Phase 3
Completed N=228
Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.
Atopic Dermatitis
Source: ClinicalTrials.gov NCT04250337 ↗
Enrolled (actual)
228
Serious AEs
1.3%
Results posted
May 2022
Primary outcomePrimary: Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16. — 22.1; 41.2 percentage of participants — p=0.011
◆ Published Evidence
Highly cited
136citations · ~45 / year
Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere).
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
Linked Publications
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Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16. |
22.1; 41.2 | 0.011 sig |
| PRIMARY Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16 |
42.2; 69.5 | <.001 sig |
| SECONDARY Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16 |
21.7; 41.2 | 0.008 sig |
| SECONDARY Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 |
-35.47; -50.68 | 0.017263 sig |
| SECONDARY Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16 |
31.9; 50.6 | 0.017 sig |
| SECONDARY Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16 |
26.4; 46.8 | 0.007 sig |
| SECONDARY Percent Change in EASI Score From Baseline at Week 16 |
-53.12; -76.76 | 0.000003 sig |
| SECONDARY Change From Baseline to Week 16 in Percent Body Surface Area (BSA) |
16.92; -29.19 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving EASI-90 at Week 4 |
7.2; 10.7 | 0.454 |
| SECONDARY Percent Change in Sleep-loss Score From Baseline to Week 16 |
-36.89; -57.03 | 0.117607 |
| SECONDARY Change From Baseline in Sleep-loss Score at Week 16 |
-0.80; -1.10 | 0.025293 sig |
| SECONDARY Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4 |
9.3; 23.5 | 0.022 sig |
| SECONDARY Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2 |
7.1; 8.5 | 0.764 |
| SECONDARY Percentage of Participants With a Pruritus NRS of ≥4-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1 |
1.8; 3.8 | 0.498 |
| SECONDARY Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4 |
7.5; 23.4 | 0.014 sig |
| SECONDARY Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2 |
7.5; 8.9 | 0.818 |
| SECONDARY Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1 |
1.9; 4.0 | 0.499 |
| SECONDARY Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16 |
23.88; 31.17 | 0.155 |
| SECONDARY Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16 |
NA; 121.0 | — |
| SECONDARY Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16 |
-37.35; -55.04 | <0.001 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 |
-6.46; -9.79 | 0.001031 sig |
| SECONDARY Percentage of Participants With a DLQI Score ≥4 Points at Baseline Who Achieve a ≥4 Points |
58.7; 77.4 | 0.036 sig |
| SECONDARY Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index |
0.05; 0.15; 0.03; 0.10 | <0.001 sig |
| SECONDARY Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS) |
6.51; 10.13 | 0.131 |
| SECONDARY Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 |
-6.24; -10.23 | <0.001 sig |
| SECONDARY Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults |
-1.08; -1.88 | 0.571 |
| SECONDARY Change From Baseline in PROMIS Depression at Week 16 - Adults |
-1.21; -1.38 | 0.882 |
| SECONDARY Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics |
-4.92; -1.46 | 0.171 |
| SECONDARY Change From Baseline in PROMIS Depression at Week 16 - Pediatrics |
-6.43; -2.01 | 0.109 |
| SECONDARY Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma |
0.12; 0.13 | 0.922 |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 |
-4.71; -9.33 | 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female adult and adolescents (≥12 years to <18 years, and weighing ≥40 kg).
- Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
- Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
- Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
- ≥10% body surface area (BSA) of AD involvement at the baseline visit.
- History of inadequate response to treatment with topical medications.
Exclusion Criteria
- Participation in a prior lebrikizumab clinical study.
- Treatment with the following prior to the baseline visit:
- An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
- Dupilumab within 8 weeks.
- B-cell-depleting biologics, including to rituximab, within 6 months.
- Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
- Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
- Uncontrolled chronic disease that might require bursts of oral corticosteroids.
- Evidence of active acute or chronic hepatitis
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- 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 non-metastatic squamous or basal cell carcinoma of the skin.
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
Data sourced from ClinicalTrials.gov (NCT04250337) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.