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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Charite Universitaetsmedizin Berlin KöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2026-05-08

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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

Secondary objectives 4

1. To evaluate the efficacy of 250 mg Q2W lebrikizumab compared to a placebo on health-related quality of life and disease activity
2. To evaluate the safety of 250 mg Q2W lebrikizumab compared to a placebo
3. To characterize the peripheral T cell profile
4. To characterize the local inflammation/sclerosis of affected skin areas

Conditions and MedDRA coding

Localized Scleroderma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Signed and dated informed consent has been obtained prior to any protocol-related procedures.
2. Baseline mLossi ≥5
3. Adults, aged ≥18 years
4. 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
5. Insufficient response to potent topical steroid therapy for >3 months

Exclusion criteria 16

1. Active rheumatoid arthritis that requires treatment, which interferes with the IMP
2. Active systemic lupus erythematosus (SLE) that requires treatment, which interferes with IMP
3. Previous treatment with immunosuppressants, JAK-inhibitors and/or other biologics within the last 8 weeks
4. Previous treatment with topical cortisone, topical calcineurininhibitors and topical vitamin d within the last 2 weeks
5. Severe cardiovascular disease
6. UV therapy within the last 8 weeks
7. Hypersensitivity to the active ingredient or ingredients of the preparation
8. 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
9. Previous treatment with biologic targeting IL-13 pathway (dupilumab or tralokinumab or lebrikizumab)
10. 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
11. Known liver cirrhosis and/or chronic hepatitis of any etiology
12. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
13. 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
14. In the Investigator’s opinion, any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit
15. Potential subjects who are in a dependent/employment relationship with the sponsor, investigator or clinical trial site
16. Potential subjects who are placed in an institution due to a court or official order

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. mLoSSI score after 24 weeks. Absolute change from baseline visit in mLoSSI score will be compared between groups

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Charite Universitaetsmedizin Berlin KöR

Sponsor organisation

Charite Universitaetsmedizin Berlin KöR

Address

Chariteplatz 1, Mitte Mitte

City

Berlin

Postcode

10117

Country

Germany

Scientific contact point

Organisation

Charite Universitaetsmedizin Berlin KöR

Contact name

Philipp Globig

Public contact point

Organisation

Charite Universitaetsmedizin Berlin KöR

Contact name

Philipp Globig

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications