Comparing 6 approaches for atopic dermatitis

Exclusion

• −History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class;
• −HIV infection defined as confirmed positive anti- HIV Ab test;
• −Participants with current or past history of infection including, Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV);
• −Meeting any of the following conditions at BaselineBaselineYour starting measurements, taken before treatment begins.Read more →:
• −Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline Visit or would interfere with assessment of AD lesions;
• −Two or more past episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
• −One or more past episodes of disseminated herpes simplex (including eczema herpeticum);
• −Active TB or meet TB exclusionary parameters (specific requirements for TB testing are provided in the operations manual);
• −For Japan: Positive result of beta-D-glucan (screeningScreeningThe checks done before joining, to see whether a study fits.Read more → for Pneumocystis jirovecii infection) or two consecutive indeterminate results of beta-D-glucan during the Screening Period;
• −Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit;
• −Chronic recurring infection and/or active viral infection that, based on the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s clinical assessment, makes the subject an unsuitable candidate for the study;
• −COVID-19 infection: In subjects who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the Baseline visit of asymptomatic subjects. Subjects with mild/moderate COVID-19 infection can be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Subjects may be rescreened if deemed appropriate by the investigator based upon the subject's health status.
• −At Baseline any of the following medical diseases or disorders:
• −Any unstable clinical condition which, in the opinion of the investigator would put the subject at risk by participating in the protocolProtocolThe detailed plan a study must follow.Read more →;
• −Diagnosed active parasitic infection, suspected or high risk of parasitic infection unless clinical (and if necessary) laboratory assessment have ruled out active infection before randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →;
• −History of an organ transplant which requires continued immunosuppression;
• −History of GI perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;
• −History of malignancy except for successfully treated NMSC or localized carcinoma in situ of the cervix.
• −Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery or venous thromboembolism;
• −Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery including sleeve gastrectomy; subjects with a history of gastric banding/segmentation are not excluded;