Phase 2 Alopecia Areata Trial, Recruiting NCT05866562 Sponsor: Icahn School of Medicine at Mount Sinai Condition: Alopecia Areata
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Phase 2 Alopecia Areata Trial, Recruiting

NCT05866562
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:

  • You are between 6 and 17 years old, and a parent or legal guardian is able to sign the consent forms on your behalf.
  • You are able to attend all required study visits and follow the study schedule.
  • If you are a girl who could potentially become pregnant, you must have a negative pregnancy test at the start of the study and agree to use an approved form of birth control during the study and for at least 28 days after the last dose of the study medicine.
  • You have had moderate to severe hair loss (alopecia areata) covering at least 50% of your scalp for at least 6 months, as measured by a specific scoring tool.
  • You have a higher-than-normal level of a certain allergy-related protein in your blood (IgE ≥ 200), and/or you or a family member have a history of allergic conditions such as asthma, eczema, hay fever, food allergies, or a condition called eosinophilic esophagitis.
  • Your doctor considers you to be in generally good health based on your medical history, a physical exam, and blood tests.

Who may not be able to join:

  • You are unwilling or unable to give consent or follow the study rules.
  • You are currently pregnant or breastfeeding.
  • Your hair loss has more than one cause, or the cause is unclear — for example, if it is related to tight hairstyles, scarring, pregnancy, certain medications, or a common type of age-related hair thinning at an advanced stage.
  • You have had alopecia areata for 7 or more years with no sign of any hair growing back since your last episode of hair loss.
  • You have severe asthma that is not well controlled, including two or more serious asthma episodes in the past year that needed steroid treatment or a hospital stay, or you have had a life-threatening asthma attack even while on asthma medication.
  • You currently have an active bacterial, viral, or parasitic infection, or you have a history of serious infections that keep coming back and require antibiotic treatment.
  • Your doctor believes your immune system is weakened or not working properly.
  • You have a serious, ongoing, or hard-to-control condition affecting your kidneys, liver, blood, digestive system, metabolism, hormones, lungs, heart, or nervous system.
  • You have active hepatitis B, hepatitis C, or HIV, or you test positive for HIV and your doctor considers you to be at high risk for the disease.
  • You have, or are suspected to have, a blood or lymph system cancer, or you have had any cancer in the past 5 years (except for certain fully treated, non-spreading skin or cervical cancers).
  • You received a live vaccine within 28 days before being assigned to a treatment group in the study.
  • Your doctor believes there are other medical reasons that could put you at risk or affect the study results (confirm with trial site).
  • You have had a serious allergic or bad reaction to any ingredient in the study drug in the past.
  • You have used certain immune-suppressing medicines — including cyclosporine, steroid injections, methotrexate, JAK inhibitor tablets, or UV light therapy — within 4 weeks before the start of the study.
  • You have previously been treated with a medicine called dupilumab.
  • You have used certain skin creams or ointments (such as steroid creams, tacrolimus, or pimecrolimus) within 1 week before the start of the study.

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: Emma Guttman-Yassky, MD, PhD, Icahn School of Medicine at Mount Sinai

Phone: 212-241-3288

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
11 July 2024
Est. completion
17 August 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in the Severity of Alopecia Tool (SALT) score

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