Phase 2 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 are male or female, aged between 18 and 65 years old at the time of giving consent.
• People who weigh at least 40 kg at the time of their screening appointment.
• People who have a doctor-confirmed diagnosis of moderate-to-severe atopic dermatitis (eczema), based on at least 12 months of symptoms assessed using a standard set of diagnostic criteria.
• People whose eczema scores at least 16 on a standard severity measurement scale (called EASI) at both the screening and baseline visits.
• People whose eczema is rated at least 3 out of 5 on a standard investigator assessment scale (called vIGA-AD) at both the screening and baseline visits.
• People whose eczema covers at least 10% of their body surface area at both the screening and baseline visits.
• People who report an average itch intensity score of at least 3 on a standard rating scale, based on daily recordings over the 7 days before being assigned to a treatment group.
• People who have not responded well enough to at least 4 weeks of treatment with prescription skin creams (such as topical corticosteroids or topical calcineurin inhibitors) within the 6 months before screening, or who have required systemic (whole-body) treatment for eczema in that same period.
• People who have been applying a plain, additive-free moisturiser twice daily for at least 1 week before the baseline visit.
• Female participants who have a negative pregnancy test at screening, and all participants who are able to have children must use two acceptable forms of contraception throughout the study and for 16 weeks (or 5 half-lives of the study drug, whichever is longer) after the last dose — acceptable methods include hormonal contraceptives, condoms with spermicide, diaphragms or caps with spermicide, intrauterine devices, or surgical sterilisation; postmenopausal women (defined by 12 consecutive months without a period and confirmed by a blood test) are also eligible (confirm with trial site).
• People who are able to give written informed consent.
• People who are willing and able to attend all scheduled visits, follow the treatment plan, complete required tests, and meet all other study requirements.

Who may not be able to join:

• People who are pregnant or currently breastfeeding.
• People who test positive for active hepatitis B virus or hepatitis C virus.
• People who test positive for HIV, or who have a known history of HIV infection.
• People who have had a problem with alcohol or drug misuse within the past year, in a way that could affect their ability to safely take part, as judged by the study doctor.
• People who have a significant, active, or severe illness affecting the digestive system, heart, nervous system, mental health, metabolism, kidneys, liver, lungs (except for uncomplicated allergic rhinitis or allergic asthma), immune system, hormones, or who have diabetes, obesity (BMI of 35 or above), or a serious infection, as judged by the study doctor.
• People who have a significant history of serious allergic reactions to medications (such as sulfonamides or penicillin), or who have had a drug allergy reaction in a previous clinical trial.
• People who have ever had a severe, life-threatening allergic reaction (anaphylaxis).
• People who have any condition that, in the study doctor's opinion, could put them at risk or affect the reliability of the study results.
• People who have used prescription skin creams for eczema (topical corticosteroids or topical calcineurin inhibitors) within 7 days before the baseline visit.
• People who have received immunoglobulin or blood products within the 3 months before the baseline visit.
• People who have received a biologic medicine (including experimental biologic treatments) within 3 months or 5 half-lives of that medicine — whichever is the longer period — before the baseline visit.
• People who have taken part in another drug trial within 8 weeks, or within 5 half-lives of the experimental drug (if known) — whichever is the longer period — before the baseline visit.
• People who started using prescription moisturisers, or moisturisers containing ingredients such as ceramide, hyaluronic acid, urea, or filaggrin-related products, during the screening period.
• People who started using sedating antihistamines during the screening period (non-sedating antihistamines at a stable dose may be acceptable — confirm with trial site).
• People who are employed by or professionally involved in running this study.
• People who have used a tanning booth or sunbed regularly (2 or more times per week) in the 4 weeks before the baseline visit.
• People who have received cell-based immunotherapy within 3 months before the baseline visit.
• People who have used certain medications within specific timeframes before starting the study drug, including: systemic (whole-body) corticosteroids within 4 weeks; leukotriene modifiers within 4 weeks; cyclosporine or other immune-suppressing medicines within 4 weeks; interferon-gamma within 12 weeks or other immune-modifying drugs within 4 weeks; allergen immunotherapy (desensitisation treatment) within 1 year; or JAK inhibitor medicines within 4 weeks.
• People who have had light therapy (phototherapy) for their eczema within 4 weeks before starting the study drug.
• People who have received a live vaccine within 12 weeks before starting the study drug.
• People who have other skin conditions that could affect how the study assessments are carried out.
• People who have a known or suspected history of a weakened immune system, including a history of serious opportunistic infections such as tuberculosis, as judged by the study doctor.
• People who have an active infection currently requiring treatment with antibiotics or antiviral or antifungal medicines (within 2 weeks before the baseline visit), or a skin infection (within 1 week before the baseline visit).
• People who have had a cancer diagnosis within the past 5 years, except for certain fully treated and resolved skin cancers (basal cell or squamous cell carcinoma) or fully treated cervical carcinoma in situ.
• People who expect to need any medications or procedures that are not permitted during the study.
• People who expect to undergo a major surgical procedure during the study period.
• People considered at high risk of parasitic infection, based on both having risk factors (such as living in or recently travelling to areas where parasitic infections are common, having long-term digestive symptoms, or having a weakened immune system) and showing evidence of parasitic infection in a stool test (this test is only done in people with risk factors and an elevated level of a specific type of blood cell called eosinophils).

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