Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Key Inclusion Criteria:

• Male or female subjects aged greater than and equal to (>=) 12 years at thescreening visit.

• Chronic atopic dermatitis (according to American Academy of Dermatology ConsensusCriteria) that has been present for at least 2 years before the screening visit.

• Eczema Area and Severity Index (EASI) score >=16 at the screening and baselinevisits.

• Investigator Global Assessment (IGA) score >= 3 (scale of 0 to 4) at the screeningand baseline visits.

• AD involvement >= 10 percent (%) of body surface area (BSA) at screening andbaseline visits.

• Peak Pruritus Numerical Rating Scale (PPNRS) score of at least 4.0 at the screeningand baseline visit.

• Documented recent history of inadequate response to topical medications (topicalcorticosteroids [TCS] with or without Topical calcineurin inhibitors [TCI]).

• Female subjects of childbearing potential (that is, fertile, following menarche anduntil becoming postmenopausal unless permanently sterile) must agree either to bestrictly abstinent throughout the study and for 12 weeks after the last study druginjection, or to use an adequate and approved method of contraception throughout thestudy and for 12 weeks after the last study drug injection.

Key Exclusion Criteria:

• Body weight (<) 30 kilograms (kg).

• Exacerbation of asthma requiring hospitalization in the preceding 12 months.Uncontrolled asthma in the preceding 3 months.

• Cutaneous infection within 1 week before the baseline visit, any infection requiringtreatment with oral or parenteral antibiotics, antivirals, antiparasitics orantifungals within 2 weeks before the baseline visit, or any confirmed or suspectedcoronavirus disease (COVID)-19 infection within 2 weeks before the screening orbaseline visit.

• Pregnant women, breastfeeding women, or women planning a pregnancy during theclinical study.

Note: Subjects with chronic, stable use of prophylactic treatment for recurrent herpes viral infection can be included in this clinical study.

• History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, example, monoclonal antibody) or to any of the studydrug excipients.

• Any clinically significant issue, based on investigator judgement.