Testing a new injection treatment for severe skin itching and inflammation in teens

Plain-English translation of NCT07309055 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This study is testing whether SHR-1819, a new injectable medication, can safely and effectively treat severe eczema (atopic dermatitis) in teenagers. Researchers will compare this medication against a placebo (a shot with no active medicine) to see if it truly helps reduce the itching, redness, and inflammation that come with severe eczema. The trial will enroll about 201 teenagers from multiple centers.

Many teenagers with severe eczema don't get enough relief from creams, ointments, and other topical treatments. This trial is testing whether this new medication could offer a better option for young people whose eczema significantly impacts their quality of life.

Do you qualify?

You likely qualify if…

you are between 12 and 17 years old and weigh at least 30 kilograms (about 66 pounds)
you have been diagnosed with eczema for at least 6 months
you currently have moderate-to-severe eczema that covers a significant portion of your skin and causes intense itching
you have tried topical creams or ointments in the past 6 months without adequate improvement, or these treatments haven't been safe for you
you are willing to apply moisturizer twice daily and commit to the study schedule
you and your parents or legal guardians consent to participate and understand the study requirements

You likely don't qualify if…

you have other active skin conditions (such as psoriasis or lupus) that could interfere with measuring your eczema
you have had certain eye inflammation conditions (vernal or atopic keratoconjunctivitis) in the past 6 months
you are currently taking topical steroids, topical calcineurin inhibitors, or other topical eczema medications—these must be stopped before the study begins
you have received more than one bleach bath in the 2 weeks before the study starts
you are pregnant, breastfeeding, or unable to use reliable contraception during the trial

What participation looks like

If you're selected, you'll be randomly assigned to receive either the new medication or a placebo injection at different dose levels. You'll visit the study clinic regularly for injections and check-ups where doctors will examine your skin and ask about your symptoms and itching. The study will track how well the medication works and monitor you for any side effects throughout the trial period.

AI-generated summary from trial data · Jun 3, 2026 · Not medical advice

Trial locations(2 sites)

China

The First Affiliated Hospital of China Medical University, Shenyang, Liaoning

Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine, Shanghai, Shanghai Municipality