18 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Change From Baseline in Eczema Area and Severity Index (EASI)Primary· Baseline, Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and
Group
Value
95% CI
125 mg Lebrikizumab (Q4W)
-62.34
± 37.266
250 mg Lebrikizumab (Q4W)
-69.21
± 38.282
250 mg Lebrikizumab (Q2W)
-72.09
± 37.229
Placebo
-41.12
± 59.496
Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16Secondary· Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and
Group
Value
95% CI
125 mg Lebrikizumab (Q4W)
43.3
250 mg Lebrikizumab (Q4W)
56.1
250 mg Lebrikizumab (Q2W)
60.6
Placebo
24.3
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥2 Points From Baseline to Week 16 (5-point Scale)Secondary· Week 16
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Group
Value
95% CI
125 mg Lebrikizumab (Q4W)
26.6
250 mg Lebrikizumab (Q4W)
33.7
250 mg Lebrikizumab (Q2W)
44.6
Placebo
15.3
Percentage of Participants With EASI <7 at Week 16Secondary· Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and
Group
Value
95% CI
125 mg Lebrikizumab (Q4W)
42.2
250 mg Lebrikizumab (Q4W)
61.2
250 mg Lebrikizumab (Q2W)
61.8
Placebo
29.3
Percentage of Participants Achieving EASI50 at Week 16Secondary· Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and
Group
Value
95% CI
125 mg Lebrikizumab (Q4W)
66.4
250 mg Lebrikizumab (Q4W)
77.0
250 mg Lebrikizumab (Q2W)
81.0
Placebo
45.8
Percentage of Participants Achieving EASI90 at Week 16Secondary· Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and
Group
Value
95% CI
125 mg Lebrikizumab (Q4W)
26.1
250 mg Lebrikizumab (Q4W)
36.1
250 mg Lebrikizumab (Q2W)
44.0
Placebo
11.4
Percent Change From Baseline in the Sleep Loss Scale ScoreSecondary· Baseline, Week 16
The Sleep Loss Scale is used by the participants to report the impact of itching on their sleep every night. Participants responded to the question to what extent did your itching interfere with your sleep last night. The scale ranged from 0 to 4, with 0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments were recorded daily by the participant using an electronic diary.
Least Squares (LS) Means were calculated using ANCOVA with the factor of treatment and the baseline sleep-loss scale as covariates.
Group
Value
95% CI
125 mg Lebrikizumab (Q4W)
-48.68
± 50.692
250 mg Lebrikizumab (Q4W)
-53.03
± 50.662
250 mg Lebrikizumab (Q2W)
-64.69
± 50.692
Placebo
-20.24
± 51.066
Percent Change From Baseline in Pruritus Numeric Rating Score (NRS)Secondary· Baseline, Week 16
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Pruritus assessments were recorded daily by the participant using an electronic diary.
LS Means were calculated using ANCOVA with the factor of treatments and the baseline pruritus NRS as covariates.
Group
Value
95% CI
125 mg Lebrikizumab (Q4W)
-35.94
± 55.553
250 mg Lebrikizumab (Q4W)
-49.60
± 55.555
250 mg Lebrikizumab (Q2W)
-60.63
± 55.564
Placebo
4.26
± 55.610
Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16Secondary· Week 16
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary.
The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 3-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.
Group
Value
95% CI
125 mg Lebrikizumab (Q4W)
50.9
250 mg Lebrikizumab (Q4W)
64.9
250 mg Lebrikizumab (Q2W)
76.0
Placebo
45.5
Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16Secondary· Week 16
The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary.
The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 4-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.
Group
Value
95% CI
125 mg Lebrikizumab (Q4W)
41.8
250 mg Lebrikizumab (Q4W)
47.4
250 mg Lebrikizumab (Q2W)
70.0
Placebo
27.3
Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)Secondary· Baseline, Week 16
The body surface area (BSA) affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including a
Group
Value
95% CI
125 mg Lebrikizumab (Q4W)
-19.6
± 19.08
250 mg Lebrikizumab (Q4W)
-24.9
± 20.08
250 mg Lebrikizumab (Q2W)
-24.3
± 21.00
Placebo
-17.4
± 20.56
Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) ScoreSecondary· Baseline, Week 16
The ADIQ is a 17-item questionnaire used to assess the participant's AD-specific health-related quality of life. Each item is rated on a 5-point scale from 0 to 4, with higher numbers indicating greater burden. The questionnaire assesses AD's impact on emotions, energy, activities of daily living, and social activities. The ADIQ has a recall specification of 7 days. Assessments were recorded by the participant using an electronic diary and transferred to the clinical database.The ADIQ score is calculated by summing the score of each of the 14 questions resulting in a maximum of 56 and a minimu
Group
Value
95% CI
125 mg Lebrikizumab (Q4W)
-14.2
± 12.74
250 mg Lebrikizumab (Q4W)
-18.8
± 12.03
250 mg Lebrikizumab (Q2W)
-18.6
± 12.63
Placebo
-11.0
± 13.96
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to 271 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
125 mg Lebrikizumab (Q4W)
Serious: 2/73 (3%)
Deaths: 0/73
250 mg Lebrikizumab (Q4W)
Serious: 0/80 (0%)
Deaths: 0/80
250 mg Lebrikizumab (Q2W)
Serious: 2/75 (3%)
Deaths: 0/75
Placebo
Serious: 2/52 (4%)
Deaths: 0/52
Serious adverse events (7 terms)
Reaction
System
125 mg Lebrikizumab (Q4W)
250 mg Lebrikizumab (Q4W)
250 mg Lebrikizumab (Q2W)
Placebo
Hernial eventration
Gastrointestinal disorders
—
—
—
—
Chest pain
General disorders
—
—
—
—
Oedema peripheral
General disorders
—
—
—
—
Periprosthetic fracture
Injury, poisoning and procedural complications
—
—
—
—
Panic attack
Psychiatric disorders
—
—
—
—
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Other adverse events (190 terms — click to expand)
The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07471932 — A Study of LAD106 in Healthy Adult Participants
· Phase 1
· recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
· Phase 4
· not yet recruiting
NCT06243198 — A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants
· Phase 1
· completed
NCT05990725 — Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis
· Phase 3
· active not recruiting
NCT05372419 — A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate
· Phase 3
· completed
Other recruiting trials for Atopic Dermatitis
Currently open trials in the same condition.
NCT07262983 — Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopi
· Phase 1
· recruiting
NCT07445919 — A Clinical Study to Evaluate SM17 for Atopic Dermatitis
· Phase 2
· recruiting
NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants
· Phase 1
· recruiting
NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit
· recruiting
NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E
· Phase 1
· recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
· Phase 2
· not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
· Phase 2
· not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants
· Phase 1
· completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants
· Phase 1
· completed
NCT07030127 — A Study of LY3985863 in Healthy Participants
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 4 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03443024.