A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 250 mg lebrikizumab in patients with localized scleroderma (LEMO)
Key facts
- Where
- Berlin, Dresden, Erlangen, Freiburg im Breisgau, Oberhausen és Tuebingen, NémetországSee the 6 sites
- Phase
- 2. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországToborzás még nem indult
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, NémetországToborzás még nem indult
- Universitaetsklinikum Erlangen AöRErlangen, NémetországToborzás még nem indult
- Medical Center- University of FreiburgFreiburg im Breisgau, NémetországToborzás még nem indult
- HELIOS St. Elisabeth Klinik Oberhausen GmbHOberhausen, NémetországToborzás még nem indult
- Eberhard Karls Universitaet TuebingenTuebingen, NémetországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Charite Universitaetsmedizin Berlin KöR
- Trial code
- EU 2025-524435-39-00
- Record updated
- 2026. július 3.
- Original description
To evaluate the efficacy of 250mg Q2W lebrikizumab compared to a placebo in adult patients with moderate to severe localized scleroderma after 24 weeks.Read full original descriptionShow less
To evaluate the efficacy of 250mg Q2W lebrikizumab compared to a placebo in adult patients with moderate to severe localized scleroderma after 24 weeks.
Inclusion: 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.
Exclusion: 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); 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; In the Investigator’s opinion, any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit; 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.