Nemolizumab Shows Efficacy in Pediatric Atopic Dermatitis

Nemolizumab, an IL-31 receptor alpha (IL-31Rα) antagonist, demonstrated favorable pharmacokinetics, sustained efficacy, and a consistent safety profile in children aged 2 to 11 years with moderate-to-severe atopic dermatitis (AD), according to Phase 2 data presented by Linda Stein Gold, MD, at the American Academy of Dermatology (AAD) 2026 Annual Meeting.

The 52-week, open-label, single-arm study enrolled 109 pediatric patients across three cohorts stratified by age and weight. The primary objective was to evaluate pharmacokinetics and safety, with efficacy assessed through validated endpoints including Investigator’s Global Assessment (IGA), Eczema Area and Severity Index (EASI), and pruritus measures.

Nemolizumab targets IL-31, a key cytokine in itch and inflammation.

“IL-31 is the itch cytokine, but it is so much more than that,” Dr. Stein Gold said. “It is involved with barrier dysfunction. It is also involved in inflammation.” 

Pharmacokinetic analyses showed that adjusted, weight-based dosing achieved systemic exposures comparable to those observed in adolescents and adults. Early dosing adjustments were required, as initial higher doses resulted in greater-than-expected exposure.

“When we look at the systemic exposures, once the dose was adjusted, it was very well matched in terms of the PK analysis to the adolescents and adults that were studied in the prior nemolizumab clinical trials with moderate-to-severe atopic dermatitis,” Dr. Stein Gold noted. 

Clinical responses were observed early and sustained over time. Improvements in itch were seen as early as Week 1, with continued benefit through Week 52.

“As we would expect when we look at itch, we saw a rapid onset of action,” Dr. Stein Gold said. “The youngest age cohort did have even a better response with an earlier kick in. We know that the itch parameters were assessed by the caregiver, but again, a very nice maintenance of effect over the course of 52 weeks.”

At Week 16, IGA success rates ranged from 40.5% to 47.2% across cohorts, with EASI-75 responses up to 73%. By Week 52, response rates were similar or higher, with approximately 80% of patients achieving EASI-75.

Nemolizumab was well tolerated, with no serious adverse events reported. Two severe adverse events occurred (AD exacerbation and eosinophilia), both resolving.

“We don’t see any adverse events that would be unexpected for this patient population,” Dr. Stein Gold said.