ZUG, Switzerland, October 15, 2026
Galderma (SIX: GALD) announced Phase II clinical data showing sustained improvements in itching, sleep disturbance and quality of life among children aged 2 to 11 years with moderate-to-severe atopic dermatitis treated with nemolizumab. The findings, which will be presented at the Pediatric Dermatology Research Alliance (PeDRA) Annual Conference, demonstrate that patient-reported improvements were maintained through Week 52. The multicenter, open-label study evaluated the investigational treatment’s pharmacokinetics, safety and efficacy, alongside patient-reported outcomes and quality-of-life measures. Children were assigned to three cohorts according to age and weight and received weight-based nemolizumab dosing in combination with topical therapy. The results are relevant to a pediatric population with limited approved treatment options for moderate-to-severe disease. Galderma reported early improvements in itch severity and sleep disturbance, with further gains in selected quality-of-life measures during follow-up. The treatment was generally well tolerated in the study, with no new safety signals reported. However, nemolizumab’s use for atopic dermatitis in children younger than 12 years remains investigational, and the Phase II findings do not establish regulatory approval for this age group.
Phase II Findings Show Sustained Symptom Improvements
The Phase II study assessed nemolizumab in children aged 2–11 years with moderate-to-severe atopic dermatitis, a chronic inflammatory skin condition associated with persistent itching and recurring skin lesions. Patient-reported outcomes showed improvements in itch severity, sleep disturbance and quality of life that were sustained over one year. At Week 16, Peak Pruritus Numerical Rating Scale four-point response rates ranged from 56% to 72% across the three study cohorts, with similar or higher responses reported at Week 52. Sleep disturbance also improved early and remained improved through the end of follow-up. Measured using the Sleep Disturbance Numerical Rating Scale, scores improved by 70% to 78% at Week 16 across cohorts, with further improvements at Week 52. Quality-of-life outcomes also showed gains. At Week 52, mean Children’s Dermatology Life Quality Index scores improved from baseline by 10.7, 12.0 and 12.0 points across the respective cohorts. Improvements were also reported on age-appropriate measures, including the Infants’ Dermatitis Quality of Life index for children younger than four years and the Patient-Oriented Eczema Measure for children aged four years and older. These measures capture different aspects of the disease’s impact on children’s daily lives. The study’s open-label design and the absence of a control group should be considered when interpreting the findings.
Addressing the Burden of Pediatric Atopic Dermatitis
Atopic dermatitis is the most common inflammatory skin disorder in children and can affect sleep, school participation, social confidence and family routines. Galderma cited estimates that the condition affects up to 25% of children, with approximately one-third experiencing moderate-to-severe disease. Persistent itching and recurrent skin lesions can impose a substantial burden on both children and their caregivers, while treatment options for younger children with more severe disease remain limited. Lawrence Eichenfield, M.D., 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, described the sustained improvements in itch, sleep disturbance and quality of life as promising. Galderma study author Christophe Piketty, M.D., Ph.D., Global Program Head of Therapeutic Dermatology, said the findings add to the clinical evidence supporting further evaluation of nemolizumab in broader patient populations. The results are patient-reported and reflect changes during treatment over the 52-week study period. Additional evidence will be needed to establish the treatment’s benefit-risk profile in children aged 2–11 and to determine whether the findings support future regulatory submissions for this age group.
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Nemolizumab’s Mechanism and Regulatory Status
Nemolizumab is a monoclonal antibody that targets the interleukin-31 receptor alpha (IL-31RA), blocking signaling by IL-31, a neuroimmune cytokine involved in itch and processes associated with inflammation and skin changes. The medicine was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive worldwide development and marketing rights, excluding Japan, where the product is marketed as Mitchga®. In the United States, nemolizumab is marketed as Nemluvio® and is approved for adults with prurigo nodularis and for adults and pediatric patients aged 12 years and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when prescription topical therapies do not adequately control the disease. Galderma reports that nemolizumab has approvals for these indications in more than 40 countries. The treatment is not approved for atopic dermatitis in children younger than 12 years, and its use in this population remains investigational. The Phase II findings presented at PeDRA add longer-term pediatric symptom and quality-of-life data to the program’s evidence base. Further clinical and regulatory evaluation will determine whether nemolizumab may eventually offer another treatment option for younger children with moderate-to-severe atopic dermatitis.
Source::Galderma, press release
