What Phase 2 Nemolizumab Data Show in Children 2-11 With Atopic Dermatitis

Nemolizumab (Nemluvio) produced durable improvements in itch, sleep disturbance and quality of life among children aged 2 - 11 years with moderate-to-severe atopic dermatitis in a phase 2 open-label study, according to data Galderma presented at the 2026 Pediatric Dermatology Research Alliance (PeDRA) Annual Conference.¹

Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego, professor of dermatology and pediatrics and vice chair of the Department of Dermatology at UC San Diego School of Medicine, and director of the Rady Children’s/UC San Diego Eczema and Inflammatory Skin Disease Center, discussed the findings with HCPLive.

Children in 3 age- and weight-based cohorts received weight-tiered nemolizumab, an interleukin (IL)-31 receptor alpha antibody, with topical therapy through week 52.¹ At week 16, 56% to 72% of children across cohorts achieved at least a 4-point improvement on the Peak Pruritus Numerical Rating Scale, with similar or higher rates at week 52.¹ Nemolizumab is currently approved for patients aged 12 years and older with moderate-to-severe atopic dermatitis.²

Because the youngest children can’t reliably rate their own itch, Eichenfield noted, the study relied on caregiver-reported surrogate measures. Sleep disturbance scores fell by 70% to 78% across cohorts at week 16 and improved further through week 52.¹ Eichenfield described sleep as a core treatment goal.

“We try to get to the point of minimal rash, minimal itch, and minimal sleep disturbance,” Eichenfield expressed. “The sleep disturbance obviously is highly impacted by itch and the state of the cutaneous eczema. But it is also something I think has compounding effects, because if kids are up, often other family members are up.”

Among children aged 4 years and older, mean Children’s Dermatology Life Quality Index scores improved by 10.7 to 12.0 points from baseline at week 52. Galderma also reported gains on the Infants’ Dermatitis Quality of Life Index and the Patient-Oriented Eczema Measure.¹ The company reported no new safety signals.¹ Eichenfield said he uses these indices mainly in clinical studies rather than routine practice, as composite measures of a drug’s effect across the domains of disease burden.

He named the open-label design, the lack of a comparator group and the relatively small cohorts as limitations. Still, he described the data as a step toward potential use in patients younger than 12 years, citing pharmacokinetic results and a safety profile consistent with the adolescent and adult trials.

Disclosures: This summary was edited for grammar and clarity using AI tools. Eichenfield previously reported receiving personal fees from Pfizer Inc; grant funding from AbbVie, Arcutis Biotherapeutics, Bausch + Lomb, Castle Biosciences, Dermavant Sciences Inc, Galderma SA, Pfizer Inc, Regeneron, and Sanofi SA and consulting for ASLAN Pharmaceuticals, AbbVie, Almirall, SA, Arcutis Biotherapeutics, Arena Pharmaceuticals Inc, Dermavant Sciences Inc, Galderma SA, Incyte Corporation, LEO Pharma A/S, Eli Lilly and Company, Ortho Dermatologics, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi SA, and UCB; and serving on the board of directors of Forté Pharma.

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 30, 2026. https://www.galderma.com/news/pedra-2026-nemolizumab-phase-ii-data.

2. Smith T. Can nemolizumab help children under 12 with moderate-to-severe eczema? HCPLive. Published October 18, 2026. Accessed October 30, 2026. https://www.hcplive.com/view/can-nemolizumab-help-children-under-12-moderate-severe-eczema-.