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:

• People aged 18 to 65 years old at the time of signing the consent form
• People who have had atopic dermatitis (eczema) for at least 1 year, confirmed by a doctor using recognised diagnostic guidelines
• People whose eczema is rated as moderate or severe by the examining doctor (a score of 3 or 4 out of 4) 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 whose eczema severity scores on two standard medical scales (EASI ≥ 16, and a peak itch rating of at least 4 out of 10 averaged over 7 days before the baseline visit) meet the required thresholds
• People whose eczema has not responded well enough to topical (applied to skin) treatments used for at least 28 days, or for whom topical treatments are not medically suitable due to side effects or safety risks
• People who are using contraception in line with local regulations for clinical trial participants
• People who have read and signed the informed consent form

Who may not be able to join:

• People with a serious illness, significant psychiatric condition, severe depression, or a history of a suicide attempt in the past 10 years, if the trial doctor considers this makes participation unsuitable
• People who have had an active infection requiring antibiotic, antiviral, antiparasitic, antiprotozoal, or antifungal medication taken by mouth or injection within 2 weeks before the baseline visit
• People who currently have another active skin condition (such as psoriasis or lupus affecting the skin) or an active skin infection that could interfere with assessing the eczema
• People who have had a significant flare-up of their eczema within 4 weeks before the screening visit, in the trial doctor's judgement
• People who have a serious ongoing health condition that may require steroid treatment or frequent monitoring (for example, unstable asthma), in the trial doctor's judgement
• People with clinically significant abnormalities in their heart rhythm or electrical activity shown on an ECG (heart tracing), as determined by the trial doctor
• People with severe and uncontrolled hay fever, asthma, or any other severe and uncontrolled allergic condition, in the trial doctor's judgement
• People who have used prescription medicated moisturisers for eczema within 2 weeks before the baseline visit
• People with an active HIV infection confirmed by a positive HIV antibody test
• People with active hepatitis B virus infection confirmed by specific blood tests
• People with active hepatitis C virus infection confirmed by an RNA blood test (note: people with documented proof of having been cured of hepatitis C may still be considered)
• People with evidence of active or latent (inactive but present) tuberculosis
• People who have received a live or weakened live vaccine within 6 weeks before screening
• People who have had major surgery within 8 weeks before the baseline visit, or who have major surgery planned during the study period
• People who are known to have a weakened or deficient immune system
• People diagnosed with cancer within the past 5 years, with the exception of certain fully removed skin cancers (basal cell or squamous cell carcinoma of the skin) or early-stage cervical cell changes (carcinoma in situ of the cervix)
• People who have previously been treated with an anti-IL-18 therapy (confirm with trial site)
• People with a known allergy or sensitivity to any ingredient in the study medication
• People who have recently used certain eczema medications, including:
  • Dupilumab, tralokinumab, lebrikizumab, or nemolizumab within 8 weeks before baseline
  • Systemic JAK inhibitor tablets within 4 weeks before baseline
  • Any topical (applied to skin) medicated eczema treatment within 2 weeks before baseline, including topical steroids, PDE4 inhibitors, calcineurin inhibitors, topical JAK inhibitors, tars, antimicrobials, certain medical devices, or bleach baths
  • Systemic (whole-body) non-biologic treatments for eczema within 4 weeks before baseline, such as retinoids, calcineurin inhibitors, methotrexate, hydroxyurea, azathioprine, or oral/injectable steroids (note: nasal sprays, inhaled steroids, and eye or ear drops containing steroids are permitted)
  • Any investigational biologic medication within 12 weeks before screening (or 5 half-lives of the drug, whichever is longer)
  • Any investigational non-biologic medication or device within 4 weeks before screening (or 5 half-lives, whichever is longer)
  • UV-B light therapy, tanning beds, or excimer laser treatment within 4 weeks before baseline or during the study
  • PUVA light therapy within 4 weeks before baseline
  • Sedating antihistamines (such as doxepin, hydroxyzine, or diphenhydramine) within 1 week before baseline
  • Topical skin products containing urea within 1 week before baseline
  • Systemic antibiotics within 2 weeks, or topical antibiotics within 1 week, before baseline
  • Intravenous immunoglobulin (IVIg) therapy within 12 weeks before baseline
• People who are pregnant, breastfeeding, or trying to become pregnant
• People the trial doctor believes are unlikely to follow the treatment plan or study requirements

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