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Efficacy and Safety of Lebrikizumab in Adults and Adolescents with Moderate-to-Severe Face and Neck Atopic Dermatitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at people with moderate-to-severe Face and Neck Atopic Dermatitis, a skin condition that causes red, itchy, and inflamed patches on the face and neck. The investigational medicine being tested is lebrikizumab, which is given as a subcutaneous injection. Some participants will receive a harmless solution called placebo instead of the active drug, so that the researchers can compare results.

The aim of the trial is to see whether lebrikizumab improves skin appearance and reduces itching better than the placebo after 16 weeks. Participants will be randomly assigned to one of the two groups, and neither the participants nor the doctors will know which treatment is being given, making it a double-blind study. During the 16‑week period, they will attend regular clinic visits where doctors will check the skin using a simple rating scale (the IGA score) that rates severity from clear to severe, and they will also answer questions about how the skin affects daily life (DLQI) and have the affected area measured with a scoring system called SCORAD.

Safety will be monitored throughout the study, and any side effects will be recorded. After the 16‑week assessment, participants may continue to be followed for additional safety checks. The overall goal is to determine if the new treatment is both effective and safe for people with this type of skin condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After joining the study, a visit is scheduled to confirm eligibility and collect baseline information about the skin condition.

    During this visit, the severity of face and neck atopic dermatitis is recorded and quality‑of‑life questionnaires are completed.

  2. Step 2

    Randomisation and first injection

    Participants are randomly assigned to receive either lebrikizumab or a matching placebo injection.

    The assigned product is a 250 mg solution for injection that is given by subcutaneous injection (under the skin).

  3. Step 3

    Study visits and ongoing injections

    Follow‑up visits are arranged at regular intervals during the first 16 weeks of the trial.

    At each visit, the same type of injection (either lebrikizumab or placebo) is administered according to the study schedule.

    During these visits the skin condition is re‑evaluated and any side effects are recorded.

  4. Step 4

    Week 16 evaluation

    At week 16, the primary assessment is performed to determine whether the participant achieved an IGA score of 0 or 1 with a reduction of at least 2 points from baseline.

    Secondary assessments include the change in quality‑of‑life score (DLQI) and the change in SCORAD score, which measures the extent and severity of dermatitis.

  5. Step 5

    Study completion and final assessment

    After the week 16 visit, a final study visit is conducted to collect any remaining safety information and to conclude participation in the trial.

Who can join the trial?

8 criteria

  • Adults and adolescents (aged 12 years or older but under 18 years) who weigh at least 40 kg and are candidates for systemic therapy (medicine that works throughout the whole body) for atopic dermatitis.
  • Have chronic atopic dermatitis that meets the Hanifin and Rajka criteria (a set of signs doctors use to diagnose this condition) and has been present for at least one year before the screening visit.
  • Have moderate facial and neck atopic dermatitis as judged by an Investigator Global Assessment (IGA) score of 3 or higher at screening and baseline (the IGA is a doctor’s rating of overall severity from 0 = clear to 4 = severe).
  • Have an Eczema Area and Severity Index (EASI) score of 12 or higher at baseline, with clear eczema lesions in at least one area of the body other than the face and neck (the EASI measures how much skin is affected and how severe it is).
  • The doctor believes that previous treatment with topical corticosteroids (TCS) (creams or ointments that reduce inflammation) did not work well enough.
  • Completed a daily itch rating using a Pruritus Numeric Rating Scale (NRS) recorded in an electronic diary (eDiary) for at least four of the seven days immediately before the baseline visit (the Pruritus NRS is a scale from 0 = no itch to 10 = worst itch).
  • Agree to follow general skin‑care steps to keep skin from getting dry or irritated, such as using moisturizers regularly, avoiding known irritants, not using new soaps or cosmetics on the face and neck, avoiding cosmetic procedures on the face/neck, and using gentle skin‑care (lukewarm baths, patting skin dry).
  • Women who could become pregnant (women of childbearing potential) must agree to either avoid heterosexual intercourse or use a highly effective birth‑control method during the study and for at least four weeks after the last dose of the study drug (investigational medicinal product, IMP).

