RecruitingPHASE2, PHASE3INTERVENTIONAL

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

This study, split into two main parts, is exploring a new treatment called litifilimab (given as an injection) for adults with active forms of lupus that primarily affect the skin (known as subacute or chronic cutaneous lupus erythematosus, or CLE). This includes people who might also have systemic lupus erythematosus (SLE) and whose current anti-malarial medications haven't worked well or caused too many side effects. The main goals are to understand how well litifilimab reduces skin symptoms like redness and rashes, and to assess its safety. Participants will receive either litifilimab or a placebo (a dummy injection) for 24 weeks, followed by 28 weeks where everyone receives litifilimab, with options for long-term follow-up. The study aims to provide clearer answers about this potential new treatment.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Biogen

Enrolment target

450

Start

13 Sep 2022

Estimated completion

14 Dec 2027

Subacute Cutaneous Lupus Erythematosus Chronic Cutaneous Lupus Erythematosus

What is this study about?

This study is looking into a new treatment called litifilimab for adults living with cutaneous lupus erythematosus (CLE). This is a type of lupus that mainly affects the skin, causing rashes and sores. The study includes people with different forms of CLE, such as subacute and chronic types, and some may also have systemic lupus erythematosus (SLE), which affects organs throughout the body. Importantly, this study focuses on individuals whose current treatments, like anti-malarial medications, haven't been effective enough or have caused side effects that make them difficult to continue.

The main purpose of this research is to see if litifilimab can help improve skin symptoms in people with CLE. The researchers will be carefully monitoring changes in skin redness, rashes, and overall disease activity using various scoring systems. They also want to understand if the medication is safe and how it affects a person's immune system. Additionally, the study will look at how CLE and the new treatment impact the participants' quality of life, which is a very important aspect of living with a long-term condition.

By answering questions about how many people see significant improvement in their skin symptoms and how safe the treatment is, this study aims to gather important information about litifilimab. This could potentially lead to a new treatment option for those with CLE who are struggling to manage their condition with existing therapies. The findings will help doctors and patients make more informed decisions about future treatment for this challenging condition.

Key takeaways

This study is testing an injection called litifilimab for lupus affecting the skin (CLE).
It's for adults whose current anti-malarial treatments for CLE aren't working well.
Participants will initially receive litifilimab or a placebo, then everyone receives litifilimab.
The main goals are to check if litifilimab reduces skin symptoms and to understand its safety.
Participation involves regular visits and injections over approximately 80 weeks.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, adults aged 18 and over must have a confirmed diagnosis of cutaneous lupus erythematosus (CLE) that is currently active and affecting their skin. Your skin symptoms should be significant, and you should have already tried anti-malarial treatments without enough success.

There are also certain conditions that would prevent you from taking part. For example, if you have other active skin conditions that could make it hard for doctors to assess your CLE, or if you have certain severe types of lupus affecting your kidneys or brain. If you've recently started or changed doses of other specific lupus or immune-suppressing medications, you might also not be able to join.

The study aims to include people whose CLE is specifically active and hasn't responded to standard treatments, while making sure it's safe for participants to receive the study drug. The research team will carefully review all your medical information to see if you meet all the criteria.

Quick self-check

Are you 18 years old or older?
Do you have an active form of lupus affecting your skin (CLE)?
Have other treatments, like anti-malarials, not worked well for your CLE?
Do you have significant skin symptoms from your lupus (as judged by a doctor)?
Do you have any other severe lupus conditions affecting your kidneys or brain?
Have you recently changed doses or started other specific lupus medications in the last 12 weeks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, it will be divided into two main periods. Initially, for 24 weeks, you will be randomly assigned to receive either the study drug, litifilimab, or a placebo (an injection that looks the same but contains no medicine). Neither you nor the study team will know which you are receiving during this time. Both are given as injections under the skin once every four weeks.

After these 24 weeks, all participants will receive litifilimab injections for an additional 28 weeks. During the study, you will have regular visits where the team will monitor your skin symptoms, overall health, and any side effects. They'll use questionnaires to understand how your condition and the treatment affect your daily life.

The total active participation in the study will be up to 80 weeks (about a year and a half). Once your treatment period is complete, you might have the option to join a separate long-term study for continued treatment, or you'll enter a safety follow-up period for up to 24 weeks.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical monitoring. However, there are also potential risks; litifilimab is an experimental drug, and its side effects are not yet fully known. There's a chance you might receive a placebo and not the active drug during the initial phase, meaning your symptoms might not improve or could even worsen. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (314)

Pinnacle Research Group, LLC
Anniston, United States· Recruiting
UAB Center for Women's Reproductive Health
Birmingham, United States· Recruiting
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, United States· Recruiting
The Regents of the University of California
La Jolla, United States· Recruiting
Dermatology Research Associates
Los Angeles, United States· Recruiting
Clinical Science Institute
Santa Monica, United States· Completed
Inland Rheumatology Clinical Trials, Inc.
Upland, United States· Recruiting
Denver Arthritis Clinic
Denver, United States· Completed
Omega Research Debary, LLC
DeBary, United States· Recruiting
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, United States· Completed
University of Florida
Gainesville, United States· Completed
University of Miami Miller School of Medicine
Miami, United States· Recruiting

+302 more sites — see the official record for the full list.

Common questions

What is cutaneous lupus erythematosus (CLE)?

CLE is a type of lupus that primarily affects the skin, causing rashes, sores, or lesions, mostly on sun-exposed areas.

What is a 'placebo'?

A placebo is an inactive substance, or a 'dummy' treatment, that looks exactly like the study drug but contains no actual medicine. It helps researchers understand the true effect of the active medication.

What does 'double-blinded' mean?

Double-blinded means that neither the patient receiving the treatment nor the doctors and nurses giving it know whether the patient is getting the actual study drug or a placebo. This helps ensure the study results are unbiased.

How is the study drug administered?

The study drug, litifilimab, or the placebo, will be given as an injection under the skin once every four weeks.

What happens after the study ends?

After completing the main study, you might have the option to join a separate long-term study, or you will enter a safety follow-up period for several months.

How to find out more

US Biogen Clinical Trial Center

clinicaltrials@biogen.com 866-633-4636 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.