PeDRA 2026: Nemolizumab Phase II Data Show Long — Term Symptom Relief for Children Aged 2 to 11 Years With Moderate — to — Severe Atopic Dermatitis
For best results when printing this announcement, please click on link below: PeDRA 2026: Nemolizumab Phase II Data Show Long-Term Symptom Relief for Children Aged 2 to 11 Years With Moderate-to-Severe Atopic Dermatitis Patient-reported outcomes from a phase II study of nemolizumab in children aged 2 to 11 with moderate-to-severe atopic dermatitis show meaningful reductions in itch severity, better sleep and improved quality of life, maintained for a year(1) Currently, there are limited approved treatment options for children living with moderate-to-severe atopic dermatitis, despite the high unmet need — the disease can significantly reduce quality of life for children and create burden on their families(2-8) These findings expand on the clinical evidence base for nemolizumab, which has multiple global approvals for adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis, and adults with prurigo nodularis(9,10) Galderma (SIX: GALD), the pure-play dermatology category leader, today announced new phase II data showing that nemolizumab provided meaningful improvements in itch, sleep disturbance, and quality of life in children aged 2 to 11 year
(1) The results will be presented at The Pediatric Dermatology Research Alliance (PeDRA) Annual Conference. This press release features multimedia. (3) “The burden of atopic dermatitis on children and their families remains considerable, with symptoms affecting quality of life, emotional wellbeing and day-to-day functioning. There is a continued need for treatment options that can deliver meaningful benefits for patients with moderate-to-severe disease.
d. (1) Children were enrolled into three cohorts based on age and weight, and received weight-tiered nemolizumab dosing plus topical therapy. Patient-reported outcomes and quality of life results demonstrated meaningful improvements in itch, sleep disturbance, and quality of life, sustained through Week 52:(1) Improvements in itch were achieved early in treatment and sustained over one year of follow-up, with Peak Pruritus Numerical Rating Scale four point-response rates between 56%-72% across cohorts at Week 16, and similar and/or higher responses seen at Week 52.
Reductions in sleep disturbance as measured by the Sleep Disturbance Numerical Rating Scale were similarly achieved early in treatment and maintained through Week 52, with scores improving by -70 to -78% across cohorts at Week 16, and further improvements at Week 52. 0 from baseline at Week 52 across cohorts. Improvements were also observed in both age-appropriate quality of life measures, including the Infants’ Dermatitis Quality of Life index (for children <4 years) and Patient-Oriented Eczema Measure (for children ≥4 years). Nemolizumab was well tolerated, with no new safety signals.
(9,10) “At Galderma, we are committed to advancing science-based solutions for atopic dermatitis, supporting patients and their families through continued research and innovation, with the goal of delivering treatment options that can meaningfully improve quality of life. d. , Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan.
(9) To date, nemolizumab is approved for both adolescents and adults with moderate-to-severe atopic dermatitis and adults with prurigo nodularis in more than 40 countries around the world. Additional regulatory submissions and reviews are ongoing. Nemluvio Important Safety Information INDICATIONS: NEMLUVIO® (nemolizumab-ilto) is an interleukin-31 receptor alpha antagonist indicated for: the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.
the treatment of adults with prurigo nodularis. CONTRAINDICATION: NEMLUVIO is contraindicated in patients with known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO. WARNINGS AND PRECAUTIONS: Hypersensitivity reactions have been reported with NEMLUVIO use. If clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy, and discontinue NEMLUVIO.
Avoid use of live vaccines during treatment with NEMLUVIO. ADVERSE REACTIONS: Most common adverse reactions (incidence ≥1%) are: Atopic Dermatitis: headache (including migraine), arthralgia, urticaria, and myalgia. Prurigo Nodularis: headache, dermatitis atopic, eczema, and eczema nummular. Use In Specific Populations: Pregnancy: There are no adequate and well-controlled studies on NEMLUVIO in pregnant women.
The limited available information on NEMLUVIO use during pregnancy is not sufficient to inform a drug-associated risk of major birth defects or miscarriage in humans. Human IgG antibodies are known to cross the placental barrier; therefore, NEMLUVIO may be transmitted from the mother to the developing fetus. Lactation: There are no data on the presence or transfer of NEMLUVIO in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk.
The effects of local gastrointestinal and limited systemic exposure to NEMLUVIO on the breastfed infant are unknown. NEMLUVIO has not been administered to nursing/lactating women. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NEMLUVIO and any potential adverse effects on the breastfed child from NEMLUVIO or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of NEMLUVIO have not been established in pediatric patients younger than 12 years of age for the treatment of moderate-to-severe atopic dermatitis or pediatric patients younger than 18 years of age for the treatment of prurigo nodularis. Please see full Prescribing Information including Patient Information. About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries.
We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ — the skin — meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: References 1.
Eichenfield LF, et al. Patient-Reported Outcomes and Quality of Life in Pediatric Patients (Aged 2—11 Years) with Moderate-to-Severe Atopic Dermatitis Treated with Nemolizumab. Abstract presented at The Pediatric Dermatology Research Alliance (PeDRA) Annual Conference; October 15-17, 2026; United States. 2.
Schoch JJ, et al. Atopic dermatitis: Update on skin-directed management: clinical report. Pediatrics. 2025; 155(6):e2025071812.
2025-071812. 3. Eichenfield LF, et al. Patient-reported impact of atopic dermatitis on pediatric and adolescent patients with moderate-to-severe disease: results of a real-world, cross-sectional survey.
Pediatr Dermatology. 2025;42:523-531. 15940. 4.
Vittrup I, et al. The association between atopic dermatitis, cognitive function and school performance in children and young adults. Br J Dermatol. 2023;188(3):341-349.
1093/bjd/ljac058. 5. Mostafa N and Smith S D. Improving psychological health outcomes in children with atopic dermatitis.
Clin Cosmet Investig Dermatol. 2023;16:2821-2827. S393254. 6.
Stingeni L, et al. Atopic Dermatitis and Patient Perspectives: Insights of Bullying at School and Career Discrimination at Work. J Asthma Allergy. 2021;14:919-928.
S317009 7. Kelly K A, et al. Skin disease in children: Effects on quality of life, stigmatization, bullying, and suicide risk in pediatric acne, atopic dermatitis, and psoriasis patients. Children (Basel).
2021;8(11):1057. 3390/children8111057. 8. Lee D G, et al.
Sleep Disturbances in Children With Atopic Dermatitis: A Scoping Review. J Cutan Med Surg. 2023;27(2):157-164. 1177/12034754231159337.
9. S. Prescribing Information. Available online.
Accessed October 2026. 10. Nemluvio® European Medicines Agency. Summary of Product Characteristics.
Available online. Accessed October 2026. 11. Jennifer J, et al.
Atopic Dermatitis: Update on Skin-Directed Management: Clinical Report. Pediatrics. 2025;155(6):e2025071812. 2025-071812.
12. Shaw TE, Currie GP, Koudelka CW, Simpson EL. Eczema prevalence in the United States: data from the 2003 National Survey of Children’s Health. J Invest Dermatol.
2011;131(1):67-73. 13. Silverberg, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus.
J Allergy Clin Immunol. 2020;145(1):173-182. 013. 14.
Bewley, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039-2048.
1007/s13555-022-00782-2. 15. , Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis.
Available online. Accessed October 2026. 16. , Ltd.
Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed October 2026. Sc.
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