Phase 3 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:

• Both the young person and their legal guardian must be willing to follow the study procedures and sign a consent form agreeing to take part.
• People aged 12 years old up to (but not including) 18 years old, of any gender, who weigh at least 30 kg at the time of screening and at the start of the study.
• People who have been diagnosed with atopic dermatitis (a type of eczema) using a standard set of medical criteria, with a history of the condition lasting at least 6 months.
• People whose eczema is rated as moderately severe or worse based on a standard medical scoring system (EASI score of 16 or above) at both the screening and baseline visits.
• People whose eczema severity is rated at 3 or above (out of 4) by a doctor using a standard assessment tool (IGA score) at both the screening and baseline visits.
• People where eczema affects at least 10% of their body surface area at both the screening and baseline visits.
• People experiencing significant itching, rated an average of 4 or more out of 10 over the week before the study starts.
• People who have tried prescription creams or ointments for their eczema but either found them ineffective or were found by a doctor to be unsuitable for that type of treatment, with supporting medical records available.
• People who are willing to apply a moisturiser to affected areas twice a day for at least 7 days before the study begins, and to continue doing so throughout the study.
• People who are capable of having children (for example, girls who have started their periods, or boys who have experienced nocturnal emissions) must agree to either avoid sexual activity or use reliable contraception throughout the study and for at least 3 months after the last dose, and must have no plans for pregnancy, sperm donation, or egg donation during that time.
• People who are able to complete study questionnaires, either on their own or with help from a guardian.

Who may not be able to join:

• People who have another skin condition that could interfere with how the study results are assessed.
• People who have an active or suspected parasitic infection (such as a worm infection) at the time of joining (confirm with trial site, as those who have had an active infection ruled out by tests before the study starts may still be eligible).
• People who have any history of certain serious eye conditions called vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
• People who have been diagnosed with any cancer in the past 5 years or currently have cancer, with some exceptions for certain skin cancers that have been fully treated (confirm with trial site).
• People who had a serious infection requiring hospital treatment or intravenous antibiotics in the 4 weeks before joining, or who needed antibiotic tablets for an infection in the 2 weeks before joining, where the doctor considers this a risk.
• People with a known or suspected history of a significantly weakened immune system, or who have had certain rare serious infections in the past that the doctor believes are likely to come back.
• People with signs of active tuberculosis (TB), a past TB infection that was not clearly treated, or results from tests such as chest X-rays that suggest possible TB.
• People with any serious or unstable health condition — including heart, stomach, liver, kidney, nerve, muscle, hormonal, blood, or mental health conditions — that the doctor believes could affect the person's safety or ability to complete the study.
• People who have recently received certain treatments for eczema or related conditions, including: skin creams or ointments for eczema in the 2 weeks before joining; certain traditional Chinese medicine treatments in the 4 weeks (or 1 week for topical forms) before joining; steroid tablets or immune-suppressing medications in the 4 weeks (or 5 half-lives, whichever is longer) before joining; light-based therapies (such as UV light treatment) in the 4 weeks before joining; allergen immunotherapy (allergy shots or similar) in the 6 months before joining; certain biological injection treatments (such as dupilumab) in the 4 months (or 5 half-lives, whichever is longer) before joining, or certain immune cell-reducing treatments in the 6 months before joining; a previous lack of response to treatments targeting the IL-4 and/or IL-13 pathways (such as dupilumab); or prior use of a specific drug referred to as "611" in the trial documents (confirm with trial site).
• People who have received a live or live-attenuated vaccine in the 4 weeks before joining.
• People whose blood or urine test results before the study fall outside acceptable ranges in ways the doctor considers a concern, including results relating to liver function, kidney function, or white blood cell count.
• People who test positive at screening for hepatitis B, hepatitis C, HIV, or syphilis.
• People who have taken part in another clinical drug trial within 8 weeks before joining, or within 5 half-lives of the last experimental drug used, whichever is longer.
• People who have had a problem with alcohol or drug misuse in the 6 months before joining.
• People who are known to be allergic or have a bad reaction to any ingredient in the study medication.
• People who are expected to need major surgery during the study period.
• People who are pregnant, planning to become pregnant during the study, or who are breastfeeding.
• People who the doctor considers unsuitable for the study for any other medical or personal reason.

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