evaluation of nm26-2198 in healthy subjects and in patients with moderate-to-severe atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: this is a randomized, double-blind, placebo-controlled, single- and multiple ascending dose study of subcutaneous (sc) administration of nm26-2198 in healthy volunteers and adult patients with moderate to-severe ad to evaluate the safety, tolerability, pharmacokinetics (pk), and immunogenicity of single (sad) and multiple doses (mad) of nm26-2198.


Eligibility criteria:
inclusion criteria: 1. sad: non-asian ethnicity with grandparents and parents of non-asian descent or japanese descent having all four japanese grandparents born in japan. 2. sad and mad in healthy volunteers: male or female aged 18 to 55 years; mad: male or female ≥18 years of age. 3. all cohorts: weight of 45 kg to 100 kg and bmi of 18.0 to 30.0 kg/m2. 4. sad and mad in healthy volunteers: non-childbearing, non-breastfeeding females or males willing to use double barrier contraception or abstention from sex and sperm donation during the study; mad: males willing to use double barrier contraception or abstention from sex and sperm donation during the study; non-childbearing females or females of childbearing potential using protocol-defined method contraception, and who is not pregnant, lactating, or breastfeeding. 5. mad: diagnosis of chronic ad. 6. mad: easi score ≥16. 7. mad: viga-ad™ score of ≥3. 8. mad: atopic lesions cover ≥10% of body surface area (bsa). 9. mad: pp-nrs score ≥4. 10. mad: daily use of non-prescription emollient. note: other protocol-defined inclusion criteria apply. exclusion criteria: 1. sad and mad in healthy volunteers: any clinically-relevant medical history or lab abnormality, including positive test for sars-cov-2, hepatitis b or c, or hiv; mad: clinically-significant, abnormal laboratory findings, or positive test for sars-cov-2, hepatitis b or c, or hiv. 2. all cohorts: clinically important ecg abnormalities or history/evidence thereof. 3. sad and mad in healthy volunteers: use of prescription or non-prescription medications (except occasional use of paracetamol). 4. mad: diagnosis of protocol-specified skin diseases other than ad, or history of other significant skin condition that could interfere with study assessments. 5. mad: history or ongoing allergy/hypersensitivity or history, or history of hypersensitivity to biological drugs. 6. mad: recent receipt of immunoglobulin or blood products. 7. mad: recent treatment with protocol-specified investigational treatments, or any prior treatment with dupilumab, tralokinumab, lebrikizumab, nemolizumab, or other protocol-specified drugs. 8. mad: ad with recent ocular involvement requiring chronic ocular corticosteroid treatment. 9. mad: chronic pruritis due to conditions other than ad. 10. mad: acute ad superinfection, recent superficial skin infection, or other chronic/acute infection requiring protocol-defined treatments. 11. mad: recent use of sedating antihistimines, systemic corticosteroids, cytotoxic treatments, other immunosuppressive/immunomodulating agents, and other protocol-specified prohibited medications. 12. mad: recent topical corticosteroid or prescription moisturizer use. note: other protocol-defined exclusion criteria apply.