A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Exploratory Clinical Activity of NM26-2198 in Healthy Subjects and in Patients With Moderate-to-severe Atopic Dermatitis (AD)
Atopic Dermatitis
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria: SAD: Non-Asian ethnicity with grandparents and parents of non-Asian descent or Japanese descent having all four Japanese grandparents born in Japan. SAD: Male or female aged 18 to 55 years; MAD: Male or female ≥18 years of age. Weight of 45 kg to 100 kg and BMI of 18.0 to 30.0 kg/m2. SAD: 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. MAD: Diagnosis of chronic AD. MAD: EASI score ≥16. MAD: vIGA-AD™ score of ≥3. MAD: Atopic lesions cover ≥10% of body surface area (BSA). MAD: PP-NRS score ≥4. MAD: Daily use of non-prescription emollient. Note: Other protocol-defined Inclusion criteria apply. Exclusion Criteria: SAD: 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. Clinically important ECG abnormalities or history/evidence thereof. SAD: Use of prescription or non-prescription medications (except occasional use of paracetamol). MAD: Diagnosis of protocol-specified skin diseases other than AD, or history of other significant skin condition that could interfere with study assessments. MAD: History or ongoing allergy/hypersensitivity or history, or history of hypersensitivity to biological drugs. MAD: Recent receipt of immunoglobulin or blood products. MAD: Recent treatment with protocol-specified investigational treatments, or any prior treatment with dupilumab, tralokinumab, lebrikizumab, nemolizumab, or other protocol-specified drugs. MAD: AD with recent ocular involvement requiring chronic ocular corticosteroid treatment. MAD: Chronic pruritis due to conditions other than AD. MAD: Acute AD superinfection, recent superficial skin infection, or other chronic/acute infection requiring protocol-defined treatments. MAD: Recent use of sedating antihistimines, systemic corticosteroids, cytotoxic treatments, other immunosuppressive/immunomodulating agents, and other protocol-specified prohibited medications. MAD: Recent topical corticosteroid or prescription moisturizer use. Note: Other protocol-defined Exclusion criteria apply.
Sites / Locations
- California Clinical Trials Medical Group (CCTMG) managed by ParexelRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo
NM26-2198 10 mg
NM26-2198 50 mg
NM26-2198 150 mg
NM26-2198 300 mg
NM26-2198 400 mg
NM26-2198 600 mg
NM26-2198
Placebo (for NM26-2198) for subcutaneous (SC) injection on Day 1 (SAD and MAD), Day 8 (MAD only), Day 15 (MAD only), and Day 22 (MAD only).
NM26-2198 10 mg for SC injection on Day 1 (SAD)
NM26-2198 50 mg for SC injection on Day 1 (SAD)
NM26-2198 150 mg for SC injection on Day 1 (SAD)
NM26-2198 300 mg for SC injection on Day 1 (SAD)
NM26-2198 400 mg for SC injection on Day 1 (SAD)
NM26-2198 600 mg for SC injection on Day 1 (SAD)
NM26-2198 for SC injection on Days 1, 8, 15, and 22 (MAD). Doses to be determined based on observed safety and tolerability from SAD.