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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 June 2025
• Main ID: NCT05352919
• Date of registration: 25/04/2022
• Prospective Registration: Yes
• Primary sponsor: Biogen
• 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 EMERALD
• 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
• Date of first enrolment: June 10, 2022
• Target sample size: 864
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/ct2/show/NCT05352919
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Serbia, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- 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 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.


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus (SLE)

Intervention(s)

Drug: Litifilimab

Drug: Litifilimab-matching placebo

Primary Outcome(s)

Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to Week 180]

Number of Participants with Serious Adverse Events (SAEs) [Time Frame: Up to Week 180]

Secondary Outcome(s)

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 [Time Frame: Up to Week 156]

Change from Baseline in Patient Global Assessment (PtGA) Score [Time Frame: Up to Week 156]

Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score [Time Frame: Up to Week 156]

Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS [Time Frame: Up to Week 180]

Percentage of Participants With OCS =5 mg [Time Frame: Up to Week 156]

Change From Baseline in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) [Time Frame: Up to Week 156]

Number of Participants with Antibodies to Litifilimab [Time Frame: Up to Week 180]

Percentage of Participants With OCS =7.5 mg [Time Frame: Up to Week 156]

Change From Baseline in Lupus-Specific Health-Related Quality-Of-Life (LupusQoL) Score [Time Frame: Up to Week 156]

Change From Baseline in Work Productivity and Activity Impairment (WPAI):Lupus Score [Time Frame: Up to Week 156]

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 [Time Frame: Up to Week 180]

Percentage of Participants With Sustained LLDAS [Time Frame: Up to Week 180]

Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate [Time Frame: Up to Week 156]

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score [Time Frame: Up to Week 156]

Cumulative Exposure to OCS Over Time [Time Frame: Up to Week 156]

Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response [Time Frame: Up to Week 180]

Change From Baseline in Short Form Health Survey-36 (SF-36) (Acute Version) Score [Time Frame: Up to Week 156]

Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECG) Results [Time Frame: Up to Week 156]

Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters [Time Frame: Up to Week 180]

Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response [Time Frame: Up to Week 180]

Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline who Achieved a Joint-50 Response [Time Frame: Up to Week 180]

Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS) [Time Frame: Up to Week 180]

Secondary ID(s)

2021-006378-22

230LE306

2023-505635-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors