Dermatology company Galderma (SIX:GALD) on Thursday announced Phase II study results showing that nemolizumab improved itch severity, sleep disturbance and quality of life in children aged 2 to 11 with moderate-to-severe atopic dermatitis, with benefits sustained through Week 52.
The findings will be presented at the Pediatric Dermatology Research Alliance (PeDRA) Annual Conference.
The multicentre, open-label study evaluated nemolizumab's pharmacokinetics, safety and efficacy in paediatric patients receiving weight-based dosing alongside topical therapy. At Week 16, itch response rates ranged from 56% to 72% across study cohorts, while sleep disturbance scores improved by 70% to 78%, with similar or greater benefits maintained at Week 52.
At Week 52, Children's Dermatology Life Quality Index scores improved by 10.7 to 12 points across cohorts, with additional quality-of-life gains reported using age-appropriate assessment measures. Nemolizumab was well tolerated, and the study identified no new safety signals.
These findings add to the clinical evidence for nemolizumab, which has multiple global approvals for adults and paediatric patients aged 12 and older with moderate-to-severe atopic dermatitis, as well as adults with prurigo nodularis. Galderma noted that treatment options remain limited for younger children with moderate-to-severe atopic dermatitis, a condition that can disrupt sleep, schooling and social confidence.
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