Lilly’s EBGLYSS Meets Phase 3b Goals in Hand-and-Foot Atopic Dermatitis Study

Eli Lilly said its EBGLYSS treatment met the primary and secondary endpoints in a Phase 3b study focused on adults and adolescents with moderate-to-severe atopic dermatitis affecting the hands and feet. At Week 16, 53% of patients receiving EBGLYSS had clear or almost clear skin on both areas with at least a two-point improvement on the study’s investigator scale, compared with 27% of patients receiving placebo.

The result came from ADtouch, a 221-patient randomized trial designed around a difficult-to-treat form of atopic dermatitis that can be highly disruptive even when the total amount of affected skin is limited. Most patients entered the study with severe hand-and-foot itch, moderate pain and substantial quality-of-life impairment, while having relatively limited disease elsewhere on the body.

In its Sept. 30 Phase 3b announcement, Lilly said the Week 16 primary endpoint was statistically significant under the trial’s multiplicity-control plan. The company also reported significant improvements on several prespecified secondary measures, including itch, pain and patient satisfaction with hand clearance.

Clearance, itch and pain all favored EBGLYSS

The separation between treatment and placebo was visible before Week 16. By Week 4, 17% of patients on EBGLYSS had reached the study’s clear-or-almost-clear hand-and-foot threshold with the required improvement from baseline, versus 6% on placebo. The larger Week 16 gap, 53% versus 27%, formed the study’s primary efficacy result.

Patient-reported symptoms also moved in favor of EBGLYSS. Among participants with sufficient baseline itch to be evaluated on the study’s peak-pruritus measure, 57% of the treatment group achieved at least a four-point improvement by Week 16, compared with 19% on placebo. Lilly reported a significant itch difference as early as Week 2, when 16% of EBGLYSS patients had reached that threshold versus 1% of placebo patients.

Pain showed a similar pattern at the main 16-week readout. Lilly said 59% of eligible EBGLYSS patients achieved at least a four-point improvement on the hand-and-foot peak-pain scale, compared with 19% on placebo. On a separate satisfaction measure for patients who were dissatisfied with their hand clearance at baseline, 77% of EBGLYSS recipients reported being satisfied or very satisfied at Week 16, versus 40% in the placebo group. Rescue medication was used by 6% of patients receiving EBGLYSS and 18% receiving placebo through Week 16.

ADtouch tested a localized, difficult-to-treat population

ADtouch was a double-blind, placebo-controlled Phase 3b trial in patients with a history of moderate-to-severe atopic dermatitis and at least one year of hand-and-foot involvement. Eligible participants needed involvement in at least two of four hand-and-foot anatomical areas, a moderate or severe investigator score, a minimum itch score, and an inadequate response to topical therapies. Adults and adolescents ages 12 to 17 could participate, with adolescents required to weigh at least 40 kilograms.

The 221 participants were randomized 1:1 to EBGLYSS 250 mg or placebo every two weeks after an initial loading dose. All participants used moisturizer on their hands and feet. That design matters when reading the results: the study evaluated EBGLYSS as the active systemic treatment during a 16-week controlled period, rather than comparing it with another biologic or a different active systemic drug.

Lilly said treatment-emergent adverse events occurred in 41.8% of patients receiving EBGLYSS and 39.6% of those on placebo, and that all reported events were mild or moderate in severity. The most common adverse reactions occurring in at least 5% of EBGLYSS patients were nasopharyngitis and upper respiratory tract infection. Adverse events led to treatment discontinuation in 0.9% of the EBGLYSS group and 2.7% of the placebo group. The announced analysis covers the 16-week controlled phase, so it does not by itself establish how the hand-and-foot-specific outcomes develop over a longer treatment period.

FDA submission could add hand-and-foot data to the label

EBGLYSS, or lebrikizumab-lbkz, is an interleukin-13 antagonist. The current U.S. prescribing information covers adults and pediatric patients age 12 and older who weigh at least 40 kilograms and have moderate-to-severe atopic dermatitis that is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. The label allows treatment with or without topical corticosteroids.

The FDA updated the dosing section in June 2026 to include an every-eight-week maintenance option, alongside the every-four-week maintenance schedule, after the initial every-two-week dosing period. Lilly is now seeking a different kind of label addition from ADtouch. The company said it has submitted the new hand-and-foot data to the FDA and plans submissions to selected regulators outside the United States for a potential label update covering localized atopic dermatitis with moderate-to-severe hand-and-foot involvement. A submission does not mean the FDA has accepted the requested labeling, and Lilly did not give a timetable for an agency decision.

The study also arrives as EBGLYSS is becoming a larger commercial product for Lilly. The company reported $201 million of EBGLYSS revenue in the second quarter of 2026, up 131% from $87 million a year earlier. First-half revenue reached $346 million, compared with $147 million in the first half of 2025. Lilly classifies EBGLYSS among its key products and has continued to expand the drug’s dosing flexibility and clinical dataset since its U.S. approval in 2024.

Lilly said the ADtouch results are being presented as late-breaking data at the European Academy of Dermatology and Venereology Congress in Vienna. For the U.S. market, the next concrete step is the FDA’s review of the submitted dataset and any resulting decision on whether the hand-and-foot findings are added to EBGLYSS labeling.