Active — Not RecruitingPhase 2/3

A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

United States, Argentina, Belgium450 participantsStarted 2022-09-13

Plain-language summary

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms and signs of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). The main questions researchers want to answer are: * How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment? * How many participants have their skin disease activity go down by at least 70% as measured by CLASI? Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires. The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows: * After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine. * Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. * The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. * This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin. * During the 2nd treatment period, all participants will receive litifilimab for 28 weeks. * After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks. * The total study duration for participants will be up to 80 weeks.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
. Must have active cutaneous manifestations that meet study criteria.
. Must have a CLASI-A score ≥10.
. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.

Exclusion criteria

. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
. Diagnosis of mixed connective tissue disease \[(within 1 year of signing the informed consent form (ICF)\] or any history of overlap syndromes of SLE including concomitant presence with rheumatoid arthritis, dermatomyositis and/or polymyositis, systemic sclerosis, psoriatic arthritis, or any other autoimmune disease that may confound the evaluation of the disease activity or the effect of the investigational product. Exceptions for overlap syndrome of SLE include participants with overlap syndrome of SLE with myositis and secondary Sjögren's syndrome at screening is permitted provided the participant also meets the criteria for classification as SLE. A past history of mixed connective tissue disease that over time has developed into a diagnosis of SLE is permitted, provided diagnosis of SLE has been present for at least 1 year.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is in Phase 2/3 and is no longer recruiting — does that mean results might be available soon, and could those results change whether litifilimab becomes a real treatment option for my type of cutaneous lupus?
2The trial is specifically measuring whether the skin redness score drops to near zero, and whether overall disease activity improves by at least 70% — based on what you know about my current disease severity, do those sound like realistic goals for someone in my situation?
3Since this study covers both subacute and chronic cutaneous lupus erythematosus, does it matter which type I have when thinking about whether this drug might work for me, and which type do I actually have?
4Litifilimab is given as an injection — if I were ever eligible for a trial like this, how often would I need to come in for injections or monitoring visits, and is that something that would be manageable with my daily life?
5Before considering an experimental drug like litifilimab, should I first try or exhaust the standard treatments for cutaneous lupus, or is there a reason it might make sense to look at trials like this one earlier in my treatment journey?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Parts A: Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1

Timeframe: Week 16

Part B: Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline

Timeframe: Baseline to Week 24

Trial details

NCT IDNCT05531565

SponsorBiogen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-20

View on ClinicalTrials.gov More Subacute Cutaneous Lupus Erythematosus trials