Enrolling by invitation

EMERALDLitifilimab Safety and Efficacy in Systemic Lupus Erythematosus

Study Aim

This study aims to evaluate the safety and effectiveness of Litifilimab in people with systemic lupus erythematosus, focusing on any serious or treatment-related adverse events.

What is being tested

Litifilimab

+ Litifilimab-matching placebo

Drug

Who is being recruted

Autoimmune Diseases+2

+ Connective Tissue Diseases

+ Immune System Diseases

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: June 2022

See protocol details

Summary

Principal SponsorBiogen

Last updated: March 21, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 10, 2022

Actual date on which the first participant was enrolled.

This study focuses on adults with active Systemic Lupus Erythematosus (SLE), an autoimmune disease. It's an extension of previous studies, aiming to evaluate the long-term safety and effectiveness of a drug called Litifilimab (BIIB059). The goal is to understand how well this drug manages disease activity, prevents organ damage, and improves quality of life for SLE patients over an extended period. The study also includes a sub-study to assess the safety and tolerability of the injector device used for administering Litifilimab. Participants who have completed the previous studies and did not discontinue Litifilimab or placebo are eligible. They will be followed for up to 180 weeks. The study measures various outcomes, including the number of participants experiencing serious adverse events (SAEs) and treatment emergent adverse events (TEAEs). SAEs are any medical issues that could result in death or hospitalization, while TEAEs are any unfavorable symptoms or diseases that start or worsen after the first dose of the study treatment. The sub-study evaluates the safety and comfort of using the injector device for Litifilimab administration.

Official TitleA 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

NCT05352919

Principal SponsorBiogen

Last updated: March 21, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

864 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesLupus Erythematosus, SystemicSkin and Connective Tissue Diseases

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Experimental

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 182 locations

Suspended

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, United StatesOpen Arizona Arthritis & Rheumatology Associates, P.C. in Google Maps

Suspended

Wallace Rheumatic Study Center

Beverly Hills, United States

Suspended

Care Access Research - Huntington Beach

Huntington Beach, United States

Suspended

Kindai University Hospital

Osakasayama-shi, Japan

Enrolling by invitation182 Study Centers