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:

• Adults aged 18 to 75 years (inclusive) with a body mass index (BMI) of 19 or above
• People who have been fully informed about the trial and have agreed to take part by signing a consent form
• People who have been diagnosed with atopic dermatitis (eczema) by a doctor using a recognised set of diagnostic criteria, and who have had the condition for at least 1 year before the screening visit
• People whose eczema is rated as moderate to severe at the time of screening and at the start of the trial, based on all four of the following: a doctor's severity score of 3 or 4 (on a scale called IGA); a rash severity score of 16 or more (on a scale called EASI); an average itch score of 4 or more out of 10 over the past week; and eczema affecting at least 10% of the body surface
• People whose eczema has not responded well enough to standard skin treatments — such as topical corticosteroids, calcineurin inhibitors, or light therapy — used for at least 4 weeks in the past 6 months, or who cannot use those treatments for medical reasons, and whose condition requires a treatment that works throughout the whole body
• People who have been using a basic moisturiser twice a day at a consistent amount for at least 7 days before the first dose, and who agree to continue using it throughout the study

Who may not be able to join:

• People who are known to be allergic to the study drug or any of its ingredients, or who have had an allergy or intolerance to other oral JAK inhibitor medicines
• People who have used certain other treatments recently, including: other oral JAK inhibitors within the past month, or who previously had no response or intolerance to oral JAK inhibitors; certain specific biologic medicines within 6 weeks before the start of the trial; other systemic biologic treatments (other than dupilumab) within 3 months before the start; any topical eczema treatments within 1 week before the start; any systemic (whole-body) eczema treatments within 4 weeks before the start; phototherapy (light treatment) within 4 weeks before the start; allergy immunotherapy within 6 months before the start; certain drugs that affect how the body processes medicines, within 2 weeks before the start; or treatments that deplete white blood cells (confirm with trial site)
• People who are currently enrolled in another interventional clinical study, or who received any investigational drug or device treatment within 3 months before the start of the trial (or within 5 drug half-lives, whichever is longer)
• People who have a history of serious conditions affecting the digestive, heart, lung, muscle and joint, hormonal, nervous, blood, or immune systems, or who have had major surgery, or any other condition the doctor considers may affect the trial (confirm with trial site)
• Women who are pregnant or breastfeeding
• People who are able to have children, or whose partner is able to have children, and who are not willing to use effective contraception from the time of signing the consent form until 90 days after the last dose
• People who plan to donate eggs or sperm during the trial or within 3 months after the last dose
• People with a past history of cancer, including blood cancers or solid tumours — except for certain types of skin cancer (basal cell carcinoma or squamous cell carcinoma of the skin) that have been fully removed or cured
• People who have had major surgery within 4 weeks before screening, or who have surgery planned during the screening period
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis (with certain exceptions for some results that fall within normal ranges — confirm with trial site)
• People with very low or very high blood pressure, or whose high blood pressure is not well controlled despite taking two or more blood pressure medications, or who have severe sleep apnoea
• People with certain abnormal heart readings on an ECG, including a prolonged PR interval, slow heart rate, or prolonged QT interval (specific thresholds differ for males and females — confirm with trial site)
• People with a history of serious heart or stroke-related conditions that are poorly controlled, such as heart attack, unstable chest pain, heart failure, congenital heart disease, stroke, or a mini-stroke; or people who have had bleeding in the brain within the past year, or who have a tendency to bleed easily
• People with a history of certain heart rhythm problems, including a slow heart rate, second or third degree heart block, cardiac arrest lasting more than 3 seconds, or sick sinus syndrome (confirm with trial site)
• People with uncontrolled diabetes, defined as a long-term blood sugar measure (HbA1c) above 9%
• People with other active skin conditions (such as psoriasis or lupus affecting the skin) or skin features such as extensive scarring, tattoos, or pigmentation that could affect how the eczema is assessed
• People with moderate or severe nerve damage affecting the limbs (grade 2 or higher on a standard medical scale)
• People with a current or past history of a significant immune deficiency condition
• People with a history of widespread herpes zoster (shingles) or widespread herpes simplex infection
• People with significant lung conditions such as chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, or severe or poorly controlled asthma (mild intermittent asthma not requiring regular treatment may be acceptable — confirm with trial site)
• People who have needed intravenous antibiotics in hospital within the past 30 days, or oral antibiotics for an active infection within the past 14 days before screening
• People who have received a live or weakened (attenuated) vaccine within 30 days before screening, or who plan to receive one during the study or within 30 days after the last dose
• People with active tuberculosis (TB) in the past year, or a positive TB test in the past month — with some exceptions for people who have already started and completed at least one month of preventive treatment for latent (inactive) TB under an approved guideline (confirm with trial site)
• People with certain abnormal blood test results at screening, including low white blood cell count, low neutrophil count, low lymphocyte count, low platelet count, or low haemoglobin levels
• People with certain abnormal liver blood test results at screening, including raised bilirubin, AST, or ALT levels above 1.5 times the upper limit of the normal range
• People with moderate or severe kidney impairment, based on kidney function tests falling below certain thresholds (confirm with trial site)
• People with a history of heavy alcohol use within the past year (defined as more than 21 standard drinks per week for men, or more than 14 per week for women), or a history of drug abuse
• People who have received certain specific treatments within defined timeframes before the trial, including intravenous immunoglobulin or plasma exchange, certain heart rhythm medications, other biologic medicines (other than dupilumab) within 12 weeks, long-acting blood-thinning medications within 4 weeks, or antiplatelet drugs within 1 week before the first dose (low-dose aspirin up to 100 mg per day for heart protection may be allowed — confirm with trial site)
• People who have lost 400 mL or more of blood within 12 weeks before screening (such as through injury, blood collection, or donation), or who plan to donate blood during the study or within 1 month after completing it
• People who, for any other reason, may not be able to complete the study, or whom the investigator considers unsuitable

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