A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 250 mg lebrikizumab in patients with localized scleroderma (LEMO)

Prior treatment

• 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
• 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
• 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
• UV therapy within the last 8 weeks
• Previous treatment with biologic targeting IL-13 pathway (dupilumab or tralokinumab or lebrikizumab)

Other illness

• Known liver cirrhosis and/or chronic hepatitis of any etiology
• Severe cardiovascular disease
• 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

Lab values

• In the Investigator’s opinion, any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit

Other

• Active rheumatoid arthritis that requires treatment, which interferes with the IMP
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
• 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

• 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