Phase 2 Eczema Trial, Recruiting NCT03835767 Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Condition: Eczema
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Phase 2 Eczema Trial, Recruiting

NCT03835767
Recruiting Phase 2

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:

  • Be between 3 and 21 years old
  • Already be enrolled in a specific related NIH study called "Natural History and Genetics of Food Allergy and Related Conditions" (study 15-I-0162)
  • Have a blood test result showing a very high total IgE level (a marker related to allergies) of 900 kU/L or above at the time of screening
  • Have a history of eczema (atopic dermatitis), either reported by yourself or diagnosed by a doctor
  • Be willing to take part in a food challenge test, which involves eating both a test food and a dummy (placebo) food under supervision
  • Be willing to allow your blood samples to be stored for future medical research
  • Be willing to have genetic testing done on your blood samples
  • Have a regular doctor (such as a GP or specialist) who will continue to manage your health during and outside of the study
  • Be willing to stop taking certain allergy or immune medications (specifically omalizumab or dupilumab) at least 6 months before a food challenge, and stop antihistamines and oral steroids before a food challenge (skin-applied steroids are still allowed)
  • Be able to give informed consent (or have a parent/guardian do so if under the appropriate age)

Who may not be able to join:

  • Anyone who is pregnant
  • Anyone with a known genetic disorder that causes high IgE levels or that could make a severe allergic reaction more dangerous
  • Anyone with a known heart condition
  • Anyone currently taking a type of heart/blood pressure medication called a beta-blocker
  • Anyone with an active eosinophilic gastrointestinal disorder (such as eosinophilic esophagitis, a condition causing inflammation in the digestive tract) that is currently causing symptoms — unless they are on treatment, have had a clear biopsy test within the past 18 months, or already eat the study food regularly (confirm with trial site)
  • Anyone who needs to take oral steroids (steroid tablets or liquid) regularly for a long-term health condition
  • Anyone who has used omalizumab or dupilumab in the past 6 months
  • Anyone who has any other condition that the study doctor feels would make participation unsafe or unsuitable

⚠️ 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 28 July 2026
Phase 2: approximately ~30% 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

Principal Investigator: Pamela A Guerrerio, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Phone: (301) 761-7565

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 2
Registry
ClinicalTrials.gov
Start date
19 April 2019
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Allergy to milk and peanut status; allowing for estimation of IgE thresholds that determine a subgroup with at least 50% chance of tolerance in patients with elevated total serum IgE levels and history of AD.

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: 28 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