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Enrolling by invitationPhase 3

Long-term safety of litifilimab in adults with systemic lupus erythematosus

Tests litifilimab injections for long-term safety in adults with lupus.

Key facts

Who runs it
Biogen
Where
Armenia, Barranquilla, Bogotá, Bucaramanga, Cali, Chía, Floridablanca, Manizales, Medellín, and Zipaquirá, ColombiaSee the 11 sitesAlso in 30 other countries, 211 sites
Registry title
A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE)
Status
Enrolling by invitation
Phase
Phase 3
People taking part
864 people, planned
Started
10 Jun 2022
Expected to end
3 May 2032
Type of study
Interventional, 2 groups
Treatments tested
  • Litifilimab
  • Litifilimab-matching placebo
Record updated
5 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with active lupus (SLE) who finished one of the two earlier litifilimab studies, 230LE303 or 230LE304, through Week 52.

Age
18 years or older
Sex
Women and men can join.
Disease stage
Active systemic lupus erythematosus (SLE) at the time of the earlier studies.
Earlier treatment
Must have completed the 52-week earlier study (230LE303 or 230LE304) on litifilimab or placebo and attended the Week 52 visit. Must not have used other investigational or off-label lupus drugs during that study.

Main reasons for not taking part

  • Stopped study treatment before Week 52 in the earlier study
  • Left the earlier study before finishing the 52-week treatment period
  • Lupus of an organ got moderately to severely worse and needed a change in antimalarial or immune-suppressing treatment
  • Used other investigational or off-label drugs for lupus, skin lupus or lupus nephritis during the earlier study

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies; NOTE: Other inclusion/exclusion criteria may apply
  • 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)

Where in Colombia

Also in 30 other countries, 211 sites

  • Fundacion Cardiomet CEQUIN S.A.SArmenia, ColombiaNo longer taking part
  • Centro de Investigacion Medico Asistencial S.A.SBarranquilla, ColombiaNo longer taking part
  • Clínica de la Costa S.A.SBarranquilla, ColombiaNo longer taking part
  • Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.Bogotá, ColombiaNo longer taking part
  • Servimed S.A.SBucaramanga, ColombiaNo longer taking part
  • IPS Centro Medico Julian Coronel S.A.Cali, ColombiaNo longer taking part
  • Preventive Care LtdaChía, ColombiaNo longer taking part
  • Fundacion Oftalmologica de Santander - FOSCALFloridablanca, ColombiaNo longer taking part
  • IPS Medicos Internistas de Caldas S.A.SManizales, ColombiaNo longer taking part
  • Centro de Investigacion Clinica CICMedellín, ColombiaNo longer taking part
  • Healthy Medical CenterZipaquirá, ColombiaNo longer taking part

About the trial

What the trial wants to find out

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on adults who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will include participants who completed the treatment periods of either one of those parent studies.

Read full original descriptionShow less

The main goal of the study is to learn more about the long-term safety of litifilimab in adults. The main question researchers want to answer is:

- How many participants have adverse events and serious adverse events during the study? Adverse events are health problems that may or may not be caused by the study drug.

Researchers will also learn about:

* The effect of litifilimab on controlling symptoms of SLE and lowering its activity. * How participants' immune systems respond to litifilimab. * The effect of litifilimab on the quality of life of participants.

The study will be done as follows:

* This study begins when the participant has finished 1 of the parent studies (either 230LE303 or 230LE304). * Participants who were getting either a high or low dose of litifilimab in either parent study will continue getting the same doses. * Participants who were getting the placebo in the parent studies will be randomized to get either a high or low dose of litifilimab. * Neither the researchers nor the participants will know which doses of litifilimab the participants are getting. * All participants will get litifilimab as injections under the skin once every 4 weeks. The treatment period will last up to 260 weeks. Participants may continue to take their standard of care medications. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 73 study visits. At these visits, the study doctor will do tests to check the participants' overall health, including the status of their SLE symptoms. They will also measure the participants' height, weight, and vital signs and collect blood and urine samples. Participants will also complete questionnaires or answer questions about how they are feeling and about their daily lives. * Each participant will be in the study for up to 284 weeks.

Optional Substudy:

* Some participants may be invited to join an optional "substudy" after being in the main study for at least 4 months. * This substudy will test a new injector device for delivering litifilimab. The injector device is an automatic device that delivers the full dose in 1 injection without needing to push a plunger. * Researchers will learn more about the safety of the injector device and how the body reacts to it. This will be compared to the current prefilled syringe method. * The substudy will last up to 3 months and will include about 120 participants.

The 2 groups in the trial

  • Litifilimab Low DoseTreatment being tested

    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 to 260 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 to 260 weeks with an additional dose at Week 2.

    Treatment: Litifilimab and Litifilimab-matching placebo

  • Litifilimab High DoseTreatment being tested

    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 to 260 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 to 260 weeks with an additional dose at Week 2.

    Treatment: Litifilimab and Litifilimab-matching placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus
Plain-language title
Long-term safety of litifilimab in adults with systemic lupus erythematosusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
5 October 2026