Phase 3 Eczema Trial, Recruiting NCT07309055 Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd Condition: Eczema
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Phase 3 Eczema Trial, Recruiting

NCT07309055
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 12 and 17 years old and weigh at least 30 kg (about 66 pounds) at the time of your first screening appointment
  • You have been diagnosed with atopic dermatitis (eczema) for at least 6 months, based on standard medical guidelines
  • Your eczema is considered moderate to severe, based on three specific measurements taken by the doctor at your screening and baseline visits (confirm with trial site for exact score details)
  • Your itch has been rated at least 4 out of 10 on average over the past week, based on daily recordings on a scale provided by the study team
  • In the past 6 months, skin creams or ointments for eczema have not worked well enough for you, or you were not able to use them safely, or you have needed stronger treatments like pills or injections for your eczema
  • You have been using a moisturizer at least twice a day, every day, for at least the 7 days before your baseline visit
  • You and your parent or legal guardian are willing to sign a consent form, can communicate clearly with the study team, and agree to follow all study requirements

Who may not be able to join:

  • You have another active skin condition (such as psoriasis or lupus affecting the skin) that could make it harder to assess your eczema
  • You have had a specific type of serious eye allergy condition (vernal or atopic keratoconjunctivitis) in the 6 months before screening
  • You have used certain skin creams or ointments for eczema — including steroid creams, calcineurin inhibitor creams, traditional Chinese medicine creams, other eczema treatments, certain medicated moisturizers, or leukotriene inhibitors — within 1 week before joining the study (confirm with trial site for details on leukotriene inhibitors specifically)
  • You have had 2 or more bleach baths in the 2 weeks before joining the study
  • You have received steroid tablets or injections, immune-suppressing medications, JAK inhibitor pills, traditional Chinese medicine taken by mouth for eczema, or light therapy (such as UV treatment) within 4 weeks before joining the study
  • You have taken part in another clinical trial or used an experimental drug or device within 8 weeks before joining the study (or longer, depending on the drug)
  • You have used a biologic medicine (such as an injection used to treat eczema or allergies) within 10 weeks before joining the study (or longer, depending on the medicine)
  • You have received a live or weakened live vaccine within 3 months before joining, or taken part in a vaccine trial within 3 months before your first dose
  • You have received a treatment that reduces certain immune cells (such as rituximab) within 6 months before joining the study
  • You have received allergy immunotherapy (allergy shots or drops) within 6 months before joining the study
  • You currently have or have previously had cancer
  • You have had major surgery in the 3 months before joining, or are expected to have major surgery during the study
  • You have serious other health conditions that the doctor feels would make joining the study unsafe, including certain hormone or gland disorders
  • You have been diagnosed with or are suspected to have a disease that weakens the immune system, including certain rare infections, within 6 months before screening
  • You have had an infection recently (within 2 weeks before joining) that needed antibiotic, antiviral, antifungal, or antiparasitic treatment, or you currently have a skin infection such as impetigo
  • You have had shingles more than once, a widespread cold sore outbreak, or a severe chickenpox-related skin reaction within the past year
  • You are suspected of having or confirmed to have active tuberculosis (TB)
  • Your blood tests show positive results for HIV, syphilis, or hepatitis C
  • Your recent blood tests or heart tracing (ECG) show certain abnormal results (confirm with trial site for specific details)
  • You are known to be allergic to the study drug or any of its ingredients

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86-0518-82342973

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Registry
ClinicalTrials.gov
Start date
21 March 2026
Est. completion
1 November 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Proportion of patients with Eczema Area and Severity (EASI)-75.; Proportion of patients with an Investigator's Global Assessment (IGA) score of either 0 or 1.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov