Litifilimab for Lupus
(EMERALD Trial)

Recruiting in Palo Alto (17 mi)

+549 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Biogen

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

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.

Inclusion Criteria

I completed a 52-week trial for litifilimab or placebo and attended all required visits.

Exclusion Criteria

I am not using experimental or off-label drugs for lupus.

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)

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Treatment Details

Interventions

BIIB059 (litifilimab) (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.