Phase 2
Completed N=280
A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
Source: ClinicalTrials.gov NCT03443024 ↗Enrolled (actual)
280
Serious AEs
2.1%
Results posted
May 2021
Primary outcomePrimary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) — -62.34; -69.21; -72.09; -41.12 percent change — p=0.0165
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) |
-62.34; -69.21; -72.09; -41.12 | 0.0165 sig |
| SECONDARY Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16 |
43.3; 56.1; 60.6; 24.3 | 0.0610 |
| SECONDARY 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) |
26.6; 33.7; 44.6; 15.3 | 0.1917 |
| SECONDARY Percentage of Participants With EASI <7 at Week 16 |
42.2; 61.2; 61.8; 29.3 | 0.2043 |
| SECONDARY Percentage of Participants Achieving EASI50 at Week 16 |
66.4; 77.0; 81.0; 45.8 | 0.0554 |
| SECONDARY Percentage of Participants Achieving EASI90 at Week 16 |
26.1; 36.1; 44.0; 11.4 | 0.0800 |
| SECONDARY Percent Change From Baseline in the Sleep Loss Scale Score |
-48.68; -53.03; -64.69; -20.24 | 0.0773 |
| SECONDARY Percent Change From Baseline in Pruritus Numeric Rating Score (NRS) |
-35.94; -49.60; -60.63; 4.26 | 0.0047 sig |
| SECONDARY Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16 |
50.9; 64.9; 76.0; 45.5 | 0.6674 |
| SECONDARY Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16 |
41.8; 47.4; 70.0; 27.3 | 0.2371 |
| SECONDARY Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD) |
-19.6; -24.9; -24.3; -17.4 | 0.4631 |
| SECONDARY Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) Score |
-14.2; -18.8; -18.6; -11.0 | 0.4729 |
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 years or older.
- Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit .
- Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit.
- Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit.
- ≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit.
Exclusion Criteria
- 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 topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week prior to the baseline visit.
- Treatment with:
- An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit.
- Dupilumab within 3 months prior to baseline visit.
- Cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit.
- Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit (whichever is longer).
- Use of prescription moisturizers within 7 days of the baseline visit.
Data sourced from ClinicalTrials.gov (NCT03443024). 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.