Late-Breaking Data Highlight Nemolizumab Efficacy in Children with Atopic Dermatitis

New phase 2 findings presented in a late-breaking session at the 2026 American Academy of Dermatology (AAD) Annual Meeting suggest nemolizumab may provide children as young as 2 years old with moderate-to-severe atopic dermatitis with an effective and well-tolerated treatment option.1,2

Atopic dermatitis is a skin disease which is known to be the most prevalent inflammatory condition in the pediatric patient population. In its moderate-to-severe form, the disease can substantially impact the quality of life of children and adults, given the associated chronic pruritus and recurring skin lesions disrupting sleep and other activities.

“In our study, nemolizumab demonstrated a clinically meaningful benefit in children with moderate-to-severe atopic dermatitis, helping to reduce skin lesions and itch up to one year, and had a similar safety profile as with adults and adolescents,” Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology and pediatrics at the UC San Diego School of Medicine, said in a statement.1

In this phase 2 study (NCT04921345), sponsored by Galderma, Eichenfield and colleagues assessed nemolizumab’s pharmacokinetics, safety, and efficacy. They looked at weight-based dosing in children aged 2 - 11 years, with weight-tiered doses of 5 mg, 10 mg, and 15 mg leading to pharmacokinetic profiles described as comparable to those observed in adults and adolescents.

Among 2 of the study’s age cohorts, children aged 2 - 6 and 7 - 11, efficacy signals emerged early and persisted through the 52-week mark. On the Investigator's Global Assessment, Eichenfield et al found 41% - 47% of patients achieved clear or almost clear skin by the 16-week mark, with improvements being first detectable as early as Week 4. Similarly, the team found 69% - 73% of children attained a 75% improvement on the Eczema Area and Severity Index (EASI) by the 16-week mark, again with responses apparent from Week 4 onward.

Reduction in itch was also shown to be rapid. Using a clinically meaningful threshold on the Peak Pruritus Numerical Rating Scale, meaningful relief from pruritus was documented as early as the first week. By the 16-week mark, investigators observed achievement of 72% of the younger cohort and 59% of the older cohort of this threshold. Response rates at Week 52 were described as comparable to or exceeding those seen at Week 16 across all endpoints, suggesting durable benefit over a full year of nemolizumab use.

The safety profile was found to be consistent with what has been established in adult and adolescent patients. Additionally, there were no new concerns identified in the pediatric setting.

Nemolizumab is currently approved in the US and EU for those living with moderate-to-severe atopic dermatitis in adults and adolescents. It is also approved for prurigo nodularis in adults. A pediatric approval has not yet been established.

References

1. AAD 2026: Late-breaking nemolizumab data demonstrate clinically meaningful benefits for children aged 2 to 11 with moderate-to-severe atopic dermatitis. Galderma. March 28, 2026. https://www.galderma.com/news/aad-2026-late-breaking-data-atopic-dermatitis.

2. Eichenfield LF, et al. Pharmacokinetics, safety, and efficacy of nemolizumab in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis. Late breaking abstract presented at 2026 American Academy of Dermatology (AAD) Annual Meeting; March 27-31, 2026; United States.