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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

Titles & IDs
Public title
An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
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:
Systemic Lupus Erythematosus (SLE) 0 0
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 With at Least 4 Joints (Both Swollen and Tender) at Baseline who Achieved a Joint-50 Response
Timepoint [2] 0 0
Up to Week 180
Secondary outcome [3] 0 0
Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) Score =10 at Baseline who Achieved a CLASI-50, CLASI-70, and CLASI-90 Response
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
29/03/2030
Actual
Sample size
Target
864
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Tucuman
Country [16] 0 0
Argentina
State/province [16] 0 0
Ciudad Autonoma Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Mendoza
Country [18] 0 0
Argentina
State/province [18] 0 0
San Juan
Country [19] 0 0
Belgium
State/province [19] 0 0
Liège
Country [20] 0 0
Brazil
State/province [20] 0 0
Bahia
Country [21] 0 0
Brazil
State/province [21] 0 0
Ceara
Country [22] 0 0
Brazil
State/province [22] 0 0
Distrito Federal
Country [23] 0 0
Brazil
State/province [23] 0 0
Mato Grosso
Country [24] 0 0
Brazil
State/province [24] 0 0
Minas Gerais
Country [25] 0 0
Brazil
State/province [25] 0 0
Paraná
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio Grande Do Sul
Country [27] 0 0
Brazil
State/province [27] 0 0
Sao Paulo
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Plovdiv
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Ruse
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Sofia
Country [31] 0 0
Chile
State/province [31] 0 0
Santiago
Country [32] 0 0
China
State/province [32] 0 0
Beijing
Country [33] 0 0
China
State/province [33] 0 0
Guangdong
Country [34] 0 0
China
State/province [34] 0 0
Hunan
Country [35] 0 0
China
State/province [35] 0 0
Jiangxi
Country [36] 0 0
China
State/province [36] 0 0
Zhejiang
Country [37] 0 0
China
State/province [37] 0 0
Changchun
Country [38] 0 0
Colombia
State/province [38] 0 0
Valle Del Cauca
Country [39] 0 0
Colombia
State/province [39] 0 0
Barranquilla
Country [40] 0 0
Colombia
State/province [40] 0 0
Bogotá
Country [41] 0 0
Colombia
State/province [41] 0 0
Bucaramanga
Country [42] 0 0
Colombia
State/province [42] 0 0
Chia
Country [43] 0 0
Colombia
State/province [43] 0 0
Zipaquirá
Country [44] 0 0
Czechia
State/province [44] 0 0
Brno
Country [45] 0 0
Czechia
State/province [45] 0 0
Olomouc
Country [46] 0 0
France
State/province [46] 0 0
Drôme
Country [47] 0 0
Greece
State/province [47] 0 0
Attica
Country [48] 0 0
Hungary
State/province [48] 0 0
Fejer
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapest
Country [50] 0 0
Hungary
State/province [50] 0 0
Gyula
Country [51] 0 0
Hungary
State/province [51] 0 0
Veszprem
Country [52] 0 0
Israel
State/province [52] 0 0
Haifa
Country [53] 0 0
Israel
State/province [53] 0 0
Kfar- Saba
Country [54] 0 0
Israel
State/province [54] 0 0
Tel Aviv
Country [55] 0 0
Japan
State/province [55] 0 0
Aichi-Ken
Country [56] 0 0
Japan
State/province [56] 0 0
Chiba-Ken
Country [57] 0 0
Japan
State/province [57] 0 0
Fukuoka-Ken
Country [58] 0 0
Japan
State/province [58] 0 0
Hiroshima-Ken
Country [59] 0 0
Japan
State/province [59] 0 0
Hokkaido
Country [60] 0 0
Japan
State/province [60] 0 0
Hyogo-Ken
Country [61] 0 0
Japan
State/province [61] 0 0
Kagawa-Ken
Country [62] 0 0
Japan
State/province [62] 0 0
Kanagawa-Ken
Country [63] 0 0
Japan
State/province [63] 0 0
Kumamoto-Ken
Country [64] 0 0
Japan
State/province [64] 0 0
Osaka-Fu
Country [65] 0 0
Japan
State/province [65] 0 0
Tokyo-To
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Gyeonggi-do
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Seoul
Country [68] 0 0
Mexico
State/province [68] 0 0
Distrito Federal
Country [69] 0 0
Mexico
State/province [69] 0 0
Jalisco
Country [70] 0 0
Mexico
State/province [70] 0 0
Morelos
Country [71] 0 0
Mexico
State/province [71] 0 0
Yucatán
Country [72] 0 0
Mexico
State/province [72] 0 0
Chihuahua
Country [73] 0 0
Mexico
State/province [73] 0 0
Durango
Country [74] 0 0
Philippines
State/province [74] 0 0
Batangas
Country [75] 0 0
Philippines
State/province [75] 0 0
Davao
Country [76] 0 0
Philippines
State/province [76] 0 0
Metro Manila
Country [77] 0 0
Philippines
State/province [77] 0 0
Manila
Country [78] 0 0
Poland
State/province [78] 0 0
Bialystok
Country [79] 0 0
Poland
State/province [79] 0 0
Bydgoszcz
Country [80] 0 0
Poland
State/province [80] 0 0
Bytom
Country [81] 0 0
Poland
State/province [81] 0 0
Krakow
Country [82] 0 0
Poland
State/province [82] 0 0
Malbork
Country [83] 0 0
Poland
State/province [83] 0 0
Warszawa
Country [84] 0 0
Puerto Rico
State/province [84] 0 0
Caguas
Country [85] 0 0
Romania
State/province [85] 0 0
Brasov
Country [86] 0 0
Romania
State/province [86] 0 0
Bucuresti
Country [87] 0 0
Romania
State/province [87] 0 0
Cluj-Napoca
Country [88] 0 0
Romania
State/province [88] 0 0
Iasi
Country [89] 0 0
Serbia
State/province [89] 0 0
Belgrade
Country [90] 0 0
Spain
State/province [90] 0 0
Castellón
Country [91] 0 0
Spain
State/province [91] 0 0
Barcelona
Country [92] 0 0
Spain
State/province [92] 0 0
Sevilla
Country [93] 0 0
Taiwan
State/province [93] 0 0
Kaohsiung
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Greater London
Country [95] 0 0
United Kingdom
State/province [95] 0 0
South Yorkshire

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05352919