Who cannot join the trial?

19 criteria

  • Have taken lebrikizumab before the study.
  • Have taken more than one of the following strong systemic medicines at any time: dupilumab, tralokinumab, nemolizumab, or oral JAK inhibitors (pills that affect the immune system).
  • Show skin signs that look like psoriasis (such as nail pits, scalp, hand, foot, or skin‑fold involvement) or have a personal history of psoriasis or psoriatic arthritis.
  • Have other skin problems on the face or neck that could interfere with study measurements, such as rosacea, flushing, demodicosis (tiny skin mites), or seborrheic dermatitis (scaly skin).
  • Have suspected or confirmed contact dermatitis of the face or neck caused by an allergen that cannot be avoided.
  • Had any serious, opportunistic, chronic (lasting 6 weeks or more), or recurring infection within 3 months before screening, or develop one before the first study visit. (Serious infection means hospitalization or IV/strong antibiotics; opportunistic infection means an infection that occurs when the immune system is weakened.)
  • Have an active or high‑risk infection caused by parasites (worms or similar organisms).
  • Taken systemic (whole‑body) antibiotics, antivirals, antiparasitics, or antifungals for an active infection within 2 weeks before the first visit, or used topical (skin) versions within 1 week.
  • Have a history of human immunodeficiency virus (HIV) infection (positive HIV test).
  • Have a known or suspected history of immunosuppression, including past serious opportunistic infections.
  • Plan to use any medication or therapy that is not allowed by the study, or cannot stop a prohibited medicine for the required wash‑out period (time needed for a drug to leave the body).
  • Are allergic (hypersensitivity) to any part of lebrikizumab.
  • Have an uncontrolled chronic disease that might require systemic corticosteroids (strong anti‑inflammatory medicines taken by mouth or injection), such as uncontrolled asthma (defined as two or more asthma attacks in the past year needing oral or injected steroids or a hospital stay > 24 hours).
  • Have known liver cirrhosis (severe liver scarring) or chronic hepatitis (long‑term liver inflammation) of any cause, or test positive for hepatitis B or C.
  • Show any clinically significant abnormality at the screening visit that the investigator believes is important.
  • Have had a malignancy (cancer) within the past 5 years, except for fully treated in‑situ cervical carcinoma or completely treated non‑metastatic skin cancers (squamous or basal cell) with no recurrence in the past 12 weeks.
  • Have a severe illness that the investigator thinks would make participation unsafe or unreliable, or any other medical or psychological condition that could pose an unreasonable risk or interfere with study assessments.
  • Are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
  • Are an employee or close relative of employees at the study centre, the sponsor (Almirall), any third‑party organization involved in the study, or are under a legal order that requires participation.
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Investigated drugs

Lebrikizumab is an investigational medicine being tested to see if it can improve moderate‑to‑severe atopic dermatitis on the face and neck. In the study participants receive the drug as a sterile liquid that is injected just under the skin (subcutaneous injection). The researchers are checking how well the medicine works and whether it is safe compared with a placebo over a 16‑week period.

What is already known about the treatment

Lebrikizumab - Lebrikizumab is given as a sterile solution for subcutaneous injection, usually in a pre‑filled syringe. It is an approved humanized monoclonal antibody that targets the immune protein interleukin‑13, stopping the signal that leads to skin inflammation. The drug is used to treat moderate‑to‑severe atopic dermatitis, including facial and neck involvement, and is widely reported in clinical studies and product labeling. It belongs to the class of immunomodulating antibodies that modify the body’s inflammatory response.

Investigated diseases

Facial and neck atopic dermatitis - Atopic dermatitis is a chronic inflammatory skin condition that causes red, itchy patches. When it affects the face and neck, it leads to dry, scaly lesions in those areas. The condition tends to flare up, with periods of worsening symptoms followed by quieter phases. Over time, the skin may become thicker and more vulnerable to irritation. Persistent scratching can worsen the appearance and cause discomfort.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-525133-31-00Protocol codeM-17923-36Estimated enrolment286 patientsSponsorAlmirall S.A.

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