A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety profile of various dose regimens of IMG-007 in adult participants with moderate-to-severe active atopic dermatitis (AD) up to 48 weeks.
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Moderate-to-severe AD
Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable
Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception
Male participants must agree to use a highly effective method of contraception
EASI score ≥16
vIGA-AD score ≥3
≥10% body surface area (BSA) of AD involvement
Mean peak pruritus numerical rating scale ≥ 4 during 7-days before randomization
You may not be if
Positive hepatitis B, hepatitis C, or human immunodeficiency virus infection
Evidence of active or latent tuberculosis (TB)
History of untreated or inadequately treated TB infection
Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals
Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement
Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study
Having received any of the specified therapies within the specified timeframe(s) prior to the Baseline visit
