Can Nemolizumab Help Children Under 12 with Moderate-to-Severe Eczema?

Children aged 2 - 11 years with moderate-to-severe atopic dermatitis experienced early and lasting improvements in itch, sleep, and quality of life with nemolizumab, according to new phase 2 data Galderma announced in October 2026.¹ The patient-reported outcomes, sustained through week 52, are being presented at the 2026 Pediatric Dermatology Research Alliance (PeDRA) Annual Conference.

Nemolizumab, marketed as Nemluvio in the US, is a monoclonal antibody that blocks signaling of interleukin (IL)-31, a neuroimmune cytokine implicated in itch, inflammation, epidermal dysregulation, and fibrosis. The US Food and Drug Administration (FDA) has approved the agent for adults with prurigo nodularis and for patients aged 12 years and older with moderate-to-severe atopic dermatitis, when used alongside topical corticosteroids and/or calcineurin inhibitors in disease not adequately controlled by topical prescription therapies. Its safety and efficacy have not yet been established in children younger than 12 years with atopic dermatitis.

How Was Nemolizumab Studied in Children Aged 2 - 11 Years?

The multicenter, open-label phase 2 trial assessed the pharmacokinetics, safety, and efficacy of nemolizumab use in pediatric patients with moderate-to-severe disease, along with patient-reported outcomes and quality-of-life measures. Investigators sorted participants into 3 cohorts by age and weight. Each child received weight-tiered nemolizumab dosing combined with topical therapy.

Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego School of Medicine and chief of pediatric dermatology at Rady Children’s Hospital-San Diego, is the lead author of the abstract.

What Did the Phase 2 Results Show for Itch, Quality of Life, and Sleep?

Itch relief emerged early in treatment and persisted across the full year of follow-up. At week 16, between 56% and 72% of children across the 3 cohorts achieved at least a 4-point improvement on the Peak Pruritus Numerical Rating Scale, and response rates at week 52 were comparable or higher.

Sleep followed a similar trajectory. Scores on the Sleep Disturbance Numerical Rating Scale fell by 70% to 78% across cohorts at week 16, with additional gains recorded by week 52.

Quality-of-life outcomes also improved. Among children aged 4 years and older, mean Children’s Dermatology Life Quality Index scores declined from baseline by 10.7, 12.0, and 12.0 points across the cohorts at week 52. Improvements also appeared on age-specific instruments, including the Infants’ Dermatitis Quality of Life index for children younger than 4 years and the Patient-Oriented Eczema Measure for those aged 4 years and older.

Galderma reported nemolizumab was well tolerated in this younger population, with no new safety signals identified. The company noted the findings align with the established safety and efficacy profile of the agent in adolescents and adults with moderate-to-severe atopic dermatitis.

Why Do These Data Matter for Pediatric Atopic Dermatitis Care?

Atopic dermatitis affects up to 25% of children and is the most common inflammatory skin disease in this age group, with roughly one-third of affected children having moderate-to-severe disease. Persistent itch and recurrent lesions frequently interfere with sleep, school performance, and social confidence, and the burden extends to caregivers and families. Even so, approved systemic options for younger children with moderate-to-severe disease remain limited.

Eichenfield emphasized the considerable toll atopic dermatitis takes on children’s emotional well-being and daily functioning, and he pointed to an ongoing need for therapies capable of delivering meaningful benefit in this group. He described the sustained gains in itch, sleep, and quality of life over a single year as encouraging.

Christophe Piketty, MD, PhD, a study author and global program head for therapeutic dermatology at Galderma, described the results as adding to the existing clinical evidence for nemolizumab and supporting its potential implementation in a broader population, including young children.

Editor's Note: This summary has been edited for grammar and clarity using artificial intelligence tools.

References

1. Galderma. PeDRA 2026: Nemolizumab phase II data show long-term symptom relief for children aged 2 to 11 years with moderate-to-severe atopic dermatitis. Published October 15, 2026. Accessed October 17, 2026. https://www.galderma.com/news/pedra-2026-nemolizumab-phase-ii-data.

2. Eichenfield LF, et al. Patient-reported outcomes and quality of life in pediatric patients (aged 2–11 years) with moderate-to-severe atopic dermatitis treated with nemolizumab. Presented at: Pediatric Dermatology Research Alliance (PeDRA) Annual Conference; October 15-17, 2026; United States.