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Monoclonal Antibodies
Litifilimab for Lupus (EMERALD Trial)
Phase 3
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 180
Awards & highlights
Summary
This trial is testing litifilimab, a medication for people with active systemic lupus erythematosus (SLE). It aims to see if the drug can safely reduce the immune system's attack on the body, helping to manage symptoms and prevent organ damage. Litifilimab has shown promise in reducing the number of swollen and tender joints in SLE patients.
Who is the study for?
This trial is for adults with active systemic lupus erythematosus (SLE) who finished one of the parent Phase 3 studies. They must have completed treatment up to Week 48 and attended their last study visit at Week 52.
What is being tested?
The trial is testing the long-term safety and effectiveness of a drug called Litifilimab in people with SLE. It will compare ongoing Litifilimab use against a placebo, looking at disease activity, organ damage prevention, corticosteroid use, quality of life, symptoms impact, lab parameters, and immune response.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with drugs like Litifilimab may include injection site reactions, infections due to weakened immune system responses, allergic reactions or rashes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I completed a 52-week trial for litifilimab or placebo and attended all required visits.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lupus has worsened, needing stronger medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 180
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Serious Adverse Events (SAEs)
Therapeutic procedure
Secondary study objectives
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
Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate
Change From Baseline in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
+14 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Litifilimab Low DoseExperimental Treatment2 Interventions
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.
Group II: Litifilimab High DoseExperimental Treatment2 Interventions
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Lupus include immunosuppressive drugs, corticosteroids, and biologics. Immunosuppressive drugs like mycophenolate mofetil and cyclophosphamide reduce the activity of the immune system to prevent it from attacking the body's own tissues.
Corticosteroids like prednisone reduce inflammation and suppress the immune response. Biologics, such as belimumab and rituximab, target specific components of the immune system; belimumab inhibits B-lymphocyte stimulator (BLyS) to reduce B cell activity, while rituximab targets CD20 on B cells to deplete them.
Litifilimab, a monoclonal antibody targeting BDCA2, aims to reduce type I interferons and inflammatory cytokines, which are key drivers of inflammation in Lupus. These mechanisms are crucial for Lupus patients as they help control the overactive immune response, reduce inflammation, and prevent organ damage.
Unmet Needs in the Pathogenesis and Treatment of Systemic Lupus Erythematosus.New Trials in Lupus and where Are we Going.Advances in drug therapy for systemic lupus erythematosus.
Unmet Needs in the Pathogenesis and Treatment of Systemic Lupus Erythematosus.New Trials in Lupus and where Are we Going.Advances in drug therapy for systemic lupus erythematosus.
Find a Location
Who is running the clinical trial?
BiogenLead Sponsor
643 Previous Clinical Trials
466,355 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,849 Previous Clinical Trials
8,080,016 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I completed a 52-week study (230LE303 or 230LE304) and attended all required visits.I completed a 52-week trial for litifilimab or placebo and attended all required visits.I am not using experimental or off-label drugs for lupus.My lupus has worsened, needing stronger medication.I'm sorry, I cannot provide a summary for "Key" as it is not a complete screening criterion. Can you please provide me with more information or context?
Research Study Groups:
This trial has the following groups:- Group 1: Litifilimab Low Dose
- Group 2: Litifilimab High Dose
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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