Phase 3
Completed N=424
Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate1)
Atopic Dermatitis
Source: ClinicalTrials.gov NCT04146363 ↗
Enrolled (actual)
424
Serious AEs
1.8%
Results posted
Aug 2022
Primary outcomePrimary: Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 — 12.7; 43.1 percentage of participants — p=<0.000001
◆ Published Evidence
Emerging
11citations · ~6 / year
Patients with Moderate-to-Severe Atopic Dermatitis Maintain Stable Response with No or Minimal Fluctuations with 1 Year of Lebrikizumab Treatment.
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.
Linked Publications (5)
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Patients with Moderate-to-Severe Atopic Dermatitis Maintain Stable Response with No or Minimal Fluctuations with 1 Year of Lebrikizumab Treatment.
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Improvement Across Dimensions of Disease with Lebrikizumab Use in Atopic Dermatitis: Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Monotherapy Trials (ADvocate1 and ADvocate2).
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Lebrikizumab Rapidly Lowers Inflammatory Biomarkers with Clinical Correlations in Moderate-to-Severe Atopic Dermatitis.
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Lebrikizumab is efficacious in adults and adolescents with moderate-to-severe atopic dermatitis regardless of atopic comorbidities.
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Lebrikizumab provides stable skin response with no or minimal fluctuations for up to 2 years in patients with atopic dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 |
12.7; 43.1 | <0.000001 sig |
| PRIMARY Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16 |
16.2; 58.8 | <0.000001 sig |
| SECONDARY Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2 |
0.7; 2.5 | 0.218644 |
| SECONDARY Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4 |
0.8; 10.6 | 0.000498 sig |
| SECONDARY Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 in Adults |
11.3; 42.2 | <0.000001 sig |
| SECONDARY Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16 |
9.0; 38.3 | <0.000001 sig |
| SECONDARY Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 |
-15.06; -45.48 | <0.000001 sig |
| SECONDARY Percentage of Participants With a Pruritus NRS Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16 |
13.0; 45.9 | <0.000001 sig |
| SECONDARY Percentage of Participants With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16 |
13.7; 49.0 | <0.000001 sig |
| SECONDARY Percent Change in EASI Score From Baseline to Week 16 |
-26.01; -64.31 | <0.000001 sig |
| SECONDARY Change From Baseline in Percent Body Surface Area (BSA) at Week 16 |
-11.7; -30.2 | <0.000001 sig |
| SECONDARY Percentage of Participants Achieving EASI-90 From Baseline to Week 4 |
1.6; 12.4 | 0.000412 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 |
-2.9; -8.7 | <0.000001 sig |
| SECONDARY Percentage of Participants Achieving ≥4 Point Improvement in DLQI From Baseline to Week 16 |
32.4; 71.5 | <0.000001 sig |
| SECONDARY Percentage of Participants With a DLQI Total Score of ≥4-point at Baseline Achieving ≥4-point Improvement in DLQI From Baseline to Week 16 |
33.8; 75.6 | <0.000001 sig |
| SECONDARY Percent Change in Sleep-loss Score From Baseline to Week 16 |
-15.99; -48.33 | <0.000001 sig |
| SECONDARY Change From Baseline in Sleep-loss Score at Week 16 |
-0.38; -1.13 | <0.000001 sig |
| SECONDARY Percentage of Participants With a Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline at Week 16 |
4.7; 39.0 | <0.000001 sig |
| SECONDARY Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1 |
0.8; 2.3 | 0.275529 |
| SECONDARY Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2 |
0.9; 6.1 | 0.016656 sig |
| SECONDARY Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4 |
2.3; 21.5 | 0.000003 sig |
| SECONDARY Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1 |
0.8; 2.5 | 0.244105 |
| SECONDARY Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2 |
0.9; 6.6 | 0.014450 sig |
| SECONDARY Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4 |
2.4; 23.1 | 0.000002 sig |
| SECONDARY Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16 |
-16.64; -46.93 | <0.000001 sig |
| SECONDARY Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab at Week 52 |
40.7; 75.7 | — |
| SECONDARY Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continued to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score) |
61.3; 79.2; 79.2 | 0.072375 |
| SECONDARY Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 16 Who Continue to Exhibit and IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 52 |
46.5; 74.2; 75.8 | 0.029857 sig |
| SECONDARY Percentage of Participants From Those With a Pruritus NRS of ≥4-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52 |
65.4; 80.4; 81.2 | 0.268265 |
| SECONDARY Percentage of Participants From Those With a Pruritus NRS of ≥5-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52 |
65.4; 83.3; 81.2 | 0.185361 |
| SECONDARY Percent Change in SCORAD (Having Achieved EASI-75 at Week 16) From Baseline at Week 52 |
-69.65; -71.39; -75.28 | 0.714208 |
| SECONDARY Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index |
0.0; 0.2; 0.0; 0.1 | <0.000001 sig |
| SECONDARY Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS) |
2.1; 10.4 | <0.000001 sig |
| SECONDARY Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 |
-3.9; -11.3 | <0.000001 sig |
| SECONDARY Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adolescents |
-2.80; -3.87 | 0.716224 |
| SECONDARY Change From Baseline in PROMIS Depression at Week 16 - Adolescents |
-0.11; -4.62 | 0.089275 |
| SECONDARY Change From Baseline in PROMIS Anxiety at Week 16 - Adults |
-0.60; -3.91 | 0.000040 sig |
| SECONDARY Change From Baseline in PROMIS Depression at Week 16 - Adults |
-0.37; -3.07 | 0.000127 sig |
| SECONDARY Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-Reported Comorbid Asthma |
-0.05; -0.14 | 0.455291 |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 - Adolescents |
-1.0; -8.0 | 0.000069 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female adults and adolescents (≥12 years and ≥40 kg)
- Chronic atopic dermatitis (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 atopic dermatitis involvement at the baseline visit
- History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable
Exclusion Criteria
- Prior treatment with dupilumab or tralokinumab
- Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
- Treatment with any of the following agents within 4 weeks prior to the baseline visit:
- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy and photochemotherapy (PUVA) for AD
- Treatment with the following prior to the baseline visit:
- An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer
- Cell-depleting biologics, including to rituximab, within 6 months of baseline
- Other biologics within 5 half-lives (if known) or 16 weeks of baseline, 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, e.g., co-morbid severe uncontrolled asthma
- Evidence of active acute or chronic hepatitis
- History of human immunodeficiency virus (HIV) infection or positive HIV serology
- 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 (NCT04146363) 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.