Phase 4 Eczema Trial, Recruiting NCT05268107 Sponsor: University of Michigan Condition: Eczema
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Phase 4 Eczema Trial, Recruiting

NCT05268107
Recruiting Phase 4

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 have been diagnosed with atopic dermatitis (eczema) for at least 2 years, and this diagnosis has been confirmed at your screening visit using standard medical guidelines.
  • Your eczema is moderate-to-severe, covering more than 10% of your body, and a doctor has rated it at least a 3 out of 4 in severity at both your screening and baseline visits.
  • If you are a woman who could become pregnant, you must agree to use an approved form of contraception, or commit to not having sex, throughout the study and for 12 weeks after your last injection.
  • You are willing and able to attend all required study visits and follow all study procedures.

Who may not be able to join:

  • You weigh less than 30 kilograms (about 66 pounds).
  • You have had an asthma attack serious enough to require a hospital stay in the past 12 months.
  • Your asthma has not been well-controlled in the past 3 months (for example, symptoms more than twice a week, waking at night due to asthma twice or more per week, or asthma affecting your daily activities).
  • You have a history of asthma and scored below 19 on a standard asthma control test (confirm with trial site).
  • You have a current diagnosis of chronic obstructive pulmonary disease (COPD) or chronic bronchitis.
  • You have had a skin infection in the week before your baseline visit, or any infection requiring prescription medication (antibiotics, antivirals, antifungals, or antiparasitic treatment) in the 2 weeks before your baseline visit.
  • You have had a confirmed or suspected COVID-19 infection within 4 weeks before your screening or baseline visit.
  • You received a COVID-19 vaccine within 4 weeks before your baseline visit.
  • You have previously been treated with a medication called dupilumab (Dupixent).
  • You are pregnant, breastfeeding, or planning to become pregnant during the study.
  • You have a history of certain cancers in the past 5 years (some exceptions for specific treated skin cancers may apply — confirm with trial site).
  • You have had a serious allergic reaction (including anaphylaxis) to a monoclonal antibody treatment or to lidocaine (a common local anaesthetic).
  • You have a known active or latent (dormant) tuberculosis infection.
  • You have a known or suspected weakened immune system, or a history of unusually frequent, severe, or long-lasting infections (confirm with trial site).
  • You have, or have had, certain other skin conditions such as psoriasis, Netherton syndrome, cutaneous T-cell lymphoma, contact dermatitis, chronic actinic dermatitis, or dermatitis herpetiformis.
  • You are expected to have major surgery during the study period.
  • You are currently taking part in another clinical trial of a drug or medical device, or have done so in the past 8 weeks before screening.
  • You have had a problem with alcohol or substance misuse in the past 6 months.
  • You have a history of poor wound healing or keloid (raised scar) formation.

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 21 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Johann Gudjonsson, MD, University of Michigan

Phone: 734-936-7519

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 4
Registry
ClinicalTrials.gov
Start date
25 January 2023
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Difference in inflammatory response to dupilumab between Caucasian, Asian and African American patients with atopic dermatitis as measured by change in expression of interleukin4 (IL4) from week 0 to 2.

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: 21 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