LEBRIKIZUMAB for Localized scleroderma

Inclusion criteria

• {"criterion_text":"- Signed and dated informed consent has been obtained prior to any protocol-related procedures."}
• {"criterion_text":"- Baseline mLossi ≥5"}
• {"criterion_text":"- Adults, aged ≥18 years"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Insufficient response to potent topical steroid therapy for >3 months"}

Exclusion criteria

• {"criterion_text":"- Active rheumatoid arthritis that requires treatment, which interferes with the IMP"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Known liver cirrhosis and/or chronic hepatitis of any etiology"}
• {"criterion_text":"- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- In the Investigator’s opinion, any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit"}
• {"criterion_text":"- Potential subjects who are in a dependent/employment relationship with the sponsor, investigator or clinical trial site"}
• {"criterion_text":"- Potential subjects who are placed in an institution due to a court or official order"}
• {"criterion_text":"- Active systemic lupus erythematosus (SLE) that requires treatment, which interferes with IMP"}
• {"criterion_text":"- Previous treatment with immunosuppressants, JAK-inhibitors and/or other biologics within the last 8 weeks"}
• {"criterion_text":"- Previous treatment with topical cortisone, topical calcineurininhibitors and topical vitamin d within the last 2 weeks"}
• {"criterion_text":"- Severe cardiovascular disease"}
• {"criterion_text":"- UV therapy within the last 8 weeks"}
• {"criterion_text":"- Hypersensitivity to the active ingredient or ingredients of the preparation"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Previous treatment with biologic targeting IL-13 pathway (dupilumab or tralokinumab or lebrikizumab)"}

Primary endpoints

• {"endpoint_text":"- mLoSSI score after 24 weeks. Absolute change from baseline visit in mLoSSI score will be compared between groups","definition_or_measurement_approach":"Absolute change from baseline in mLoSSI score at 24 weeks; comparison between treatment and placebo groups."}

Germany

Earliest CTIS Part Ii Submission Date

27-04-2026

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

11

Number Of Sites

6

Number Of Participants

78

Primary sponsor

Full Name

Charite Universitaetsmedizin Berlin KöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany