Lilly posts Phase 3 results for lebrikizumab in atopic dermatitis
Eli Lilly’s completed Phase 3 study enrolled 301 participants with moderate-to-severe atopic dermatitis. The registry reports Week 16 EASI-75 response rates across the treatment groups, with results first posted on 2026-10-16.
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Eli Lilly and Company posted results on ClinicalTrials.gov for a completed Phase 3 study of lebrikizumab in participants with moderate-to-severe atopic dermatitis. The record for NCT06280716 says results were first posted on 2026-10-16. The study compared lebrikizumab with placebo, both with and without topical corticosteroid treatment.
Trial design and results
The registry lists 301 participants and describes the study as randomized, double-blind, parallel-group and placebo-controlled. Its brief summary says the study lasted approximately 62 weeks. The primary outcomes were measured at Week 16, while the study record lists overall status as Completed.
Participants had to have chronic AD present for ≥1 year, or chronic eczema meeting the listed criteria, and moderate-to-severe disease. At baseline, the record required an EASI score of ≥16, an IGA score of ≥3 on a scale from 0 to 4, and ≥10% BSA of AD involvement. It also required a documented inadequate response to existing topical medications within 6 months preceding screening. Adolescents had to weigh ≥40 kg at baseline.
The study assigned participants to a combination cohort or a monotherapy cohort. In the combination cohort, participants received placebo plus topical corticosteroid or 250 mg lebrikizumab plus topical corticosteroid through Week 16. In the monotherapy cohort, participants received placebo or 250 mg lebrikizumab through Week 16. The registry describes injections as subcutaneous and administered every 2 weeks.
One primary outcome was the percentage of participants achieving EASI-75 at Week 16. In the Combo Cohort: Placebo + TCS group (n = 56), the registry reports 37.8%; in the Combo Cohort: 250 mg Lebrikizumab + TCS group (n = 112), it reports 57.5%. In the Mono Cohort: Placebo group (n = 44), the reported value was 18.5%; in the Mono Cohort: 250 mg Lebrikizumab group (n = 89), it was 51.7%. These are the percentages posted in the registry for the treatment groups.
The registry also reports an analysis comparing the combination groups. It lists a posterior mean response difference of 22.0 and a 90% credible interval from 9.3 to 33.2. For the monotherapy comparison, it lists a risk difference of 32.1 and a 95% interval from 17.6 to 46.5. The record describes the combination analysis as Bayesian and says it reports posterior mean response differences and credible intervals instead of confidence intervals. These are registry entries, not a separate interpretation of the results.
The second primary outcome measured the percentage of participants with an IGA score of 0 or 1 and a reduction of ≥2 points from baseline to Week 16. The registry explains that IGA is an investigator’s overall severity assessment, using a 5-point numeric scale from 0, clear skin, to 4, severe disease. The posted responses were higher in the lebrikizumab groups than in their placebo comparison groups in both cohorts.
The record includes safety results for participants who received at least 1 dose of study intervention, with a time frame from baseline through Week 16. It lists deaths, serious adverse events and other adverse events by treatment group. The registry does not state that a reported event was caused by the study treatment, so the entries should be read as reported events rather than causal conclusions.
ClinicalTrials.gov identifies Eli Lilly and Company as the study sponsor. The record lists the study as completed and results as posted, but does not provide a next research step. The posted data cover the trial’s listed groups and outcomes; they do not establish how the findings compare with other treatments or what participants experienced beyond the recorded measures.