Galderma reports sustained improvements in itch, sleep and quality of life with nemolizumab in children aged 2–11 years through Week 52.
Written By: Aasritha Thippavajjala, PharmD
Reviewed By: Pharmacally Editorial Team
Galderma reported improvements in itch, sleep disturbance and quality of life through Week 52 in children aged 2–11 years with moderate-to-severe atopic dermatitis, based on patient-reported outcomes from a Phase II study (NCT04921345). Announced on October 15, 2026, the findings will be presented at the Pediatric Dermatology Research Alliance (PeDRA) Annual Conference. The results extend the investigation of nemolizumab to younger children, a population with limited approved treatment options for moderate-to-severe disease.
Study Design and Patient Population
The multicenter, open-label, non-randomized study evaluated the pharmacokinetics, safety and efficacy of nemolizumab in children aged 2–11 years. The trial enrolled 109 participants across 23 sites in the United States and Europe and was completed on April 28, 2025.
Eligible children had moderate-to-severe atopic dermatitis, with disease severity assessed using the Eczema Area and Severity Index (EASI), Investigator’s Global Assessment (IGA), body surface area involvement and peak itch scores. Participants received subcutaneous nemolizumab every four weeks for 52 weeks following a loading dose, with dosing determined by body weight. Background treatment included moisturizers and topical corticosteroids, as appropriate.
The study’s primary objectives included pharmacokinetic assessment and safety and tolerability. Clinical efficacy measures and patient-reported outcomes, including itch, sleep disturbance and quality of life, were assessed as secondary outcomes.
Improvements in Itch and Sleep Disturbance
At Week 16, Galderma reported that 56%–72% of participants across the study cohorts achieved an improvement of at least four points from baseline on the Peak Pruritus Numerical Rating Scale. Similar or higher response rates were reported at Week 52, although the announcement did not provide cohort-specific numerical results for that time point.
Sleep disturbance also improved during treatment. Sleep Disturbance Numerical Rating Scale scores decreased by 70%–78% from baseline at Week 16 across cohorts, according to Galderma. The company reported further improvements through Week 52 but did not disclose the corresponding numerical values.
These findings indicate changes in two patient-reported outcomes that are particularly relevant to children with atopic dermatitis. Persistent itch can disrupt sleep and daily functioning, making symptom control an important treatment objective. However, the reported changes cannot establish how much improvement was attributable to nemolizumab rather than background treatment, other factors or the natural course of disease.
Quality-of-Life Outcomes and Safety
Among children aged four years and older, mean Children’s Dermatology Life Quality Index (cDLQI) scores improved by 10.7, 12.0 and 12.0 points from baseline at Week 52 across the reported cohorts. The cDLQI ranges from 0 to 30, with higher scores indicating greater impairment. Galderma also reported improvements on the age-appropriate Infants’ Dermatitis Quality of Life Index and the Patient-Oriented Eczema Measure, without providing numerical results for these measures.
Galderma described nemolizumab as well tolerated, with no new safety signals. However, the announcement did not provide adverse-event counts, severity breakdowns or treatment-discontinuation data. The available information therefore does not permit an independent assessment of the safety findings in this pediatric population.
Regulatory Context and Clinical Interpretation
In the United States, Nemluvio (nemolizumab-ilto) is approved for moderate-to-severe atopic dermatitis in adults and patients aged 12 years and older whose disease is not adequately controlled with prescription topical therapies, in combination with topical corticosteroids and/or calcineurin inhibitors. Its safety and effectiveness for atopic dermatitis have not been established in children younger than 12 years.
The Phase II findings extend the clinical investigation of nemolizumab to younger children but do not establish a new approved indication.
Overall, the reported improvements in itch, sleep disturbance and quality of life through Week 52 support further evaluation of nemolizumab in children aged 2–11 years with moderate-to-severe atopic dermatitis. Nevertheless, the absence of a control group, limited numerical reporting and lack of detailed safety data restrict conclusions about the magnitude of treatment benefit and its attribution to nemolizumab. The findings do not establish superiority over existing treatments or demonstrate that improvements persist beyond the 52-week study period.
Reference
PeDRA 2026: Nemolizumab phase II data show long-term symptom relief for children aged 2 to 11 years with moderate-to-severe atopic dermatitis, Galderma, 15 October 2026
Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis, ClinicalTrials.gov ID NCT04921345
About the Writer
Aasritha Thippavajjala (Linkedin) is a pharm D student and aspiring medical writer with medical writing, clinical training experience and a strong interest in clinical research and patient safety She has hands-on exposure to clinical pharmacy activities including medication profile assessment, clinical case review, identification of potential drug-related problems, ADR awareness, patient counselling, and clinical documentation. She has also gained experience in medical literature review, evidence synthesis, and scientific communication through her published review article on digital twin-based patient simulation and her poster presentation at the 74th Indian Pharmaceutical Congress. Certified in ICH Good Clinical Practice (E6(R3)) and Scientific Writing in Health Research, she is passionate about applying her clinical knowledge and research skills to medical writing ,clinical research and contributing to accurate, evidence-based healthcare.