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Not yet taking people in GermanyPhase 2

Lebrikizumab compared with placebo for adults with localized scleroderma

Tests lebrikizumab against placebo in adults with moderate to severe localized scleroderma.

Key facts

Who runs it
Charite Universitaetsmedizin Berlin KöR
Where
Berlin, Dresden, Erlangen, Freiburg im Breisgau, Oberhausen, and Tuebingen, GermanySee the 6 sites
Registry title
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 250 mg lebrikizumab in patients with localized scleroderma (LEMO)
Status
Not yet recruiting
Phase
Phase 2
People taking part
78 people, planned
Started
30 Apr 2026
Expected to end
31 Mar 2028
Type of study
Interventional
Record updated
3 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate to severe localized scleroderma who did not respond well to strong steroid creams. They get lebrikizumab or a placebo for 24 weeks.

Age
18 years or older
Sex
Men and women
Disease stage
Plaque-type or generalized localized scleroderma, with disease activity in the last 6 months (lesions growing and visibly red) and at least one active lesion. Baseline mLossi of 5 or more.
Earlier treatment
Must have had an insufficient response to potent topical steroid therapy for more than 3 months. Must not have had immunosuppressants, JAK-inhibitors or other biologics in the last 8 weeks, UV therapy in the last 8 weeks, or topical cortisone, topical calcineurin inhibitors or topical vitamin D in the last 2 weeks. Must not have had treatment with dupilumab, tralokinumab or lebrikizumab.

Main reasons for not taking part

  • Pregnant or breastfeeding women, or women planning pregnancy or breastfeeding during the study
  • Known liver cirrhosis or chronic hepatitis
  • History of HIV infection or a positive HIV test
  • Active rheumatoid arthritis or active systemic lupus erythematosus that needs treatment
  • Severe cardiovascular disease

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Germany

  • Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNot yet recruiting
  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyNot yet recruiting
  • Universitaetsklinikum Erlangen AöRErlangen, GermanyNot yet recruiting
  • Medical Center- University of FreiburgFreiburg im Breisgau, GermanyNot yet recruiting
  • HELIOS St. Elisabeth Klinik Oberhausen GmbHOberhausen, GermanyNot yet recruiting
  • Eberhard Karls Universitaet TuebingenTuebingen, GermanyNot yet recruiting

About the trial

What the trial wants to find out

To evaluate the efficacy of 250mg Q2W lebrikizumab compared to a placebo in adult patients with moderate to severe localized scleroderma after 24 weeks.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 250 mg lebrikizumab in patients with localized scleroderma (LEMO)
Plain-language title
Lebrikizumab compared with placebo for adults with localized sclerodermaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
3 July 2026