 0
Poland
State/province [129] 0 0
Lublin
Country [130] 0 0
Poland
State/province [130] 0 0
Szczecin
Country [131] 0 0
Poland
State/province [131] 0 0
Warszawa
Country [132] 0 0
Poland
State/province [132] 0 0
Wroclaw
Country [133] 0 0
Puerto Rico
State/province [133] 0 0
Caguas
Country [134] 0 0
Romania
State/province [134] 0 0
Brasov
Country [135] 0 0
Romania
State/province [135] 0 0
Bucuresti
Country [136] 0 0
Romania
State/province [136] 0 0
Cluj-Napoca
Country [137] 0 0
Romania
State/province [137] 0 0
Iasi
Country [138] 0 0
Romania
State/province [138] 0 0
Targu Mures
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Kemerovo
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Moscow
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Orenburg
Country [142] 0 0
Russian Federation
State/province [142] 0 0
Saint Petersburg
Country [143] 0 0
Serbia
State/province [143] 0 0
Belgrade
Country [144] 0 0
Serbia
State/province [144] 0 0
Niska Banja
Country [145] 0 0
Spain
State/province [145] 0 0
Cantabria
Country [146] 0 0
Spain
State/province [146] 0 0
Barcelona
Country [147] 0 0
Spain
State/province [147] 0 0
Granada
Country [148] 0 0
Spain
State/province [148] 0 0
Sevilla
Country [149] 0 0
Spain
State/province [149] 0 0
Valencia
Country [150] 0 0
Sweden
State/province [150] 0 0
Lund
Country [151] 0 0
Sweden
State/province [151] 0 0
Stockholm
Country [152] 0 0
Sweden
State/province [152] 0 0
Uppsala
Country [153] 0 0
Sweden
State/province [153] 0 0
Örebro
Country [154] 0 0
Taiwan
State/province [154] 0 0
Kaohsiung
Country [155] 0 0
Taiwan
State/province [155] 0 0
Taoyuan
Country [156] 0 0
United Kingdom
State/province [156] 0 0
Greater London
Country [157] 0 0
United Kingdom
State/province [157] 0 0
South Yorkshire
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Staffordshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05352919
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05352919