Nemolizumab

Nemolizumab, a first-in-class humanized monoclonal antibody, is directed against the IL-31 receptor alpha (see IL-31RA gene below), which blocks the signal transmission of interleukin-31 .

Atopic dermatitis: Chugai Pharmaceutical Co, Ltd (TOKYO: 4519) recently announced that long-term data from a Phase II study (264 patients) of nemolizumab (CIM331) showed that nemolizumab is effective in moderate to severe atopic dermatitis. It has since been confirmed that the tolerability and efficacy of nemolizumab was maintained after one year of continuous treatment (Kabashima K et al. 2018).

Results of a 2-year study (ARCADIA) demonstrate a consistent safety profile on the one hand and a sustained and increasing improvement (skin lesions, itching, sleep, quality of life) in atopic dermatitis on the other (Silverberg JI et al. 2025).

Prurigo nodularis: Furthermore, a phase 2 study published in the New England Journal of Medicine (NEJM) was published in which nemolizumab was successfully used in adult patients with moderate to severe prurigo nodularis (PN) (Ruzicka T et al. 2017; Ständer S et al. 2020). In this study, 70 patients were successfully treated with subcutaneous nemolizumab (0.5 mg/kg every 4 weeks). At week 18 (10 weeks after the last dose), 38% of patients treated with nemolizumab were free or almost free of prurigo nodularis, compared to 6% of patients receiving placebo. Nemolizumab was well tolerated. ADRs described were gastrointestinal discomfort, diarrhea and muscular symptoms. However, no imbalance was observed between the verum and placebo groups.

Nemolizumab is approved for the indication atopic dermatitis and chronic prurigo (^{Nemluvio®-Fa}. Galderma).

1. Kabashima K et al. (2018) Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. J Allergy Clin Immunol 142:1121-1130
2. Ruzicka T et al.(2017). Anti- Interleukin-31 Receptor A Antibody for Atopic Dermatitis. N Engl J Med 376:826-835.
3. Silverberg JI et al. (2025) Patients' Experiences of Atopic Dermatitis and Nemolizumab Treatment: An In-Trial Interview Study Embedded in a Phase 3 Clinical Trial (ARCADIA). Patient 18: 511-521.
4. Ständer S et al. (2020) Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. N Engl J Med 382:706-716.