BridgeMD
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 250 mg lebrikizumab in patients with localized scleroderma (LEMO)
EU CTIS ID: 2025-524435-39-00
What this study is testing
To evaluate the efficacy of 250mg Q2W lebrikizumab compared to a placebo in adult patients with moderate to severe localized scleroderma after 24 weeks.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated informed consent has been obtained prior to any protocol-related procedures.
- Baseline mLossi ≥5
- Adults, aged ≥18 years
- Diagnosis of LoS by a specialist with plaque-type or generalized LoS with documented disease activity (increase in size of the lesions and a visible erythema) within the last 6 months and at least one active lesion
- Insufficient response to potent topical steroid therapy for >3 months
You likely can't join if
- Active rheumatoid arthritis that requires treatment, which interferes with the IMP
- Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication
- Known liver cirrhosis and/or chronic hepatitis of any etiology
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
- Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 30 days after the last dose
- In the Investigator’s opinion, any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit
See the full eligibility criteria
- Signed and dated informed consent has been obtained prior to any protocol-related procedures.
- Baseline mLossi ≥5
- Adults, aged ≥18 years
- Diagnosis of LoS by a specialist with plaque-type or generalized LoS with documented disease activity (increase in size of the lesions and a visible erythema) within the last 6 months and at least one active lesion
- Insufficient response to potent topical steroid therapy for >3 months
- Active rheumatoid arthritis that requires treatment, which interferes with the IMP
- Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication
- Known liver cirrhosis and/or chronic hepatitis of any etiology
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
- Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 30 days after the last dose
- In the Investigator’s opinion, any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit
- Potential subjects who are in a dependent/employment relationship with the sponsor, investigator or clinical trial site
- Potential subjects who are placed in an institution due to a court or official order
- Active systemic lupus erythematosus (SLE) that requires treatment, which interferes with IMP
- Previous treatment with immunosuppressants, JAK-inhibitors and/or other biologics within the last 8 weeks
- Previous treatment with topical cortisone, topical calcineurininhibitors and topical vitamin d within the last 2 weeks
- Severe cardiovascular disease
- UV therapy within the last 8 weeks
- Hypersensitivity to the active ingredient or ingredients of the preparation
- Known current or chronic infections (requiring systemic treatment or with duration above 6 weeks or recurring) e.g., hepatitis virus, or history of human immunodeficiency virus (HIV) infection or known positive HIV serology
- Previous treatment with biologic targeting IL-13 pathway (dupilumab or tralokinumab or lebrikizumab)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.