Atopic DermatitisPhase 3ADfaceNCT07873801
A Study of Lebrikizumab in Adults and Adolescents With Face and Neck Atopic Dermatitis
A Phase 3 study testing Lebrikizumab in people with Atopic Dermatitis, run by Almirall, S.A..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lebrikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jun 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Natalia Calderón contact
About this study
Official title: 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
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Lebrikizumab, Placebo
- Keywords
- Facial eczema, Face-IGA, Lebrikizumab, Face and neck atopic dermatitis, Visible disease burden, Psychosocial impact and stigmatization, IL-13 inhibition, Pathophysiology of facial AD, Face and neck microbiota, Facial biomarkers, Standardized photography in AD
- Medical subject headings
- Dermatitis, Atopic, Facies, Stereotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LebrikizumabDrug
Lebrikizumab SC injection.
PlaceboOther
Matching placebo SC injection.
LebrikizumabDrug
Lebrikizumab for the Placebo-controlled Period who were either responders or non-responders to lebrikizumab treatment at Week 16 will receive lebrikizumab SC injection.
LebrikizumabDrug
Placebo for the Placebo-controlled Period will begin lebrikizumab treatment at Week 16 and will receive lebrikizumab SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Placebo-controlled Period: Lebrikizumab | Experimental | Not described Receives: Drug: Lebrikizumab |
| Placebo-controlled Period: Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Blinded Extension Period: Placebo-controlled Period (Lebrikizumab) to Lebrikizumab | Experimental | Not described Receives: Drug: Lebrikizumab |
| Blinded Extension Period: Placebo-controlled Period (Placebo) to Lebrikizumab | Experimental | Not described Receives: Drug: Lebrikizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: At Week 16
Secondary outcomes (11)
Percentage of Participants with Dermatology Life Quality Index (DLQI) >= 4 Points at Baseline Achieving DLQI >=4-point Improvement from Baseline 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.
Measured: At Week 16
Percentage Change from Baseline at Week 16 in Local SCORing AD (SCORAD)
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).
Measured: Baseline, Week 16
Proportion of Participants who are "Satisfied" or "Very Satisfied" on Face and Neck Atopic Dermatitis Clearance Satisfaction (FNADCS) 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).
Measured: At Week 16
Percentage Change from Baseline to Week 16 in Face Pruritus Numerical Rating Scale (NRS)
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 ".
Measured: Baseline, Week 16
Absolute Change from Baseline in Work Productivity and Activity Impairment (WPAI) Index to 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.
Measured: Baseline, Week 16
Percentage Change from Baseline to Week 16 in Sleep-Loss Scale
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).
Measured: Baseline, Week 16
Percentage of Participants Achieving F-IGA Score of 0 or 1 and a Reduction >=2 points from Baseline 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.
Measured: At Week 32
Percentage Change from Baseline to Week 32 in Local SCORAD
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).
Measured: Baseline, Week 32
Percentage of Participants with DLQI >=4 at Baseline Achieving DLQI >= 4-point Improvement from Baseline 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.
Measured: At Week 32
Percentage Change from Baseline to Week 32 in Face Pruritus NRS
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 ".
Measured: Baseline, Week 32
Percentage Change from Baseline to Week 32 in Sleep-Loss Scale
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).
Measured: Baseline, Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of a 16-week placebo-controlled period followed by a 16-week blinded extension period.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Almirall, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873801
- Sponsor's protocol ID
- M-17923-36
- Other IDs
- 2025-525133-31-00, 2025
- Acronym
- ADface
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No