Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT05369403
Eligibility Criteria:
Inclusion Criteria:
* All participants must have prior treatment with dupilumab meeting one of the following conditions:
* Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab (at labeled dose level) for at least 4 months.
* Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment.
* Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment.
* Participants who have chronic AD that has been present for ≥1 year before screening.
* Have EASI ≥16 at baseline
* Have IGA score ≥3 (Scale of 0 to 4) at baseline
* Have ≥10% body surface area (BSA) of AD involvement at baseline
* Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
* Adolescents body weight must be ≥40 kg at baseline.
Exclusion Criteria:
* History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
* Have a current infection or chronic infection with hepatitis B virus (HBV) at screening (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA
* Have a current infection with hepatitis C virus (HCV) at screening (that is, positive for HCV RNA
* Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator.
* Have uncontrolled asthma that
* might require bursts of oral or systemic corticosteroids, or
* required the following due to ≥1 exacerbations within 12 months before baseline
* systemic (oral and/or parenteral) corticosteroid treatment, or
* hospitalization for \>24 hours.
* Have known liver cirrhosis and/or chronic hepatitis of any etiology.
* Had Dupilumab treatment within 4 weeks prior to baseline
* Had prior treatment with tralokinumab.
* Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline
* Treatment with any of the following agents within 4 weeks prior to the baseline
* systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants)
* small molecules (e.g. JAK inhibitors)
* phototherapy and photochemotherapy for AD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05369403
Study Brief:
Protocol Section:
NCT05369403