Phase 4 Eczema Trial, Recruiting

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:

• People who have had a confirmed diagnosis of atopic dermatitis (eczema) for at least 1 year before the screening visit, and for whom skin cream or ointment treatments have not worked well enough or are not suitable.
• People whose eczema is rated moderate-to-severe, covering more than 10% of their body surface area, with a doctor's overall severity rating of 3 or higher (on a 0–4 scale), confirmed at two separate visits.
• People whose eczema severity scores (measured using a tool called EASI) are 16 or above at both the screening and baseline visits.
• People who rate their itch as 4 or higher on a 0–10 scale.
• People who have never previously been treated with a biologic medicine (a type of injectable drug made from living cells).
• Women who could become pregnant must agree to use a highly effective and approved form of contraception, or to abstain from sex, throughout the study and for at least 17 weeks after the last injection — or confirm that permanent contraception is already in place.
• People who are willing and able to attend all required study visits and follow the study procedures.
• People who are able to understand and sign a consent form before any study-related procedures take place.

Who may not be able to join:

• People who have previously been treated with lebrikizumab or who have taken part in a previous lebrikizumab study.
• People with a history of severe allergic reactions (anaphylaxis) as defined by a specific medical classification called the Sampson criteria.
• People who have used certain skin treatments — including topical corticosteroids, calcineurin inhibitors, JAK inhibitors, or crisaborole — within 1 week before the baseline visit.
• People who have previously been treated with dupilumab or tralokinumab (other biologic medicines for eczema).
• People who have used immune-suppressing or immune-modifying drugs (such as steroid tablets, cyclosporine, methotrexate, or JAK inhibitors) within 4 weeks before the baseline visit.
• People who have had light therapy or photochemotherapy for eczema within 4 weeks before the baseline visit.
• People who have taken part in another clinical trial drug study within 8 weeks, or within 5 half-lives of that drug (whichever is longer), before the baseline visit.
• People who have received cell-depleting biologic medicines (such as rituximab) within the past 6 months.
• People who have used other biologic medicines within 16 weeks, or within 5 half-lives of that drug (whichever is longer), before the baseline visit.
• People who have used prescription moisturisers within 7 days before the baseline visit.
• People who have regularly used a tanning booth or salon (more than twice per week) within 4 weeks of the screening visit.
• People who have received a live or live-attenuated vaccine within 12 weeks before the baseline visit, or who plan to receive one during the study.
• People with an uncontrolled ongoing illness that regularly requires bursts of oral steroid treatment (for example, severe uncontrolled asthma requiring systemic steroids or hospitalisation for more than 24 hours).
• People with an active infection — either a general infection requiring antibiotic, antiviral, antifungal, or antiparasitic treatment within 2 weeks before the baseline visit, or a skin infection within 1 week before the baseline visit. (The trial site notes that people may be able to reapply once the infection has cleared.)
• People with signs of active or ongoing liver disease such as hepatitis, or known liver cirrhosis.
• People with an active parasitic infection inside the body, or those considered at high risk of one.
• People with a known or suspected history of serious immune system problems, including a history of serious or unusual infections such as tuberculosis, histoplasmosis, or aspergillosis.
• People who are HIV positive or who test positive for HIV at screening.
• People whose blood, urine, or chemistry test results are considered clinically significant by the investigating doctor.
• People with other skin conditions that could interfere with how the study assessments are carried out.
• People with a history of cancer within the past 5 years before the screening visit, with the exception of certain fully treated and resolved skin cancers or cervical carcinoma in situ (confirm with trial site).
• People with serious other illnesses that, in the doctor's judgement, could make participation unsafe or unreliable, or could interfere with study results.
• Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

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