Phase 2Â findings support weight-based dosing and sustained efficacy through 52 weeks, with no unexpected adverse events in children aged 2-11 with moderate-to-severe atopic dermatitis.
TouchDERMATOLOGY coverage from AAD 2026:
With four presentations exploring the use of nemolizumab across different populations with atopic dermatitis (AD), it was certainly a therapy to watch at this year’s AAD 2026 meeting. Among these was the much-anticipated late-breaking presentation of phase 2 pharmacokinetic, efficacy and safety data for nemolizumab in pediatric patients aged 2–11 years with moderate-to-severe AD (NCT04921345).
Nemolizumab, the first approved monoclonal antibody specifically targeting and inhibiting IL-31 signalling, has already demonstrated efficacy and safety in adults and adolescents with moderate-to-severe AD when used in combination with topical agents, including reductions in pruritus and improvements in quality of life. However, data supporting its use in children under 13 years of age have been lacking, despite AD being common in this population.
To learn first-hand what the data from this study have shown, and what they could mean for clinicians and the many young patients living with moderate-to-severe AD, we spoke with study investigator Dr Linda Stein Gold (Henry Ford Health, Detroit, MI, USA), who presented the key findings at the meeting.
Abstract: Stein Gold L. Pharmacokinetics, safety, and efficacy of nemolizumab in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis. S023 Late-Breaking Research: Session 1. AAD 2026, 27-31 March, Denver, CO, USA.
Transcript:
Q. What factors should be considered when deciding which therapy to prescribe for young children with atopic dermatitis?
When we’re treating our younger patients with AD, we have to realize that this is a disease that has a tremendous impact on their overall quality of life. For a lot of our patients, they’re not sleeping. If they’re not sleeping, that means their family’s not sleeping. And I really feel like we have to make sure that we are aggressive enough in getting these patients under control. So if these patients are being treated with topicals and we are really not getting their itch under control and their rash under control and their sleep under control, it’s really important to move to a systemic agent.
Q. What is currently known about the safety and efficacy of nemolizumab in atopic dermatitis?
Nemolizumab is a biologic agent that targets the receptor for IL-31. And we think of IL-31 as the itch cytokine. But it is actually so much more than that. We know it has an impact on creating skin barrier disruption. It also has an impact on inflammation. And by blocking IL-31 and its messaging, nemolizumab is able to actually help these patients with moderate-to-severe AD get both the itch and the rash under control, and this has been studied and approved in patients down to age 12 with moderate-to-severe AD.
Q. What were the aims, design and eligibility criteria of the pediatric study?
The paediatric study was conducted looking at patients between the ages of two and 11, and the goal was to get efficacy and safety information in this younger pediatric population. And really the primary goal was to look at the pharmacokinetics of this drug and make sure that it was similar in this younger population to what we found in the adolescent and adult population. And the patients who came into this trial were really put in two different cohorts. The first was the older cohort, ages 7 to 11. And the study was done first on this older cohort. And once the safety and efficacy was confirmed, then the younger cohort was enrolled. And we looked at pretty much standard moderate-to-severe AD criteria. They had to be between the ages of two and 11. They had to have an Eczema Area Severity Index (EASI) score of at least 16. Their Investigator’s Global Assessment had to be moderate or worse, and they had to have at least 10% body surface area of involvement, and their itch score (measured by Peak Pruritus-Numerical Rating Scale [PP-NRS] score) had to be at least a four. Their weight had to be at least 10 kg. And these patients couldn’t have a recent history of asthma exacerbation requiring hospitalization or uncontrolled asthma in the past three months. And also they couldn’t have a history of chronic bronchitis. And then they had to have the standard washouts for prior treatments.
Q. How did nemolizumab perform in terms of the key endpoints, and what did the safety evaluation show?
What we found in terms of pharmacokinetics in the younger population was the first dose that we looked at actually was a little bit too high. So we went back and we cut the dose in half, and the dose was weight-based. And what we then found was with this lower dose, the pharmacokinetics fell well within what we found with the adolescents and the adult population in the phase 3 clinical trials.
When we look first at the efficacy of nemolizumab in this younger population, what is first is it’s interesting that even though we cut the dose in half to really get a better pharmacokinetic profile, that didn’t affect the efficacy. We actually found better efficacy in the lower dosing than we did in the higher dosing. And this drug really achieved fairly rapid onset in terms of Investigator’s Global Assessments of clear or almost clear. And we saw a nice improvement over time. And we saw consistent improvement over the course of 52 weeks. We saw that in terms of getting to clear or almost clear, also in terms of getting to an EASI 75. And when we look at itch reduction, that also kicked in very, very rapidly. We saw, especially in our younger population, at week 2, more than half of these patients had a four-point reduction in their worst itch, and that continued to improve. We saw rapid improvement in itch and sustained improvement over the course of 52 weeks.
Then when we look at the side effect profile, what we found was the side effects were really not outside of what we would expect when looking at a pediatric population over the course of the year. The treatment-emergent adverse events were low, mainly included some infections, and overall the drug was deemed to be safe and effective, and this data supports a potential use in this pediatric population.
Q. What do these findings mean for clinical practice?
I think it’s really important that we study our systemic agents in our younger patient population who have moderate-to-severe AD. These patients are suffering, and we have to have options that have been proven both safe and effective in this population and with the data based on nemolizumab looking at patients aged 2 to 11, we found that this drug was safe and effective and should be a good option for our treatments in this younger patient population.
Abstract. Stein Gold L. Pharmacokinetics, safety, and efficacy of nemolizumab in children (aged 2 to 11 years) with moderate-to-severe AD. S023 Late-Breaking Research: Session 1. AAD 2026, 27-31 March, Denver, CO, USA.
Disclosures: Linda Stein Gold has acted as an advisor, speaker and/or investigator for Abbvie, Amgen, Arcutis, BMS, Lilly, Johnson &Johnson, Pfizer, Regeneron, Sanofi, Takeda, and UCB.
This content has been developed independently by Touch Medical Media for touchDERMATOLOGY. It is not affiliated with the American Academy of Dermatology. Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media.
Cite: New data highlight potential role of nemolizumab in pediatric atopic dermatitis. TouchDERMATOLOGY. 12 July 2026.
Editor: Gina Furnival
