A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis (ADAPTIVE)

Prior treatment

• Active acute or chronic infection (including skin infection) requiring treatment with topical or systemic antibiotics, antivirals, antifungals, antiparasitic or antiprotozoals within 2 weeks prior to the Baseline (Day 1) visit.
• Previous participation in a study using IMG-007 as the study treatment

Other illness

• Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) serology results at Screening visit
• Evidence of active or latent tuberculosis (TB) as confirmed by the screening TB blood test
• History of untreated or inadequately treated TB infection
• Active unstable (e.g., in an acute flare) pruritic skin conditions or other skin diseases in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgment

Lab values

• Presence of severe cardiovascular, pulmonary, renal, autoimmune, or metabolic illness(es), or any other acute or chronic medical or psychiatric condition or laboratory abnormality
• Clinically significant abnormal laboratory values at screening

• Male or female aged ≥ 18 (or at age where legally considered adult locally) and < 71 years
• Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study
• Clinically confirmed diagnosis of AD (according to the American Academy of Dermatology Consensus diagnostic criteria) with a disease history of at least 1 year before the Screening visit (information obtained from medical chart or subject’s physician, or via participant interview)
• Active moderate-to-severe AD
• Documented history (within 6 months of screening) of inadequate response to or lack of tolerability of, as assessed by the investigator, a stable regimen of one or more topical treatments, e.g., topical corticosteroids (TCSs) and/or topical calcineurin inhibitors (TCIs) before the Screening visit, or for whom topical treatments are otherwise inadvisable
• Agree to apply a stable dose of a non-medicated emollient (moisturizer)
• Female participants must not be pregnant or breastfeeding and must meet at least one of the following conditions: a) Not of childbearing potential, OR b) Of childbearing potential and agree to use a highly effective method of contraception
• Male participants must agree to use a highly effective method of contraception or must be surgically sterilized
• The weekly mean of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥ 4 during the 7-day period immediately prior to randomization at the Baseline (Day 1) visit