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.
- Diseases
- Atopic dermatitis (eczema)
- 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
Sites (82)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Not yet recruiting |
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Not yet recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| St. Josef Hospital Coordinator of this site? Confirm its status | Bochum | Germany | Not yet recruiting |
| Universitaetsklinikum Koeln AöR Coordinator of this site? Confirm its status | Cologne | Germany | Not yet recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Not yet recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Not yet recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Not yet recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Not yet recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Not yet recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Not yet recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Not yet recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Not yet recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Not yet recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Not yet recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Not yet recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Not yet recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Coordinator of this site? Confirm its status | Munich | Germany | Not yet recruiting |
| LMU Klinikum Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Not yet recruiting |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Not yet recruiting |
| Rostock University Medical Center Coordinator of this site? Confirm its status | Rostock | Germany | Not yet recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Not yet recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Not yet recruiting |
| Copenhagen University Hospital Coordinator of this site? Confirm its status | Copenhagen Nv | Denmark | Not yet recruiting |
| Region Syddanmark Coordinator of this site? Confirm its status | Odense C | Denmark | Not yet recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Not yet recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Not yet recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Not yet recruiting |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Not yet recruiting |
| Hospital General de Granollers Coordinator of this site? Confirm its status | Granollers | Spain | Not yet recruiting |
| El Hospital Universitario De Gran Canaria Dr. Negrin Coordinator of this site? Confirm its status | Las Palmas De Gran Canaria | Spain | Not yet recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Not yet recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Not yet recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Not yet recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Not yet recruiting |
| Complexo Hospitalario Universitario de Pontevedra Coordinator of this site? Confirm its status | Pontevedra | Spain | Not yet recruiting |
| Complejo Asistencial Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Not yet recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Not yet recruiting |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Not yet recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Not yet recruiting |
| Consorcio Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Hospital Arnau de Vilanova de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Not yet recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Not yet recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Not yet recruiting |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans Cedex 9 | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| Centre Hospitalier de Niort Coordinator of this site? Confirm its status | Niort | France | Not yet recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Not yet recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Not yet recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Not yet recruiting |
| HIA Sainte Anne Coordinator of this site? Confirm its status | Toulon Cedex 9 | France | Not yet recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Not yet recruiting |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p Coordinator of this site? Confirm its status | Wroclaw | Poland | Not yet recruiting |
| Unidade Local De Saude De Almada-Seixal E.P.E. Coordinator of this site? Confirm its status | Almada | Portugal | Not yet recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Not yet recruiting |
| Unidade Local De Saude Do Alto Ave E.P.E. Coordinator of this site? Confirm its status | Guimaraes | Portugal | Not yet recruiting |
| Unidade Local De Saude Da Regiao De Leiria E.P.E. Coordinator of this site? Confirm its status | Leiria | Portugal | Not yet recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Not yet recruiting |
| Unidade Local De Saude De Santo Antonio E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.