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NCT07873801Not yet recruitingPhase 3

A Study of Lebrikizumab in Adults and Adolescents With Face and Neck Atopic Dermatitis

A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Face and Neck Atopic Dermatitis

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

The main aim of the study is to evaluate the efficacy and safety of lebrikizumab treatment for up to 32 weeks in participants with moderate-to-severe face and neck atopic dermatitis (FNAD) who also have moderate-to-severe AD outside of the face and neck region, and who are in need of systemic therapy.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
230 (estimated)
First submitted
8 Oct 2026
Start date
1 Nov 2026
Primary completion date
29 Feb 2028
Lead sponsor
Almirall, S.A.
NCT number
NCT07873801
EU CT number
2025-525133-31-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 230
  • From 1 Nov 2026 to the primary completion date, 29 Feb 2028
  • 82 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with lebrikizumab.
  • Prior treatment at any time with more than one of the following advanced systemic treatments: Dupilumab, tralokinumab, nemolizumab, or oral JAK inhibitors.
  • 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.

Other illness

  • Presence of dermatological conditions and/or skin signs or symptoms on the face and/or neck that may interfere with study assessments including but not limited to rosacea, flushing, demodicosis, and seborrheic dermatitis
  • History of human immunodeficiency virus (HIV) infection (including known positive HIV serology in medical history).
  • Uncontrolled chronic disease that might require use of systemic corticosteroids, eg, uncontrolled asthma.
  • Known liver cirrhosis and/or chronic hepatitis of any aetiology and/or current infection (at Screening) with hepatitis B or hepatitis C.
  • History of malignancy, including mycosis fungoides, within 5 years before the Screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.

Other

  • Participants fulfilling any of the following criteria are not eligible for inclusion in this trial:
  • Participants with suspected clinically relevant contact dermatitis of the face and neck region, and participants with a confirmed contact allergen known to exacerbate their atopic dermatitis who cannot commit to allergen avoidance or when allergen avoidance is not possible.
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Who the study is looking for

  • Participants eligible for inclusion in this trial must fulfil all of the following criteria:
  • Adults and adolescents (aged \[greater than or equal to (\>=)\] 12 years to \[less than (\<)\]18 years at the time of informed consent form \[ICF\]/informed assent form \[IAF\] signature and weighing \>=40 kilograms \[kg\]) who are candidates for AD systemic therapy.
  • Chronic AD (according to Hanifin and Rajka Criteria (Hanifin 1980)) that has been present for \>=1 year before the Screening visit.
  • At least moderate FNAD with F-IGA \>=3 (scale of 0 \[clear\] to 4 \[severe\]) at Screening and Day 1/Baseline.
  • Overall EASI score \>=12 at Day 1/Baseline with distinct atopic dermatitis lesions in at least one area outside the face and neck.

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (82)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitaetsklinikum Augsburg
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AugsburgGermanyNot yet recruiting
Thermalsole und Schwefelbad Bentheim GmbH
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Bad BentheimGermanyNot yet recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyNot yet recruiting
St. Josef Hospital
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BochumGermanyNot yet recruiting
Universitaetsklinikum Koeln AöR
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CologneGermanyNot yet recruiting
Technische Universitaet Dresden
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DresdenGermanyNot yet recruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyNot yet recruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyNot yet recruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyNot yet recruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyNot yet recruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyNot yet recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyNot yet recruiting
Medizinische Hochschule Hannover
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HanoverGermanyNot yet recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyNot yet recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyNot yet recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyNot yet recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyNot yet recruiting
Universitaet Muenster
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MuensterGermanyNot yet recruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
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MunichGermanyNot yet recruiting
LMU Klinikum Muenchen AöR
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MunichGermanyNot yet recruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyNot yet recruiting
Rostock University Medical Center
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RostockGermanyNot yet recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyNot yet recruiting
Region Midtjylland
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Aarhus NDenmarkNot yet recruiting
Copenhagen University Hospital
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Copenhagen NvDenmarkNot yet recruiting
Region Syddanmark
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Odense CDenmarkNot yet recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainNot yet recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainNot yet recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainNot yet recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainNot yet recruiting
Hospital del Mar
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BarcelonaSpainNot yet recruiting
Hospital Universitario Basurto
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BilbaoSpainNot yet recruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainNot yet recruiting
Hospital Universitario Clínico San Cecilio
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GranadaSpainNot yet recruiting
Hospital General de Granollers
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GranollersSpainNot yet recruiting
El Hospital Universitario De Gran Canaria Dr. Negrin
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Las Palmas De Gran CanariaSpainNot yet recruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainNot yet recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainNot yet recruiting
Hospital Universitario La Paz
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MadridSpainNot yet recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainNot yet recruiting
Hospital Universitario 12 de Octubre
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MadridSpainNot yet recruiting
Hospital Universitario de la Princesa
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MadridSpainNot yet recruiting
Hospital Universitario Infanta Leonor
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MadridSpainNot yet recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainNot yet recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainNot yet recruiting
University Hospital Son Espases
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PalmaSpainNot yet recruiting
Complexo Hospitalario Universitario de Pontevedra
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PontevedraSpainNot yet recruiting
Complejo Asistencial Universitario de Salamanca
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SalamancaSpainNot yet recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainNot yet recruiting
Hospital Universitario Virgen De Valme
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SevillaSpainNot yet recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainNot yet recruiting
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainNot yet recruiting
Hospital Arnau de Vilanova de Valencia
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ValenciaSpainNot yet recruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainNot yet recruiting
Hospital Universitario Miguel Servet
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ZaragozaSpainNot yet recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceNot yet recruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceNot yet recruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceNot yet recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceNot yet recruiting
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceNot yet recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceNot yet recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceNot yet recruiting
Centre Hospitalier de Niort
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NiortFranceNot yet recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceNot yet recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceNot yet recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceNot yet recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceNot yet recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceNot yet recruiting
Centre Hospitalier Universitaire Rouen
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Rouen CedexFranceNot yet recruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceNot yet recruiting
HIA Sainte Anne
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Toulon Cedex 9FranceNot yet recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandNot yet recruiting
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
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RzeszówPolandNot yet recruiting
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
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WarsawPolandNot yet recruiting
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
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WroclawPolandNot yet recruiting
Unidade Local De Saude De Almada-Seixal E.P.E.
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AlmadaPortugalNot yet recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalNot yet recruiting
Unidade Local De Saude Do Alto Ave E.P.E.
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GuimaraesPortugalNot yet recruiting
Unidade Local De Saude Da Regiao De Leiria E.P.E.
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LeiriaPortugalNot yet recruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalNot yet recruiting
Unidade Local de Saude de Sao Joao E.P.E.
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PortoPortugalNot yet recruiting
Unidade Local De Saude De Santo Antonio E.P.E.
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PortoPortugalNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.