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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT06881251
Eligibility Criteria:
Inclusion criteria:
* Chronic Atopic Dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to the screening visit
* Eczema Area and Severity Index (EASI) score greater than and equal to (\>=) 16 at the screening and baseline visits
* Validated investigator global assessment for AD (vIGA-AD) score \>= 3 at the screening and baseline visits
* \>= 10% body surface area (BSA) of AD involvement at the screening and baseline visits
* Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of \>=4
* Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, or inadequate response to systemic therapies (within 12 months before screening)
* Participant has applied a moisturizer at least once daily for at least 7 days before the baseline visit
Exclusion criteria:
* Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents (eg, severe ocular surface disease, dupilumab-associated facial redness) inhibiting IL-4Rα, IL-4, and/or IL-13 signaling (eg, dupilumab, lebrikizumab, or tralokinumab)
* Participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study
* Active skin disease other than AD including eczema herpeticum, molluscum contagiosum, impetigo, psoriasis or has any other ongoing significant skin condition including skin infections, that, according to the investigator, could interfere with efficacy assessments
* Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, or history of recurrent eczema herpeticum
* History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, untreated latent tuberculosis), recurrent urinary tract infection, fungal infection, mycobacterial infection, or open, draining, or infected skin wounds, or ulcers.
* Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization
* Had major surgery (eg, requiring general anesthesia and hospitalization), within 8 weeks before screening, or will not have fully recovered from surgery, or has such surgery planned during the time the participant is expected to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06881251
Study Brief:
Protocol Section:
NCT06881251