A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections an… (NCT06044337) | Clinical Trial Compass
By InvitationPhase 3
A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
United States, Argentina, Brazil306 participantsStarted 2023-10-03
Plain-language summary
In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) 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 study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301.
The main objective of the study is to learn more about the long-term safety of litifilimab.
The main question researchers want to answer is:
* How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are health problems that may or may not be caused by the study drug.
Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms 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).
Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab.
The study will be done as follows:
* The last visit of parent study 230LE301 will be the first visit of study 230LE305.
* All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug.
* Globally, the treatment period will last up to 208 weeks, or 4 years. Participants will have up to 53 study visits during this time.
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.
Key Inclusion Criteria:
* Participants who completed the parent study (230LE301 \[NCT05531565\], Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52).
* Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
Key Exclusion Criteria:
* Early Part A or Part B parent study (230LE301 \[NCT05531565\]) treatment terminators (participants who discontinued study treatment before Week 48).
* Early Part A or Part B parent study terminators \[participants who withdrew from parent study participation before Week 52 and did not complete the parent study extended treatment period (ETP)\].
* Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the long-term extension (LTE) study unsuitable in the opinion of the Investigator.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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.
1Since this is a long-term extension study that's enrolling by invitation only, does my history with litifilimab or a prior related trial make me a candidate to even be considered for this study?
2The main thing being measured in this trial is how many people experience serious side effects over the long term — what does that tell us about how well the safety of litifilimab is actually understood at this point, and should that affect my decision?
3Because this is a Phase 3 extension study focused on long-term safety in cutaneous lupus, how does the duration and commitment involved compare to what I'd face with standard treatments for my subacute or chronic cutaneous lupus?
4Are there already approved or well-established treatments for my type of cutaneous lupus that I should try first before considering participation in a long-term extension study like this one?
5If I were invited to join this trial, what would the injection schedule look like in practice, and how might that fit into my day-to-day life over the long term?
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
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)