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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 180
Awards & highlights

EMERALD Trial Summary

This trial is evaluating the safety and long-term effectiveness of a drug for people with Lupus.

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.Check my eligibility
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.See study design
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.

EMERALD Trial 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.

EMERALD Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Serious Adverse Events (SAEs)
Therapeutic procedure
Secondary outcome measures
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)
+19 more

EMERALD 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.

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
466,570 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,769 Previous Clinical Trials
8,061,336 Total Patients Enrolled

Media Library

BIIB059 (litifilimab) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05352919 — Phase 3
Lupus Research Study Groups: Litifilimab Low Dose, Litifilimab High Dose
Lupus Clinical Trial 2023: BIIB059 (litifilimab) Highlights & Side Effects. Trial Name: NCT05352919 — Phase 3
BIIB059 (litifilimab) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05352919 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are being enrolled in this particular experiment?

"The correct answer is that this study, which was first posted on 6/10/2022 and updated on 7/20/2022 according to clinicaltrials.gov, is currently seeking volunteers. In total, 864 individuals are needed for the 62 different sites where the trial will take place."

Answered by AI

Are participants still being recruited for this experiment?

"The trial, which was originally posted on June 10th, 2022 and has since been updated, is still recruiting patients according to the information available on clinicaltrials.gov."

Answered by AI

What are the side effects of BIIB059?

"There is a fair amount of evidence, from both Phase 3 trials and other sources, that suggests BIIB059 is safe. Therefore, it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Michigan
How old are they?
18 - 65
What site did they apply to?
Research Site
University of Massachusetts
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I wanna put effort into helping research options in all regards to Lupus. If this is something one day we can prevent or cure for other generations so they don't have to go thru the same things I have then I wanna do all that I can.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. Saint Louis Rheumatology: < 24 hours
Typically responds via
Email
~576 spots leftby Mar 2029