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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07465120
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-75 years, willing to sign the ICF
* Clinical diagnosis of AD (Hanifin \& Rajka criteria) for ≥1 year
* At screening and baseline, EASI score ≥ 16 points, IGA ≥ 3, BSA ≥ 10%, Itch NRS ≥ 4
* Documented history of inadequate response to topical corticosteroids (TCS) or -topical calcineurin inhibitors (TCI).
* Subject has applied a topical emollient (moisturizer) daily for at least 7 days prior to the Baseline Visit.
Exclusion Criteria:
* Other active skin conditions that may interfere with AD assessment.
* History of a serious bacterial, fungal, or viral infection requiring hospitalization or intravenous antimicrobial therapy within 3 months prior to the first dose.
* History of a bacterial, fungal, or viral infection requiring oral antimicrobial therapy within 4 weeks prior to the first dose.
* Active infection or acute illness within 7 days prior to the first dose.
* Chronic or recurrent infectious diseases at screening or baseline that may increase safety risks.
* Evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
* History of a major or unstable clinical condition within 6 months prior to the first dose, which would compromise participation.
* History of malignant tumour within 5 years before screening.
* Previous or current autoimmune diseases.
* Positive results of confirmatory test for hepatitis B, hepatitis C, human
* immunodeficiency virus (HIV) or syphilis.
* Allergic to any component of the investigational drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07465120
Study Brief:
Protocol Section:
NCT07465120