What side effects are associated with this type of intervention?

Common treatments for Lupus, particularly monoclonal antibodies like Litifilimab, include drugs such as rituximab, belimumab, and epratuzumab. Known side effects of these treatments can include infusion reactions, increased risk of infections, and potential allergic reactions. Rituximab has been associated with serum-sickness-like reactions and, in rare cases, progressive multifocal encephalopathy. Belimumab may cause nausea, diarrhea, and fever. Overall, while these treatments can be effective, they require careful monitoring for adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for lupus, including monoclonal antibodies that target specific pathways involved in the disease. Belimumab (Benlysta) was the first biologic approved for lupus, targeting the B-lymphocyte stimulator (BLyS) to reduce B-cell activity. More recently, anifrolumab (Saphnelo) was approved, which targets the type I interferon receptor, thereby reducing the inflammatory response. These treatments are similar to litifilimab, which targets BDCA2 to reduce type I interferons and inflammatory cytokines, aiming to control disease activity and prevent organ damage in lupus patients.

What other types of research exist?

Promising alternatives to Litifilimab for Lupus patients include Anifrolumab (a monoclonal antibody targeting the type I interferon receptor), Belimumab (a monoclonal antibody targeting B-lymphocyte stimulator), and Voclosporin (a calcineurin inhibitor). These treatments have shown efficacy in reducing disease activity and inflammation in SLE.

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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

Pivotal Trial

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 180 for reporting.

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 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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.

0 / 2Eligibility criteria met

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.