Phase 3 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:

For children joining from a previous related trial (Extension Cohort):

• Children aged 2 to under 12 years old who have already completed the full treatment phase of a qualifying earlier study related to this trial
• Female participants must not be pregnant or breastfeeding, and those who could become pregnant must use a highly effective form of contraception (such as abstinence) during the study and for at least 28 days after the last dose

For children joining this trial fresh (De Novo Cohort):

• Children aged 6 to under 12 years old at the time of joining the study
• Children who have had a confirmed diagnosis of chronic eczema (atopic dermatitis) for at least 6 months before the screening visit, confirmed again at screening and at the start of the study, meeting a specific set of medical criteria
• Children whose eczema is classed as moderate-to-severe at the start of the study, based on specific skin assessment scores measured by the trial doctors
• Children who have tried topical skin treatments (such as creams or ointments) for at least 4 weeks within the past 6 months without enough improvement, and who are considered suitable for a systemic (whole-body) treatment
• Children who weigh at least 15 kg

Who may not be able to join:

For children joining from a previous related trial (Extension Cohort):

• Children who have any medical or psychiatric condition, including thoughts of suicide in the past year or suicidal behaviour in the past 5 years, or abnormal lab results, that could increase the risk of being in the study or that the investigator considers unsuitable
• Children whose behavioural/emotional screening score is 17 or above may need to be assessed by a specialist before the trial site can consider their participation
• Children who need to take any medications that are not permitted during this study
• Children who need to receive live vaccines during the study treatment period or within 6 weeks after finishing the study treatment
• Children who are still experiencing an ongoing side effect from the earlier study that the investigator or sponsor considers a safety concern, or who are currently being monitored due to a safety issue
• Children who left the earlier study before completing treatment, or who met any reason for stopping in the earlier study that the investigator or sponsor still considers an ongoing safety concern

For children joining this trial fresh (De Novo Cohort):

• Children who have any medical or psychiatric condition, including thoughts of suicide in the past year or suicidal behaviour in the past 5 years, or abnormal lab results, that could increase the risk of being in the study or that the investigator considers unsuitable
• Children whose behavioural/emotional screening score is 17 or above may need to be assessed by a specialist before the trial site can consider their participation
• Children who have had a serious skin infection requiring antibiotic treatment in the 2 weeks before the study start, or a surface-level skin infection in the week before the study start
• Children who have had a serious internal infection requiring hospital care or intravenous antibiotics within 1 month before the study start
• Children who have had a widespread episode of the herpes zoster or herpes simplex virus, or repeated episodes of localised herpes zoster
• Children who have HIV, hepatitis B, or hepatitis C infection
• Children who have active tuberculosis (TB) or TB that has not been properly treated
• Children who have other skin conditions such as psoriasis, seborrheic dermatitis, or lupus that could interfere with assessing their eczema
• Children who have a history of a bone growth disorder (skeletal dysplasia)
• Children who have a history of detached retina
• Children who have a history of, or conditions linked to, problems with blood clotting or platelet function
• Children who have a prior history of leukaemia, lymphoma, sarcoma, or any other cancer
• Children who have an immune system disorder, or who have a close family member with an inherited immune system condition
• Children who have previously been treated with a type of medicine called a systemic JAK inhibitor for their eczema
• Children who have received a live vaccine within 6 weeks before the study start, or who will need one during or within 6 weeks after the study treatment
• Children who need to take certain medications that strongly affect how the study drug is processed by the body (strong inhibitors or inducers of CYP2C19 or CYP2C9 enzymes) (confirm with trial site)
• Children who have taken part in another clinical drug study within 30 days, or within 5 half-lives of that drug (whichever is longer), before the study start
• Children whose blood test results show certain abnormalities in liver function, kidney function, or blood cell counts, as defined by the trial's specific thresholds
• Staff members working directly on this trial, their family members, or employees of the study sponsor who are directly involved in running the trial

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