Not yet recruitingRare disease

Lebrikizumab in Adults with Moderate to Severe Localized Scleroderma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying Localized Scleroderma, a condition that causes the skin to become hard and tight, and the medicine lebrikizumab. The medicine is given as an injection under the skin. The purpose of the study is to see how well lebrikizumab works and how safe it is compared with placebo in adults with moderate to severe localized scleroderma.

People in the study are assigned by chance to receive either lebrikizumab or placebo. The study is double-blind, which means that the people taking part and the study team do not know which treatment is being given. Treatment is given regularly over a period of about 24 weeks, and the skin condition is checked during the study. Side effects and general safety are also monitored.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study treatment period
After joining the study, you receive either lebrikizumab or a placebo that looks the same but does not contain the active medicine. The study is randomized, which means the treatment is assigned by chance, and it is double-blind, which means you and the study team do not know which treatment you receive.
If you receive lebrikizumab, the dose is 250 mg given as a subcutaneous injection, which means an injection under the skin. The treatment is given every 2 weeks for a total of 24 weeks.
If you receive the placebo, it is given on the same schedule as the active medicine, every 2 weeks for 24 weeks.
During this period, the study evaluates the effect of treatment on localized scleroderma, which is a condition that causes hardening and tightening of the skin.
Step 2
Week 24 assessment
At 24 weeks, your condition is assessed by measuring the mLoSSI score. This score is used to describe how active the skin disease is.
The main result of the study is the change in mLoSSI score from the start of the study to week 24, and this change is compared between the lebrikizumab group and the placebo group.

Who can join the trial?

8 criteria

The person must have signed and dated informed consent, which means they agreed to take part in the study before any study-related procedures are done.
The person must be an adult, meaning 18 years of age or older.
The person must have a diagnosis of localized scleroderma made by a specialist.
The diagnosis must be plaque-type or generalized localized scleroderma. Plaque-type means one or more flat or raised patches; generalized means the skin changes are spread over a wider area.
The disease must have shown active signs within the last 6 months, meaning the affected areas have grown in size and there is visible erythema, which means redness of the skin.
The person must have at least one active lesion, meaning at least one area of affected skin that is still active and not fully stable.
The person must have had an insufficient response to potent topical steroid therapy for more than 3 months. This means strong steroid cream or ointment applied to the skin did not work well enough after being used for over 3 months.
The person must have a baseline mLoSSI of 5 or higher. mLoSSI is a score used by doctors to measure how active the skin disease is at the start of the study.

Who cannot join the trial?

16 criteria

Having active rheumatoid arthritis that needs treatment and may interfere with the study medicine. Rheumatoid arthritis is a long-term disease that causes painful and swollen joints.
Planning to use any not allowed medicine or therapy, or not having the required washout period for a banned medicine. A washout period is the time needed after stopping a treatment so it can clear from the body.
Having liver cirrhosis or chronic hepatitis of any cause. Cirrhosis means permanent scarring of the liver. Hepatitis means liver inflammation.
Being pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study.
Being a woman who can become pregnant and not willing to use highly effective birth control before the first dose, during the study, and for at least 30 days after the last dose.
Having abnormal blood test results that the investigator thinks are clinically significant. This means the test results are important enough to suggest a health problem.
Being in a dependent or employment relationship with the sponsor, investigator, or study site.
Being placed in an institution by court order or official order.
Having active systemic lupus erythematosus that needs treatment and may interfere with the study medicine. Systemic lupus erythematosus is an autoimmune disease that can affect many organs.
Having had treatment with immunosuppressants, JAK inhibitors, or other biologic medicines within the last 8 weeks. Immunosuppressants lower the activity of the immune system. JAK inhibitors are medicines that block certain signals in the immune system. Biologic medicines are treatments made from living cells.
Having used topical cortisone, topical calcineurin inhibitors, or topical vitamin D within the last 2 weeks. Topical means applied to the skin.
Having severe cardiovascular disease. Cardiovascular disease means serious problems with the heart or blood vessels.
Having had UV therapy within the last 8 weeks. UV therapy uses ultraviolet light as a treatment.
Having a known allergy or hypersensitivity to the active ingredient or any ingredient in the study medicine. Hypersensitivity means the body reacts badly to a substance.
Having a current or long-term infection that needs treatment through the whole body, lasts more than 6 weeks, or keeps coming back, such as hepatitis virus infection, or having a history of HIV infection or a positive HIV test.
Having had previous treatment with a biologic medicine that targets the IL-13 pathway, such as dupilumab, tralokinumab, or lebrikizumab. The IL-13 pathway is a signal system in the immune response.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Medical Center - University Of Freiburg
Freiburg Im Breisgau, Germany
Verified
Technische Universitaet Dresden
Dresden, Germany

Trial locations

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Investigated drugs

Lebrikizumab is the study medicine being tested in this trial. It is given as an injection under the skin and is being studied to see whether it can reduce the signs and symptoms of moderate to severe localized scleroderma and improve the condition over time.

Lebrikizumab

What is already known about the treatment

Lebrikizumab - Lebrikizumab is given as a solution for injection under the skin, usually in a pre-filled syringe, and it is used in controlled clinical studies as well as in some approved skin-related treatments. It is a monoclonal antibody that blocks interleukin-13, a signal in the immune system that can drive inflammation and tissue changes. It is being studied for inflammatory skin and connective tissue diseases, including localized scleroderma, to see whether it can reduce disease activity and improve skin symptoms.

Investigated diseases

Localized scleroderma - Localized scleroderma is a condition in which the skin and sometimes the tissue under it become thick, hard, and tight in limited areas of the body. It usually begins as red, purple, or shiny patches that slowly change into firmer, paler, or darker areas. Over time, the affected skin can become less flexible and may feel bound down to the deeper tissue. In some people, the patches spread or deepen before they later become less active.