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:

• People who have had chronic eczema (atopic dermatitis) for at least 3 years before the start of the study, and whose condition meets a recognised set of diagnostic standards known as the Hanifin and Rajka criteria.
• People whose eczema is measured as moderate to severe at the start of the study, based on a standard scoring system called EASI (score of 12 or higher).
• People whose eczema is rated at least a 3 out of 4 on a scale used by the study doctor to assess overall disease severity.
• People whose eczema covers at least 10% of their body surface area (this applies to at least half of the overall study group).
• People who have reported an average itch score of at least 4 out of 10 over the 7 days before the study start date, based on daily ratings recorded over at least 4 of those 7 days.
• People who have been using dupilumab (an existing eczema treatment) for at least 4 months and have not had an adequate response to it.
• People who have been applying a plain, additive-free moisturiser twice daily for at least 7 days before the study start date, and who are willing to continue doing so throughout the study.

Who may not be able to join:

• People who have another active skin disease or skin infection (bacterial, fungal, or viral) that requires systemic (whole-body) treatment within 4 weeks of the study start, or that would make it difficult to assess the eczema.
• People who have had two or more past episodes of a nerve infection called herpes zoster (shingles), or one or more episodes where shingles spread widely through the body.
• People who have had one or more episodes of a widespread herpes simplex infection (including a serious eczema complication called eczema herpeticum).
• People who have a confirmed HIV infection.
• People with a current or past history of Hepatitis B or Hepatitis C infection.
• People with active tuberculosis (TB), or who do not meet the study's TB testing requirements (confirm with trial site).
• People participating in Japan who test positive for a specific fungal infection marker (beta-D-glucan), or who have two unclear test results during the screening period.
• People who have needed intravenous (IV) treatment for an infection within the past 30 days, or oral or injected antibiotic/antiviral treatment within the past 14 days.
• People with a long-term or ongoing infection that the study doctor considers would make participation unsuitable.
• People who recently tested positive for COVID-19 and have not met the required recovery timeframes set out in the study criteria (confirm with trial site for specific details).
• People who have had a stroke, heart attack, coronary stenting, heart bypass surgery, or a blood clot in a vein within the past 6 months.
• People with any unstable health condition that the study doctor believes would put them at risk by taking part.
• People with a confirmed or strongly suspected active parasitic infection that has not been ruled out by clinical or laboratory assessment before joining the study.
• People who have had an organ transplant and still require medication to suppress their immune system.
• People who have had a significant allergic reaction to the study drug or similar medications.
• People with a history of a tear or hole in the gastrointestinal (digestive) tract (other than due to appendicitis or accidental injury), inflammation of pouches in the bowel (diverticulitis), or a high risk of such an event in the doctor's assessment.
• People with conditions that could affect how the body absorbs medication, such as short bowel syndrome or certain types of weight-loss stomach surgery (gastric bypass or sleeve gastrectomy); note that a history of gastric banding does not automatically exclude a person.
• People with a history of cancer, except for certain skin cancers that have been successfully treated, or a localised cervical carcinoma in situ that has been successfully treated.

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