Phase 2 Eczema Trial, Terminated

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

Who might be able to join this trial:

• A doctor has confirmed a diagnosis of atopic dermatitis (eczema) that has not been adequately controlled with creams or ointments applied to the skin.
• Eczema severity scores at the screening and randomization appointments must meet specific thresholds set by the trial (confirm with trial site for exact score details).
• A doctor has rated the eczema as moderate or severe (a score of 3 or 4 out of 4) at both the screening and randomization appointments.
• Eczema must be covering at least 8% of the body at screening and at least 10% of the body at randomization.
• Itch levels must be rated at least 4 out of 10 on average over the 7 days before the randomization appointment.
• There is a documented history within the past 6 months showing that skin-applied treatments did not work well enough, or a medical reason exists why those treatments cannot be used.
• A plain moisturiser (emollient) must have been applied twice daily for at least 7 days in a row immediately before the randomization appointment.
• Participants must be willing and able to complete daily self-reported questionnaires — at least 70% of them between the first two visits, and at least 5 out of 7 in the week before the second visit.
• Women who could become pregnant must agree to use a highly effective form of contraception from randomization through to 16 weeks after the last dose, and must have a negative pregnancy blood test at the first visit.
• Women who cannot become pregnant are defined as those who have had a hysterectomy, both ovaries removed, or both fallopian tubes removed, or who meet specific criteria for being postmenopausal (confirm with trial site for age-specific details).

Who may not be able to join:

• People with other active skin conditions (such as psoriasis or seborrheic dermatitis) that a doctor believes could interfere with study assessments.
• People with a known active allergic or irritant skin reaction (contact dermatitis) that a doctor believes could interfere with study assessments.
• People with a current or past cancer diagnosis, unless it was a skin basal cell carcinoma, localised skin squamous cell carcinoma, or cervical carcinoma in situ that was fully treated at least 12 months ago and is in remission — or for other cancer types, fully treated and in remission for at least 5 years.
• People with any unstable serious medical condition (such as heart, liver, kidney, neurological, or psychiatric conditions) that a doctor believes could affect safety, influence results, or prevent participation for the full study duration.
• People with a history of a severe allergic reaction (anaphylaxis) to any biologic therapy or vaccine.
• People diagnosed with a parasitic worm (helminth) infection within the past 24 weeks that has not been successfully treated.
• People with clinically significant abnormal results from physical examinations, blood tests, or urine tests during screening that, in the doctor's opinion, could pose a risk or affect study results.
• People with active liver disease; however, stable chronic hepatitis B or C or other stable chronic liver disease may be acceptable if other criteria are met (confirm with trial site).
• People with certain elevated liver enzyme levels (ALT or AST) at 3 or more times the upper limit of normal, confirmed by repeat testing (confirm with trial site).
• People with a known immune deficiency disorder or a positive HIV test.
• People who have used topical eczema treatments (such as steroid creams, calcineurin inhibitor creams, or PDE4 inhibitor creams) within 7 days before the randomization appointment.
• People who started using prescription moisturisers or moisturisers containing ingredients such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (continuing a stable dose started before screening is acceptable).
• People who have used a tanning booth or phototherapy for eczema at least twice a week within the 4 weeks before the randomization appointment.
• People who have used immunosuppressive medications (such as methotrexate, cyclosporine, azathioprine, or oral/systemic steroids) within 4 weeks or 5 half-lives before signing the consent form, whichever is longer.
• People who have received immunoglobulin or blood products within 30 days before signing the consent form.
• People who have received any marketed or investigational biologic treatment within 4 months or 5 half-lives before signing the consent form, whichever is longer.
• People who have received a live vaccine within 30 days before the first dose of the study treatment.
• People who have received any non-biologic investigational treatment within 30 days or 5 half-lives before signing the consent form, whichever is longer.
• People who have previously received the drug benralizumab (also known as FASENRA or MEDI-563).
• People who have recently changed or started allergen immunotherapy within 30 days before signing the consent form, or who expect to change it during the study.
• People who have planned major elective surgery during the study period.
• People who have already been enrolled in this same trial before.
• People who are currently enrolled in another clinical trial.
• AstraZeneca employees who were involved in planning or running this study.
• Women who are currently pregnant, breastfeeding, or lactating.

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