Phase 2 Alopecia Areata Trial, Recruiting NCT05551793 Sponsor: Emma Guttman Condition: Alopecia Areata
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Phase 2 Alopecia Areata Trial, Recruiting

NCT05551793
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 a man or woman aged 18 or older.
  • You are able to understand the study and are willing to sign a consent form before taking part.
  • You are able to attend scheduled appointments and follow the study requirements.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before starting and agree to use effective contraception during the study and for at least 28 days after the last dose.
  • If you are a woman who cannot become pregnant, you have documentation of infertility, have been through menopause for at least one year, or have had a hysterectomy or surgery to remove both ovaries or fallopian tubes.
  • You have had moderate to severe alopecia areata (hair loss covering at least 50% of the scalp) for at least 6 months, or you have lost 95% or more of your scalp hair (total or universal hair loss).
  • You have a blood test result showing a certain immune marker (IgE) above 200, and/or you or a close family member have a history of allergic conditions such as hay fever, eczema, or asthma.
  • Your blood test results fall within specific acceptable ranges for white blood cells, platelets, kidney function, liver function, and red blood cells (confirm with trial site for exact values).
  • You are considered to be in generally good health based on your medical history, a physical examination, and blood tests.

Who may not be able to join:

  • You are currently pregnant or breastfeeding.
  • Your hair loss has more than one cause, or the cause is unclear — for example, hair loss due to pulling, scarring, pregnancy, medication, stress-related shedding, or advanced pattern baldness.
  • You have had alopecia areata with no signs of any hair regrowth for 7 or more years since your last episode of hair loss.
  • You have severe, uncontrolled asthma or have had a life-threatening asthma attack even while on appropriate asthma medication.
  • You currently have an active bacterial, viral, or parasitic infection, or you have a history of frequent serious infections that required treatment with antibiotics given into a vein or by mouth.
  • You have a known or suspected problem with your immune system that leaves you unable to fight infections normally.
  • You have a serious, ongoing, or hard-to-control condition affecting your kidneys, liver, blood, gut, metabolism, hormones, lungs, heart, or nervous system.
  • You have active hepatitis B, hepatitis C, HIV, or untreated latent (inactive) tuberculosis (confirm with trial site regarding testing requirements).
  • You have or are suspected to have a blood cancer or lymph gland disorder, or you have had any cancer in the past 5 years — with the exception of certain fully treated skin cancers or cervical cancer that has not spread.
  • You received a live vaccine (such as MMR or chickenpox) within 30 days before joining the study.
  • You have unusual or significant abnormal blood test results that could affect how study results are interpreted.
  • You have any other medical or mental health condition that the study doctor believes could put you at extra risk or prevent you from completing the study visits.
  • You have previously had a serious allergic or harmful reaction to any ingredient in the study drug.
  • You have used certain immune-suppressing medicines (such as cyclosporine, methotrexate, azathioprine, or certain steroid treatments) or light therapy (UV phototherapy) within 4 weeks before joining the study.
  • You have taken a JAK inhibitor tablet (such as tofacitinib, ruxolitinib, or baricitinib) within 12 weeks before your baseline visit.
  • You have previously been treated with dupilumab.
  • You have used steroid creams or certain other skin creams (tacrolimus or pimecrolimus) within 1 week before your baseline visit.
  • You currently use or plan to use anti-retroviral (HIV) medication at any point during 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
Sponsor
Emma Guttman
Registry
ClinicalTrials.gov
Start date
10 April 2023
Est. completion
30 November 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in the 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