Lebrikizumab Shows Promise for Pediatric Atopic Dermatitis in Phase 3 Trial

A new biologic, lebrikizumab (Ebglyss, Eli Lilly), is showing promise as an alternative treatment option for children as young as six months with moderate-to-severe atopic dermatitis (eczema), according to topline results from a phase 3 clinical trial released March 17, 2026. The findings suggest lebrikizumab significantly improved disease severity, skin clearance, and symptom relief in young patients, offering a much-needed alternative to existing therapies like dupilumab (Dupixent; Sanofi, Regeneron).

Expanding Treatment Options for Young Children

Currently, dupilumab is the only advanced systemic medication approved for children under 12 with atopic dermatitis. “This is the first option beyond dupilumab that will be available for children as young as 6 months,” explains Amy S. Paller, MD, MS, Walter J. Hamlin professor and chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine. This is particularly important because, as Paller notes, what happens when a child doesn’t respond adequately to dupilumab, or if issues arise with its use? Until now, clinicians have largely been limited to immunosuppressors.

Atopic dermatitis is a chronic inflammatory skin condition characterized by itchy, red, and inflamed skin. It significantly impacts quality of life, particularly in children, disrupting sleep, causing discomfort, and leading to social stigma. The National Eczema Association provides comprehensive information about the condition and its management.

How Lebrikizumab Works and the ADorable-1 Trial Design

Lebrikizumab is a selective interleukin-13 (IL-13) inhibitor. IL-13 is a key cytokine – a signaling molecule in the immune system – that plays a critical role in the development and progression of atopic dermatitis. By blocking IL-13, lebrikizumab aims to reduce skin barrier dysfunction, itch, skin thickening, and the risk of infection.

The phase 3 ADorable-1 trial was a randomized, double-blind, placebo-controlled study involving 363 children with moderate-to-severe atopic dermatitis. Participants were randomly assigned to receive either a placebo or lebrikizumab, administered via weight-based injections. The initial dosing schedule involved two 250 mg injections at weeks 0 and 2, followed by 250 mg every two weeks until week 16. Throughout the study, participants were allowed to continue using topical corticosteroids, and could reduce or discontinue their use once they achieved an Investigator’s Global Assessment (IGA) score of 2 or less, indicating significant improvement.

Key Trial Results: EASI-75 and IGA Improvements

The trial assessed efficacy based on two coprimary endpoints: the proportion of participants achieving EASI-75 (a 75% improvement in the Eczema Area and Severity Index) and IGA 0 or 1 (clear or almost clear skin) at week 16. Results demonstrated a significantly higher proportion of children receiving lebrikizumab achieved these endpoints compared to those receiving placebo. Specifically, 63% of lebrikizumab-treated participants achieved EASI-75, compared to 22% in the placebo group. 44% of those on lebrikizumab reached IGA 0 or 1 with a two-point or greater reduction from baseline, versus 15% in the placebo group.

Secondary endpoints, including EASI-90 (a 90% improvement in EASI) and itch relief measured by a four-point or greater improvement on the Pruritus Numeric Rating Scale, also favored lebrikizumab. 39% of lebrikizumab recipients achieved EASI-90 compared to 11% on placebo, and 35% experienced substantial itch relief versus 6% in the placebo group.

Safety Profile and Future Considerations

The safety profile of lebrikizumab in children appeared consistent with that observed in adults and adolescents, according to Paller. No new safety signals were identified during the trial. The most commonly reported adverse events were upper respiratory tract infections and nasopharyngitis, occurring in at least 5% of participants in both the lebrikizumab and placebo groups. Conjunctivitis was also noted in a small percentage of participants.

A convenient aspect of lebrikizumab is the potential for a less frequent dosing schedule after the initial period. Following the initial dosing, children can receive lebrikizumab every four weeks, which could improve adherence and convenience for families.

Eli Lilly plans to submit the data from the ADorable-1 trial to regulatory authorities, including the FDA, with the aim of expanding the label for lebrikizumab to include younger children. The company’s press release details these plans.

What This Means for Atopic Dermatitis Management

The availability of lebrikizumab could significantly alter the treatment landscape for young children with moderate-to-severe atopic dermatitis. Having a second systemic biologic option beyond dupilumab provides clinicians with greater flexibility to tailor treatment to individual patient needs and responses. It also addresses the clinical challenge of what to do when a patient doesn’t respond to, or cannot tolerate, existing therapies.

However, it’s important to remember that biologics are not a cure for atopic dermatitis. They aim to control symptoms and improve quality of life, but ongoing management and adherence to treatment plans are crucial. The FDA’s Drug Safety Communications website provides updates on drug safety and potential risks.

Looking Ahead: The FDA previously approved lebrikizumab in September 2024 for adults and children 12 years and older with moderate-to-severe atopic dermatitis. The potential label expansion based on the ADorable-1 data would further broaden access to this treatment option. Continued monitoring of long-term safety and efficacy will be essential as more children are treated with lebrikizumab.

Contact Information: Amy S. Paller, MD, MS, can be reached at [email protected].