A Phase 3 interventional study of Lebrikizumab and Placebo in Atopic Dermatitis, sponsored by Almirall, S.A.. Not yet recruiting. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Almirall, S.A. · Phase 3, Interventional, and Treatment
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.
1,444 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.
This study's planned enrollment of 230 is above the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Almirall, S.A. is the lead sponsor of 66 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants eligible for inclusion in this trial must fulfil all of the following criteria:
Exclusion Criteria:
Participants fulfilling any of the following criteria are not eligible for inclusion in this trial:
Drug: Lebrikizumab
Other: Placebo
Drug: Lebrikizumab
Drug: Lebrikizumab
Lebrikizumab SC injection.
Matching placebo SC injection.
Lebrikizumab for the Placebo-controlled Period who were either responders or non-responders to lebrikizumab treatment at Week 16 will receive lebrikizumab SC injection.
Placebo for the Placebo-controlled Period will begin lebrikizumab treatment at Week 16 and will receive lebrikizumab SC injection.
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.
Time frame: At Week 16
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.
Time frame: 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).
Time frame: 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).
Time frame: 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 ".
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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 ".
Time frame: 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).
Time frame: Baseline, Week 32
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Feb 2028, 15 months later.
Of 132 industry-sponsored phase 3 interventional studies under Dermatitis, Atopic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 26. This study's planned 15 months is below that.
Counting every sponsor, half of 139 studies reached it within 18 months; a quarter within 13 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lebrikizumab