Phase 2 Eczema Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 to 75 years at the time of signing the consent form, of any gender
• People who have been diagnosed with atopic dermatitis (eczema) according to recognised medical criteria, with a history of the condition for at least 6 months before the screening visit, and whose eczema has been considered stable in the 4 weeks before signing the consent form
• People whose eczema severity falls within a mild-to-moderate range, based on a standard medical scoring scale (vIGA-AD score of 2–3), measured at both the screening and baseline visits
• People whose eczema activity score (EASI score) falls between 5 and 21 at both the screening and baseline visits
• People whose eczema affects a specific portion of their body surface area at both screening and baseline — either 5%–20% (Cohort 1) or 15%–25% (Cohort 2) — with lesions suitable for a cream or ointment applied to the skin
• Women who could become pregnant, and men, who are willing to use at least one highly effective form of contraception or abstain from sex from the time of signing the consent form until 3 months after the last dose of the study treatment
• People who voluntarily agree to take part and sign the informed consent form

Who may not be able to join:

• People who have skin conditions or abnormalities at the area where the study treatment would be applied that could interfere with assessing how the treatment is working
• People with other significant skin diseases — such as psoriasis, acne, or skin cancer — that are not compatible with the study or would affect how the treatment site is assessed
• People who have autoimmune conditions other than eczema (such as inflammatory bowel disease or rheumatoid arthritis) that the study doctor believes would interfere with the trial results
• People with a current or past history of lymphoproliferative disorders (conditions affecting lymph tissue), or symptoms such as swollen lymph nodes or an enlarged spleen that may suggest such a condition
• People with any current cancer, or a history of cancer within the 5 years before screening (with some exceptions for certain fully treated cancers — confirm with trial site)
• People with a herpes virus infection in the past 6 months, a history of recurring shingles (2 or more episodes), widespread herpes zoster or herpes simplex, or a suspected current herpes infection that cannot be ruled out
• People who required hospitalisation for a serious infection within 12 weeks before screening, or who have an active infection requiring treatment within 4 weeks before screening
• People with a local active skin infection within 1 week before screening, such as an infected eczema area or a superficial skin infection requiring antibiotic, antifungal, or antiviral medication taken by mouth or by injection
• People with a history of blood clots (such as deep vein thrombosis or pulmonary embolism), or factors that significantly raise the risk of blood clotting (such as prolonged immobility), where the study doctor judges participation to be unsuitable
• People with a significant history of heart, neurological, breathing, blood, digestive, urinary, immune, or mental health conditions that the study doctor believes could affect the results or the safety of participation
• People with a history of drug or substance abuse
• People who have used prescription skin treatments for eczema or eczema-related skin infections at the treatment area within 2 weeks before the baseline visit — including topical steroids, topical calcineurin inhibitors, topical PDE-4 inhibitor ointments, or topical antimicrobials
• People who have used topical skin products containing active ingredients (such as vitamin E, niacinamide, urea, or ceramide) at the treatment area within 1 week before the baseline visit (plain moisturisers without active ingredients are permitted)
• People who have taken systemic (whole-body) treatments for eczema within 4 weeks or 5 half-lives (whichever is longer) before the baseline visit, including systemic anti-infective medicines, PDE-4 inhibitors, or systemic traditional Chinese or herbal medicines for eczema
• People who have used JAK inhibitor medications (such as ruxolitinib, baricitinib, upadacitinib, abrocitinib, or similar) by any route within 12 weeks before the baseline visit
• People who have used sedating antihistamines within 2 weeks before the baseline visit (stable use of non-sedating antihistamines may be permitted — confirm with trial site)
• People who have used systemic immunosuppressants or immunomodulators (such as oral or injectable steroids, methotrexate, cyclosporine, or azathioprine) within 4 weeks or 5 half-lives (whichever is longer) before the baseline visit
• People who have used biologic medicines (such as dupilumab) within 12 weeks or 5 half-lives (whichever is longer) before the baseline visit
• People who have used strong CYP450 enzyme inhibitor or inducer medicines (certain antiviral, antibiotic, antifungal, or other medications — confirm with trial site) within 2 weeks before the baseline visit
• People who have received a live or live-attenuated vaccine within 4 weeks before the baseline visit, or who plan to receive one during the study period
• People who have had sun tanning or phototherapy treatments with therapeutic effects on eczema within 4 weeks before the baseline visit
• People with certain abnormal blood test results at screening, including low white blood cell counts, low neutrophil or lymphocyte counts, low platelet counts, or low haemoglobin levels (specific thresholds apply — confirm with trial site)
• People with significantly elevated liver enzyme levels (AST or ALT) or elevated bilirubin levels on blood tests at screening
• People with significantly elevated creatinine levels (a kidney function marker) on blood tests at screening
• People with confirmed or suspected active tuberculosis, or incompletely treated tuberculosis, unless documented adequate treatment has been completed (confirm with trial site)
• People whose heart rhythm test (ECG) at screening shows a QTcF interval of 500 ms or more
• People who test positive for hepatitis B surface antigen, or who have certain other hepatitis B, hepatitis C, HIV, or syphilis test results indicating active or unresolved infection (specific test combinations apply — confirm with trial site)
• People with a known or suspected allergy to the study treatment or any of its ingredients
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period
• People who have had major surgery within 4 weeks before the baseline visit, or who have planned surgery during the study
• People who have experienced significant blood loss, received a blood transfusion, or donated 400 mL or more of blood within 3 months before the baseline visit
• People who have participated in another clinical trial within 3 months before the baseline visit
• People who have consumed more than 14 units of alcohol per week within 3 months before screening (approximately equivalent to more than 4 standard drinks per day — confirm with trial site)
• People who the study doctor considers unsuitable for any other reason

Important: Always verify eligibility with the trial site directly before applying.