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:

• The person weighs at least 10 kg, and both their weight and height are above the 5th percentile for their age on standard growth charts at the start of the trial.
• The person has been diagnosed with Atopic Dermatitis (eczema) based on recognised medical criteria, with symptoms that started at least 6 months before the trial begins.
• The person's eczema is assessed as moderate-to-severe at the start of the trial, covering at least 10% of the body, with scores above set thresholds on standard eczema severity and itch rating scales (confirm with trial site for exact score requirements in your country).
• The person meets at least one of the following treatment history conditions (more than one may apply):
• For the main randomised group: Outside the US, the person has a documented history of not responding well to, or not tolerating, standard topical creams or ointments for eczema, or those treatments are not medically suitable for them due to high disease burden.
• For people who have never used dupilumab: The person has not responded well to another systemic (whole-body) treatment for eczema (not dupilumab or oral steroids), or those treatments are not medically suitable for them.
• The person has had two or more courses of oral steroid treatment (each lasting at least 14 days) within 6 months before screening, or their eczema has returned within 4 months of stopping oral steroids.
• For people who have previously used dupilumab: The person stopped dupilumab for a non-medical reason, such as loss of insurance coverage or other logistical barriers unrelated to safety or effectiveness.
• For the dupilumab inadequate response/medically inadvisable group: The person previously did not respond well to or could not tolerate dupilumab, or dupilumab is not medically suitable for them, and they also have a documented history of not responding well to standard topical eczema treatments.

Who may not be able to join:

• People who currently have, or have a history of, other active skin conditions (such as psoriasis, Netherton syndrome, or lupus affecting the skin) or skin infections requiring whole-body treatment within 4 weeks before the trial starts, or conditions that could make it hard to accurately assess the eczema.
• People who have used topical eczema treatments (other than moisturisers) within 7 days before the trial starts, or who have used certain other eczema treatments within specific timeframes — including systemic treatments within 4 weeks, dupilumab within 8 weeks, other targeted biologic treatments within 12 weeks or longer, or phototherapy/laser/tanning treatments within 4 weeks.
• People with a known history of retinal detachment, previous cataract surgery, significant eye injury, or a known eye condition present from birth.
• People in the main randomised group who have a confirmed or suspected parasitic infection, unless testing has ruled out an active infection before joining the trial.

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