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

• Lebrikizumab (Drug): Lebrikizumab SC injection.
• Placebo (Other): Matching placebo SC injection.
• Lebrikizumab (Drug): Lebrikizumab for the Placebo-controlled Period who were either responders or non-responders to lebrikizumab treatment at Week 16 will receive lebrikizumab SC injection.
• Lebrikizumab (Drug): Placebo for the Placebo-controlled Period will begin lebrikizumab treatment at Week 16 and will receive lebrikizumab SC injection.

Primary outcomes

• Percentage of Participants Achieving a Face-Investigator Global Assessment (F-IGA) Score of 0 or 1 and a Reduction >=2 Points from Baseline at Week 16 [At Week 16]: The F-IGA is an instrument used to rate the severity of atopic dermatitis (AD) of a participant on the face. It is a clinician-rated scale that typically ranges from 0 (clear) to 4 (severe), with specific descriptors for each point based on observable signs.

Secondary outcomes

• Percentage of Participants with Dermatology Life Quality Index (DLQI) >= 4 Points at Baseline Achieving DLQI >=4-point Improvement from Baseline at Week 16 [At Week 16]: The DLQI consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life. Each item is scored on a 4-point Likert scale (0 = 'not at all / not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). DLQI scores range from 0 to 30, with higher scores indicating worse quality of life.
• Percentage Change from Baseline at Week 16 in Local SCORing AD (SCORAD) [Baseline, Week 16]: The Local SCORAD is being used in this study to assess AD intensity on the face and neck. The intensity part of the SCORAD Index consists of 6 items: erythema, oedema, oozing/crusting, excoriation, lichenification, and dryness. Each item is graded as follows: None (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points).
• Proportion of Participants who are "Satisfied" or "Very Satisfied" on Face and Neck Atopic Dermatitis Clearance Satisfaction (FNADCS) at Week 16 [At Week 16]: FNADCS is a single-item question that assesses participants' satisfaction with face and neck clearance. Satisfaction is captured using a 5-point verbal rating scale (i.e very dissatisfied to very satisfied).
• Percentage Change from Baseline to Week 16 in Face Pruritus Numerical Rating Scale (NRS) [Baseline, Week 16]: The Face Pruritus NRS is an 11-point scale used by participants to rate the severity of the pruritus on their face over the past 24 hours. Score range from 0 to 10, where high score indicates "worst itch ".
• Absolute Change from Baseline in Work Productivity and Activity Impairment (WPAI) Index to Week 16 [Baseline, Week 16]: The WPAI Scale is a patient-reported 6-item validated questionnaire designed to assess the impact of health conditions on work productivity and daily activities over the past week. The results are presented as follows: Percentage of work time missed due to health, percentage of impairment while working due to health, percentage of overall work impairment due to health, and percentage of activity impairment due to health.
• Percentage Change from Baseline to Week 16 in Sleep-Loss Scale [Baseline, Week 16]: Participants will rate their sleep-loss on a 5-point Likert scale with scores ranging from 0 (not at all) to 4 (unable to sleep at all).
• Percentage of Participants Achieving F-IGA Score of 0 or 1 and a Reduction >=2 points from Baseline at Week 32 [At Week 32]: The F-IGA is an instrument used to rate the severity of AD of a participant on the face. It is a clinician-rated scale that typically ranges from 0 (clear) to 4 (severe), with specific descriptors for each point based on observable signs.
• Percentage Change from Baseline to Week 32 in Local SCORAD [Baseline, Week 32]: The Local SCORAD is being used in this study to assess AD intensity on the face and neck. The intensity part of the SCORAD Index consists of 6 items: erythema, oedema, oozing/crusting, excoriation, lichenification, and dryness. Each item is graded as follows: None (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points).
• Percentage of Participants with DLQI >=4 at Baseline Achieving DLQI >= 4-point Improvement from Baseline at Week 32 [At Week 32]: The DLQI consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their quality of life. Each item is scored on a 4-point Likert scale (0 = 'not at all / not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). DLQI scores range from 0 to 30, with higher scores indicating worse quality of life.
• Percentage Change from Baseline to Week 32 in Face Pruritus NRS [Baseline, Week 32]: The Face Pruritus NRS is an 11-point scale used by participants to rate the severity of the pruritus on their face over the past 24 hours. Score range from 0 to 10, where high score indicates "worst itch ".
• Percentage Change from Baseline to Week 32 in Sleep-Loss Scale [Baseline, Week 32]: Participants will rate their sleep-loss on a 5-point Likert scale with scores ranging from 0 (not at all) to 4 (unable to sleep at all).

Sex: All, ages: 12 Years to any

Inclusion Criteria:

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.

Exclusion Criteria:

Participants fulfilling any of the following criteria are not eligible for inclusion in this trial:

* 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.
* 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
* 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.
* History of human immunodeficiency virus (HIV) infection (including known positive HIV serology in medical history).
* 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.
* 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.
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

• Study Director, Study director, Almirall, S.A.

NIH grants: 2025